The Medical Device Business Journal — Medical Device News & Articles | MassDevice
TOTAL 510(k)s THIS PERIOD 224 TOTAL WITH SUMMARIES 212 TOTAL WITH STATEMENTS 12
DEVICE: PREFERRED BLOOD GLUCOSE MONITORING SYSTEM PRODIGY DIABETES CARE, LLC 510(k) NO: K122338(TRADITIONAL) ATTN: E.J. SMITH PHONE NO : 888 729 9674 1468 HARWELL AVENUE SE DECISION MADE: 05-NOV-13 CROFTON MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNISTRIP 1 UNISTRIP TECHNOLOGIES, LLC 510(k) NO: K113135(TRADITIONAL) ATTN: E.J. SMITH PHONE NO : 888 729 9674 1468 HARWELL AVE SE DECISION MADE: 06-NOV-13 CROFTON MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST, MIDSTREAM TEST AND DIP/CARD STRIP UCP BIOSCIENCES, INC. 510(k) NO: K131236(TRADITIONAL) ATTN: NANCY CHEN PHONE NO : 408 392 0064 1445 KOLL CIRCLE, STE. 111 SE DECISION MADE: 07-NOV-13 SAN JOSE CA 95112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV BECTON, DICKINSON AND COMPANY 510(k) NO: K132456(TRADITIONAL) ATTN: GREGORY P PAYNE, RAC PHONE NO : 858 795 7890 10865 ROAD TO THE CURE SUITE 200 SE DECISION MADE: 07-NOV-13 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS SIEMENS HELATHCARE DIAGNOSTICS INC510(k) NO: K131275(TRADITIONAL) ATTN: ELISABETH WARINER PHONE NO : 916 374 3183 1584 ENTERPRISE BLVD. SE DECISION MADE: 08-NOV-13 WEST SACRAMENTO CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS DIASORIN, INC. 510(k) NO: K132515(TRADITIONAL) ATTN: CAROL A DEPOUW PHONE NO : 651 351 5850 1951 NORTHWESTERN AVE. P.O. BOX 28SE DECISION MADE: 08-NOV-13 STILLWATER MN 55082 0285 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM CO-INNOVATION BIOTECH CO., LTD. 510(k) NO: K132085(TRADITIONAL) ATTN: HONG FENG PHONE NO : 86 20 62867285 NO. 13 YANYUAN ROAD. TIANHE DISTRISE DECISION MADE: 12-NOV-13 GUANGZHOU, GUANGDONG CH 510507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES OMEGA LABORATORIES, INC. 510(k) NO: K131128(TRADITIONAL) ATTN: ROBERT J BARD, JD PHONE NO : 248 573 5040 400 NORTH CLEVELAND SE DECISION MADE: 13-NOV-13 MOGADORE OH 44260 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GSP NEONATAL BIOTINIDASE KIT WALLAC OY 510(k) NO: K131284(TRADITIONAL) ATTN: JEANETTE SCHIER-PUGSLEY PHONE NO : 781 663 6025 940 WINTER STREET SE DECISION MADE: 14-NOV-13 WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 AST ST MEROPENEM BIOMERIEUX, INC. 510(k) NO: K132507(TRADITIONAL) ATTN: NATHAN HARDESTY PHONE NO : 314 731 8666 595 ANGLUM RD. SE DECISION MADE: 15-NOV-13 HAZELWOOD MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ILLUMINA MISEQDX TM CYSTIC FIBROSIS CARRIER SCREEN ASSAY, ILLUMINA MISEQDX TM CYSTIC FIBROSIS DIAGNOSTIC ASSAY ILLUMINA, INC. 510(k) NO: K124006(TRADITIONAL) ATTN: LEANNE M KIVIHARJU PHONE NO : 858 202 4500 5200 ILLUMINA WAY SE DECISION MADE: 19-NOV-13 SAN DIEGO CA 92122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ILLUMINA MISEQDX(TM) CYSTIC FIBROSIS DIAGNOSTIC ASSAY ILLUMINA, INC. 510(k) NO: K132750(TRADITIONAL) ATTN: BRYAN SCHNEIDER PHONE NO : 858 202 4500 5200 ILLUMINA WAY SE DECISION MADE: 19-NOV-13 SAN DIEGO CA 92122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR RANDOX LABORATORIES, LTD. 510(k) NO: K123977(TRADITIONAL) ATTN: PAULINE ARMSTRONG PHONE NO : 44 28 94422413 55 DIAMOND RD. SE DECISION MADE: 21-NOV-13 CRUMLIN, COUNTY ANTRIM UK BT29 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFLAMMADRY EXTERNAL CONTROLS RAPID PATHOGEN SCREENING, INC. 510(k) NO: K132066(TRADITIONAL) ATTN: DOUGLAS BUESCHEL PHONE NO : 941 556 1850 7227 DELAINEY COURT SE DECISION MADE: 21-NOV-13 SARASOTA FL 34240 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIRTUOSO SYSTEM FOR IHC ER (SPI) VENTANA MEDICAL SYSTEMS, INC. 510(k) NO: K130515(TRADITIONAL) ATTN: ERIKA AMMIRATI PHONE NO : 650 949 2768 575 SHIRLYNN COURT SE DECISION MADE: 22-NOV-13 LOS ALTOS CA 94022 510(k) STATEMENT
DEVICE: GLB BENECHECK PREMIUM GLU MONITORING SYSTEM GENERAL LIFE BIOTECHNOLOGY CO., LT510(k) NO: K123090(TRADITIONAL) ATTN: FENG-YU LEE PHONE NO : 949 951 3046 27001 LA PAZ ROAD SUITE 266B SE DECISION MADE: 22-NOV-13 MISSION VIEJO CA 92691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT SIEMENS HEALTHCARE DIAGNOSTICS, IN510(k) NO: K133067(TRADITIONAL) ATTN: KIRA GORDON PHONE NO : 914 524 2996 511 BENEDICT AVE SE DECISION MADE: 22-NOV-13 TARRYTOWN NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER, CARESENS N MULTI BLO I-SENS, INC. 510(k) NO: K132288(SPECIAL) ATTN: CHAE YUN LIM PHONE NO : 822 91 66191 27-36 GWANGUN-RO, NOWON-GU SE DECISION MADE: 22-NOV-13 SEOUL KS 139-845 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRODIGY CHOICE PRODIGY DIABETES CARE, LLC 510(k) NO: K122340(TRADITIONAL) ATTN: E J SMITH PHONE NO : 888 729 9674 1468 HARWELL AVENUE SE DECISION MADE: 26-NOV-13 CROFTON MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD MAX STAPHSR ASSAY, INSTRUMENT GENEOHM SCIENCES CANADA, INC. (BD 510(k) NO: K132822(TRADITIONAL) ATTN: PATRICIA DIONNE PHONE NO : 418 780778 3 2555 BOUL. DU PARC-TECHNOLOGIQUE SE DECISION MADE: 26-NOV-13 QUEBEC CA G1P 4S5 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM PRIMERADX 510(k) NO: K132726(TRADITIONAL) ATTN: FAYYAZ MEMNON PHONE NO : 508 618 2300 171 FORBES BLVD SUITE 1000 SE DECISION MADE: 29-NOV-13 MANSFIELD MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARPATH ALIGNER QSERVE AMERICA, INC. 510(k) NO: K123514(TRADITIONAL) ATTN: PATSY TRISLER PHONE NO : 301 652 5344 154 MAIN STREET, STE 2 SE DECISION MADE: 01-NOV-13 CHARLESTOWN NH 03603 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PETITE BASIC SYSTEM 701 ELT MEGO AFEK AC LTD 510(k) NO: K131420(TRADITIONAL) ATTN: MARIA GRIFFIN PHONE NO : 516 482 9001 55 NORTHERN BLVD., STE 200 SE DECISION MADE: 01-NOV-13 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SILK ROAD ACCESS CATHETER SILK ROAD MEDICAL, INC 510(k) NO: K130649(TRADITIONAL) ATTN: RICHARD M RUEDY PHONE NO : 408 720 9002 735 NORTH PASTORIA AVE SE DECISION MADE: 01-NOV-13 SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCANNING LASERLINK LUMENIS, INC. 510(k) NO: K130195(ABBREVIATED) ATTN: JACE R MCLANE PHONE NO : 801 656 2328 3959 WEST 1820 SOUTH SE DECISION MADE: 01-NOV-13 SALT LAKE CITY UT 84104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARFIL UNIVERSAL BOND VALUE PACK, CLEARFIL UNIVERSALY BOND TRIAL, CLEARFIL UNIVERSAL BOND KURARAY NORITAKE DENTAL INC. 510(k) NO: K132450(TRADITIONAL) ATTN: MICHIO TAKIGAWA PHONE NO : 813 67 011706 OTE CENTER BLDG 7F 1-1-3, OTEMACHISE DECISION MADE: 01-NOV-13 CHIYODA-KU JA 100-0004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUIET/SILENT SCANNING SUITE SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K132831(TRADITIONAL) ATTN: NADIA SOOKDEO PHONE NO : 610 448 4918 51 VALLEY STREAM PARKWAY SE DECISION MADE: 01-NOV-13 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERIMETER INTERBODY FUSION DEVICE MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K131669(TRADITIONAL) ATTN: LAUREN KAMER PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 01-NOV-13 Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAYSCAN A-EXPERT RAY CO., LTD 510(k) NO: K131693(SPECIAL) ATTN: ANDREW PAENG PHONE NO : 317 363 1000 4747 HOEN AVE. SE DECISION MADE: 01-NOV-13 SANTA ROSA CA 95405 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAYSCAN A-EXPERT 3D RAY CO., LTD 510(k) NO: K131695(SPECIAL) ATTN: ANDREW PAENG PHONE NO : 317 363 1000 4747 HOEN AVE. SE DECISION MADE: 01-NOV-13 SANTA ROSA CA 95405 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENAMELAST ULTRADENT PRODUCTS INC. / ORATECH 510(k) NO: K132109(TRADITIONAL) ATTN: KAREN KAKUNES PHONE NO : 801 553 4366 505 W 10200 S SE DECISION MADE: 01-NOV-13 SOUTH JORDAN UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KLARITY VACUUM BAG, KLARITY MOLD CUSHION KLARITY MEDICAL PRODUCTS, LLC 510(k) NO: K132124(TRADITIONAL) ATTN: PETER LARSON PHONE NO : 740 788 8107 80 WESTGATE DRIVE SE DECISION MADE: 01-NOV-13 NEWARK OH 43055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS) HEMODIA S.A.S. 510(k) NO: K132883(TRADITIONAL) ATTN: REMI TEULIERE PHONE NO : 33 561 007181 85 DU CHENE VERT SE DECISION MADE: 01-NOV-13 LABEGE FR 31670 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW
DEVICE: AMBU ASCOPE 3 5.0/2.2; AMBU ASCOPE 3 SLIM 3.8/1.2; AMBU AVIEW AMBU A/S 510(k) NO: K130845(TRADITIONAL) ATTN: SANJAY PARIKH PHONE NO : 410 768 6464 6740 BAYMEADOW DR. SE DECISION MADE: 01-NOV-13 GLEN BURNIE MD 21060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARIX HAND SYSTEM JEIL MEDICAL CORPORATION 510(k) NO: K131566(TRADITIONAL) ATTN: JI-EUN KIM PHONE NO : 82 2 8503500 #702, KOLON SCIENCE VALLEY 2ND 811SE DECISION MADE: 04-NOV-13 SEOUL-CITY KS 152-050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARES BOSTON SCIENTIFIC CORP. 510(k) NO: K131700(TRADITIONAL) ATTN: JANIS F TARANTO PHONE NO : 508 683 4560 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 04-NOV-13 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGHTHOUSE(TM) URINARY CATHETER SEEDINGS LIFE SCIENCE VENTURES, LL510(k) NO: K131655(TRADITIONAL) ATTN: KEN SOLOVAY PHONE NO : 954 336 0777 230 EAST 15TH STREET SUITE 1-A SE DECISION MADE: 04-NOV-13 NEW YORK NY 10003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WOLF LONG BONE PLATE SYSTEM TOBY ORTHOPAEDICS 510(k) NO: K131834(TRADITIONAL) ATTN: ERIC NEYHARD PHONE NO : 305 665 8699 401 SW 42nd Ave Suite 200 SE DECISION MADE: 04-NOV-13 Miami FL 33134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MECTACER BIOLOX OPTION HEADS MEDACTA INTERNATIONAL 510(k) NO: K131518(TRADITIONAL) ATTN: ADAM GROSS PHONE NO : 805 322 3289 4725 CALLE QUETZAL, UNIT B SE DECISION MADE: 04-NOV-13 CAMARILLO CA 93012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-PORTE ULTRASOUND SYSTEM FUJIFILM SONOSITE,INC. 510(k) NO: K133134(TRADITIONAL) ATTN: SCOTT PAULSON PHONE NO : 425 951 6926 21919 30th Dr SE SE DECISION MADE: 04-NOV-13 BOTHELL WA 98021 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW
DEVICE: CARDIOX FLOW DETECTION SYSTEM CARDIOX CORP. 510(k) NO: K122400(TRADITIONAL) ATTN: KAREN MATIS PHONE NO : 614 791 8118 4100 HORIZONS DRIVE, SUITE 100 SE DECISION MADE: 05-NOV-13 COLUMBUS OH 43220 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DICOMPACS DX-R WITH FLAT PANEL OEHM UND REHBEIN GMBH 510(k) NO: K131211(TRADITIONAL) ATTN: FRANZISKA GUENTHER PHONE NO : 49 38136 600500 NEPTUNALLEE 7C SE DECISION MADE: 05-NOV-13 ROCKSTOCK GM 18057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIDA LED SURGICAL LIGHTING SYSTEM CONVIDA HEALTHCARE & SYSTEMS CORPO510(k) NO: K132307(TRADITIONAL) ATTN: RYAN HUNG PHONE NO : 886 331837 77 2F AND B2, NO.33, DINGHU RD GUISHASE DECISION MADE: 05-NOV-13 TAOYUAN COUNTY TW 33378 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEMILLS VALVULOTOME LEMAITRE VASCULAR, INC. 510(k) NO: K132047(TRADITIONAL) ATTN: ANDREW HODGKINSON PHONE NO : 781 221 2266 63 SECOND AVENUE SE DECISION MADE: 05-NOV-13 BURLINGTON MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EM SINUS DILATION SYSTEM MEDTRONIC XOMED, INC. 510(k) NO: K132297(TRADITIONAL) ATTN: ROZANNE PACIEJ PHONE NO : 904 332 8233 6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 05-NOV-13 JACKSONVILLE FL 32216 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER SINGLE LUMEN, ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER DUAL LUMEN COVIDIEN 510(k) NO: K132567(SPECIAL) ATTN: DOLLY MISTRY PHONE NO : 508 452 1646 15 HAMPSHIRE STREET SE DECISION MADE: 05-NOV-13 MANSFIELD MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY, GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY – HIP, GRYPHON PEEK ANCHOR W/ PROKNOT T DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K132241(TRADITIONAL) ATTN: YAYORI FUJIMAKI PHONE NO : 508 828 3541 325 PARAMOUNT DR. SE DECISION MADE: 05-NOV-13 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NURO NEUROMODULATION SYSTEM ADVANCED URO-SOLUTIONS, INC. 510(k) NO: K132561(TRADITIONAL) ATTN: PENNY NORTHCUTT PHONE NO : 678 428 6978 717 LAKEGLEN DRIVE SE DECISION MADE: 05-NOV-13 SUWANEE GA 30024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFUSION SYRINGE SET INNOVATIVE MEDICAL MANUFACTURING C510(k) NO: K131661(TRADITIONAL) ATTN: LUCY HUANG PHONE NO : 011 886376 20236 107, LANE 181, SEC. 1 YONG JANE ROSE DECISION MADE: 05-NOV-13 CHUNAN, MIAOLI TW 350 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH COVIDIEN LLC 510(k) NO: K130357(TRADITIONAL) ATTN: KRISTEN SWANSON PHONE NO : 763 210 4062 161 CHESHIRE LANE STE 100 SE DECISION MADE: 06-NOV-13 MINNEAPOLIS MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET TELEFLEX MEDICAL 510(k) NO: K130405(TRADITIONAL) ATTN: LORI PFOHL PHONE NO : 919 491 8960 2917 WECK DR. SE DECISION MADE: 06-NOV-13 RESEARCH TRIANGLE PARK NC 27709 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM GENORAY CO., LTD. 510(k) NO: K130419(TRADITIONAL) ATTN: JAE KIM PHONE NO : 855 436 6729 1073 N. BATAVIA ST SE DECISION MADE: 06-NOV-13 ORANGE CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEMAITRE 8F OCCLUSION CATHETER LEMAITRE VASCULAR, INC. 510(k) NO: K132022(TRADITIONAL) ATTN: ANDREW HODGKINSON PHONE NO : 781 221 2266 63 2ND AVENUE SE DECISION MADE: 06-NOV-13 BURLINGTON MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET MOLNLYCKE HEALTH CARE US, LLC 510(k) NO: K132048(TRADITIONAL) ATTN: CURTIS D TRUESDALE PHONE NO : 678 250 7829 5550 PEACHTREE PARKWAY SUITE 500 SE DECISION MADE: 06-NOV-13 NORCROSS GA 30092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BELMONT HYPERTHERMIA PUMP BELMONT INSTRUMENT CORP. 510(k) NO: K131519(SPECIAL) ATTN: SABRINA BELLADUE PHONE NO : 978 663 0212 780 BOSTON RD. SE DECISION MADE: 06-NOV-13 BILLERICA MA 01821 510(k) STATEMENT
DEVICE: G-ARM MULTISCAN SYSTEM BEIJING EAST WHALE IMAGING TECHNOL510(k) NO: K131423(TRADITIONAL) ATTN: BETTER LI PHONE NO : 86 10678 92701-838 NO. 2 WORKSHOP BLDG 2, NO 9 KECHUASE DECISION MADE: 07-NOV-13 BEIJING CH 100023 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT COCHLEAR AMERICAS 510(k) NO: K131240(TRADITIONAL) ATTN: SEAN BUNDY PHONE NO : 800 523 5798 13059 EAST PEAKVIEW AVENUE SE DECISION MADE: 07-NOV-13 CENTENNIAL CO 80111 510(k) STATEMENT
DEVICE: CONCEIVE PLUS SASMAR INC 510(k) NO: K131355(TRADITIONAL) ATTN: JOHN-MICHAEL MANCINI PHONE NO : 773 942 0030 155 NORTH WACKER DR, STE 4250 SE DECISION MADE: 07-NOV-13 CHICAGO IL 60606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE KIMBERLY-CLARK CORP. 510(k) NO: K131841(TRADITIONAL) ATTN: CHRISTINE L MACAULEY PHONE NO : 770 587 8638 1400 HOLCOMB BRIDGE RD. SE DECISION MADE: 07-NOV-13 ROSWELL GA 30076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AQUILION ONE VISION, V6.0 TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K132222(TRADITIONAL) ATTN: PAUL BIGGINS PHONE NO : 714 669 7808 2441 MICHELLE DRIVE SE DECISION MADE: 07-NOV-13 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLARISO PACS CLARISO, INC. 510(k) NO: K132799(TRADITIONAL) ATTN: CARL ALLETTO PHONE NO : 469 684 1980 111 MELANIE DRIVE SE DECISION MADE: 07-NOV-13 AUBREY TX 76227 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DC 7 DC INTERNATIONAL, LLC 510(k) NO: K131839(TRADITIONAL) ATTN: DAVID BOEGLER PHONE NO : 561 337 8888 624 CYPRESS GREEN CIR. SE DECISION MADE: 07-NOV-13 WELLINGTON FL 33414 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASAPLP ASPIRATION CATHETER MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K132155(TRADITIONAL) ATTN: SUSAN CHRISTENSEN PHONE NO : 801 208 4789 1600 WEST MERIT PKWY. SE DECISION MADE: 07-NOV-13 SOUTH JORDAN UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHOALIGN PLUS SYSTEM ORTHALIGN, INC 510(k) NO: K130387(TRADITIONAL) ATTN: AMY WALTERS PHONE NO : 949 923 9400 338 VISTA MADERA SE DECISION MADE: 08-NOV-13 NEWPORT BEACH CA 92660 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K-Y BRAND LIQUIBEADS JOHNSON & JOHNSON HEALTHCARE PRODU510(k) NO: K122061(TRADITIONAL) ATTN: LORNA-JANE BREMER PHONE NO : 973 385 0557 185 TABOR ROAD SE DECISION MADE: 08-NOV-13 MORRIS PLAINS NJ 07950 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BYTECH BYTECH DONGTAI CO., LTD. 510(k) NO: K130101(TRADITIONAL) ATTN: CHU XIAOAN PHONE NO : 86 10 82387441 RM 1606 BUILDING 1 JIAN XIANG YUANSE DECISION MADE: 08-NOV-13 BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VOLUSON E6 / E8 / E8EXPERT / E8EXPERT LIMITED EDITION / E10 GE HEALTHCARE 510(k) NO: K132913(SPECIAL) ATTN: BRYAN BEHN PHONE NO : 414 721 4214 9900 W INNOVATION DRIVE SE DECISION MADE: 08-NOV-13 WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APNEALINK PRO RESMED GERMANY INC. 510(k) NO: K131932(TRADITIONAL) ATTN: SANDRA GRUNWALD PHONE NO : 49 899 90100 FRAUNHOFERSTRASSE 16 SE DECISION MADE: 08-NOV-13 MARTINSRIED GM D-82152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM ORTHOSENSOR, INC. 510(k) NO: K131767(SPECIAL) ATTN: MARTHA I GARAY PHONE NO : 954 577 7770 1855 GRIFFIN ROAD SUITE A-310 SE DECISION MADE: 08-NOV-13 DANIA BEACH FL 33004 2200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PASS LP SPINAL SYSTEM MEDICREA INTERNATIONAL 510(k) NO: K132574(TRADITIONAL) ATTN: AUDREY VION PHONE NO : 33 47 2018787 14 Porte du Grand Lyon SE DECISION MADE: 08-NOV-13 NEYRON FR 01700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDIVALVE ACWIRE MEDIVALVE LTD. 510(k) NO: K132545(TRADITIONAL) ATTN: LEO BASTA PHONE NO : 617 834 9866 93 BENEFIT STREET SE DECISION MADE: 08-NOV-13 PROVIDENCE RI 02904 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HUMELOCK II CEMENTLESS SHOULDER SYSTEM FX SOLUTIONS 510(k) NO: K130759(TRADITIONAL) ATTN: JEAN-JACQUES MARTIN PHONE NO : 33 474 553555 1663 RUE DE MAJORNAS SE DECISION MADE: 09-NOV-13 VIRIAT FR 01440 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAYMAN MI PLATE SYSTEM K2M, INC. 510(k) NO: K131533(TRADITIONAL) ATTN: NANCY GIEZEN PHONE NO : 703 777 3155 751 MILLER DR., S.E., SUITE F1 SE DECISION MADE: 09-NOV-13 Leesburg VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPECTRUM SPINE SPINOUS PROCESS DEVICE SPECTRUM SPINE IP HOLDINGS, LLC 510(k) NO: K130066(TRADITIONAL) ATTN: RICH JANSEN PHONE NO : 612 281 5505 13540 GUILD AVE SE DECISION MADE: 12-NOV-13 APPLE VALLEY MN 55124 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHANGHAI PHOENIX MECHANICAL WHEELCHAIR SHANGHAI PHOENIX MEDICAL EQUIPMENT510(k) NO: K130848(TRADITIONAL) ATTN: KE-MIN JEN PHONE NO : 86 216722 1555 No.188, Zhongfa Road Zhujing IndusSE DECISION MADE: 12-NOV-13 Jinshan District, Shanghai CN 2510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-CONTACT INFRARED THERMOMETER SHENZHEN JUMPER MEDICAL EQUIPMENT 510(k) NO: K131243(TRADITIONAL) ATTN: FIELD FU PHONE NO : 86 755 86069197 4TH FLOOR, JINHUI BLDG, NANHAI BLVSE DECISION MADE: 12-NOV-13 SHENZHEN, GUANGDON CH 518052 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I RUNE (I-200L) MEDIRUNE CO, LTD 510(k) NO: K122410(TRADITIONAL) ATTN: YANG HO DONG PHONE NO : 082 256633 60 821 SAMIL PLAZA 837-26 YEUKSAM-DONSE DECISION MADE: 12-NOV-13 GANGNAM-GU KS 135-768 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOGRAPH MMR SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K133226(SPECIAL) ATTN: NADIA SOOKDEO PHONE NO : 610 448 4918 51 VALLEY STREAM PKWY. SE DECISION MADE: 12-NOV-13 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFINIX ANGIO WORKSTATION W/DTS SOFTWARE TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K132106(TRADITIONAL) ATTN: PAUL BIGGINS PHONE NO : 714 669 7808 2441 MICHELLE DR. SE DECISION MADE: 12-NOV-13 TUSTIN CA 92780 2068 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GALAXY AND GALAXY+PLUS DIGITAL RADIOGRAPHY SYSTEMS RADIOLOGY SOLUTIONS LLC 510(k) NO: K132294(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 239 234 1735 8870 RAVELLO CT SE DECISION MADE: 12-NOV-13 NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUADROX-IR ADULT AND SMALL ADULT MAQUET CARDIOPULMONARY AG 510(k) NO: K133265(SPECIAL) ATTN: WHITNEY TORNING PHONE NO : 973 709 7994 45 BARBOUR POND DRIVE SE DECISION MADE: 12-NOV-13 WAYNE NJ 07470 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BECE CAD ZIRKON HT+ BEGO BREMER GOLDSCHLAEGEREI WILH. 510(k) NO: K132102(TRADITIONAL) ATTN: HEIKE GUSTKE PHONE NO : 49 421 2028112 WILHELM-HERBST-STRASSE 1 SE DECISION MADE: 12-NOV-13 BREMEN GM 28359 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONTAINER, 1000 ML HOSPIRA, INC. 510(k) NO: K132276(TRADITIONAL) ATTN: ABIGAIL FERGUSON PHONE NO : 224 212 6162 275 NORTH FIELD DR. SE DECISION MADE: 12-NOV-13 LAKE FOREST IL 60045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KULAVAC CGBIO CO., LTD 510(k) NO: K122490(TRADITIONAL) ATTN: JUNGEUN IM PHONE NO : 822 205 91675 163-3 SAMSUNG-DONG KANGNAM-GU SE DECISION MADE: 13-NOV-13 SEOUL KS 135-715 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IDYS(TM) C CLARIANCE 510(k) NO: K130853(TRADITIONAL) ATTN: JANICE M HOGAN PHONE NO : 267 675 4611 1835 MARKET STREET 29TH FLOOR SE DECISION MADE: 13-NOV-13 PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPACE CHAMBER PLUS COMPACT SPACE CHAMBER PLUS MEDICAL DEVELOPMENTS INTERNATIONAL510(k) NO: K122252(TRADITIONAL) ATTN: TRACEY BULLIVANT PHONE NO : 612 990 62984 SUITE 408, 460 PACIFIC HIGHWAY SE DECISION MADE: 13-NOV-13 ST LEONARDS AS 2065 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA DOUBLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SA AMERIWATER 510(k) NO: K131904(TRADITIONAL) ATTN: BRIAN R BOWMAN PHONE NO : 937 461 8833 1303 STANLEY AVE. SE DECISION MADE: 13-NOV-13 DAYTON OH 45404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: U&U STERILE HYPODERMIC NEEDLE U&U MEDICAL TECHNOLOGY CO., LTD 510(k) NO: K132552(TRADITIONAL) ATTN: XUEBO WANG PHONE NO : 86 1356 4751751 DONGZHOU VILLAGE, HENGSHANQIAO SE DECISION MADE: 13-NOV-13 CHANGZHOU, JIANGSU CH 213119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B BECTON DICKINSON & CO. 510(k) NO: K133138(SPECIAL) ATTN: GREGORY P PAYNE PHONE NO : 858 795 7890 10865 ROAD TO THE CURE, SUITE 200 SE DECISION MADE: 13-NOV-13 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MERIDIAN AB ARDENT 510(k) NO: K131753(ABBREVIATED) ATTN: DONNA MARIE HARTNETT PHONE NO : 716 691 0010 175 PINEVIEW DRIVE SE DECISION MADE: 14-NOV-13 AMHERST NY 14228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOSCH BLOOD PRESSURE METER (BP5000 BT) ROBERT BOSCH HEALTHCARE SYSTEMS, I510(k) NO: K131026(TRADITIONAL) ATTN: LOUISE MUSANTE PHONE NO : 650 690 9167 2400 Geng Rd Ste 200 SE DECISION MADE: 14-NOV-13 Palo Alto CA 94303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL ELECTROCARDIOGRAPHS SONOSCAPE COMPANY LIMITED 510(k) NO: K131262(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 86 21 22815850 P.O. BOX 120-119 SE DECISION MADE: 14-NOV-13 SHANGHAI CH 237-023 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANKER DENTAL IMPLANT SYSTEM ALLIANCE GLOBAL 510(k) NO: K131165(TRADITIONAL) ATTN: YAYUAN CHANG PHONE NO : 866 7695 6688 2F., NO.92, LUKE 5TH RD., LUZHU DISE DECISION MADE: 14-NOV-13 KAOHSIUNG CITY TW 82151 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PEREGRINE CURVED ILLUMINATING LASER PROBE PEREGRINE SURGICAL, LTD. 510(k) NO: K132614(SPECIAL) ATTN: RYAN O’LEARY PHONE NO : 215 348 0456 51 Britain Drive SE DECISION MADE: 14-NOV-13 Doylestown PA 18901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT MAQUET CARDIOVASCULAR LLC 510(k) NO: K131778(TRADITIONAL) ATTN: MARYLOU INSINGA PHONE NO : 973 709 7442 45 BARBOUR POND DRIVE SE DECISION MADE: 14-NOV-13 Wayne NJ 07470 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM BOSTON SCIENTIFIC CORP. 510(k) NO: K133208(SPECIAL) ATTN: MAUREEN SUNDEEN PHONE NO : 763 494 2903 ONE SCIMED PLACE SE DECISION MADE: 14-NOV-13 MAPLE GROVE MN 55311 1566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DOSIMETRY CHECK VERSION 4 RELEASE 1 MATH RESOLUTIONS, LLC. 510(k) NO: K132605(TRADITIONAL) ATTN: WENDEL DEAN RENNER PHONE NO : 410 997 9578 5975 GALES LN. SE DECISION MADE: 14-NOV-13 COLUMBIA MD 21045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL COLOR DOPPLER ULTASOUND SYSTEM SONOSCAPE COMPANY LIMITED 510(k) NO: K132527(TRADITIONAL) ATTN: TOKI WU PHONE NO : 86 755267 22890 YIZHE BLDG., YUQUAN RD SE DECISION MADE: 14-NOV-13 SHENZHEN, GUANGDONG CH 518051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IQ IMPLANTS; IQ IMPLANTS; IQ IMPLANTS ABUTMENTS IQ IMPLANTS LTD. 510(k) NO: K130829(TRADITIONAL) ATTN: NATALIA DINERSTHEIN PHONE NO : 972 8 6233568 TAASHUR 9 SE DECISION MADE: 14-NOV-13 OMER IS 84965 510(k) STATEMENT
DEVICE: MAGNETOM AERA SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K132951(SPECIAL) ATTN: NADIA SOOKDEO PHONE NO : 610 448 4918 51 VALLEY STREAM PARKWAY SE DECISION MADE: 15-NOV-13 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPM-300 BIONET CO., LTD. 510(k) NO: K130322(TRADITIONAL) ATTN: MARC GOODMAN PHONE NO : 949 398 5222 5405 ALTON PARKWAY, SUITE A530 SE DECISION MADE: 15-NOV-13 IRVINE CA 92604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYMPHONY RF GENERATOR THERMIGEN, INC. 510(k) NO: K130689(TRADITIONAL) ATTN: KEVIN O’BRIEN PHONE NO : 214 621 2525 401 N. CARROLL AVE SE DECISION MADE: 15-NOV-13 SOUTHLAKE TX 76092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEOVEIL GUNZE LIMITED 510(k) NO: K130997(TRADITIONAL) ATTN: NOBUYA ONISHI PHONE NO : 817 734280 35 46 NATSUMEGAICHI, AONO SE DECISION MADE: 15-NOV-13 AYABE, KYOTO JA 623-8513 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOLITH TOUCH; URO TOUCH NORTHGATE TECHNOLOGIES INC. 510(k) NO: K130368(TRADITIONAL) ATTN: CASEY KUREK PHONE NO : 224 856 2222 1591 Scottsdale Court SE DECISION MADE: 15-NOV-13 Elgin IL 60123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANSGATE GUIDE CATHETER STRYKER NEUROVASCULAR 510(k) NO: K132542(TRADITIONAL) ATTN: ANJALI ATAL-GUPTA PHONE NO : 510 413 2500 47900 BAYSIDE PARKWAY SE DECISION MADE: 15-NOV-13 FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTRONIC PULSE MASSAGER SHENZHEN JINGKEHUI ELECTRONIC CO.,510(k) NO: K131921(TRADITIONAL) ATTN: BILL DAI PHONE NO : 508 723 6334 513 PIAZZA DR. UNIT B SE DECISION MADE: 15-NOV-13 MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHARPSOLOGY 2 INDUSTRIAL WATER SOLUTIONS, INC. 510(k) NO: K133031(TRADITIONAL) ATTN: THOMAS P STEWART PHONE NO : 540 520 6341 2692 WILLOWLAWN STREET, S.W. SE DECISION MADE: 15-NOV-13 Roanoke VA 24018 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW
DEVICE: DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T GE HEALTHCARE (GE MEDICAL SYSTEMS,510(k) NO: K132376(TRADITIONAL) ATTN: MICHELLE HUETTNER PHONE NO : 262 521 6102 3200 N. GRANDVIEW BLVD SE DECISION MADE: 15-NOV-13 WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ND NABIL DIB INFUSION CATHETER TRANSLATIONAL RESEARCH INSTITUTE 510(k) NO: K130569(TRADITIONAL) ATTN: DEANN DANA PHONE NO : 480 612 0640 3420 S MERCY RD #312 SE DECISION MADE: 15-NOV-13 GILBERT AZ 85297 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV BECTON DICKINSON & CO. 510(k) NO: K133140(SPECIAL) ATTN: GREGORY P PAYNE PHONE NO : 858 795 7890 10865 ROAD TO THE CURE, SUITE 200 SE DECISION MADE: 15-NOV-13 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROCYN SCAR MANAGEMENT HYDROGEL OCULUS INNOVATIVE SCIENCES 510(k) NO: K131672(TRADITIONAL) ATTN: BRIAN W MARTIN PHONE NO : 707 283 0550 1129 N MCDOWELL BLVD SE DECISION MADE: 15-NOV-13 PETALUMA CA 94954 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TENSYN BAND DALLEN MEDICAL, INC. 510(k) NO: K131850(TRADITIONAL) ATTN: AL MEMMOLO PHONE NO : 949 218 0030 1046 Calle Recodo Ste G SE DECISION MADE: 15-NOV-13 San Clemente CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VOLCANO LOMAP,VOLCANO LOMAP OPTION KIT FOR MOBILE SYSTEM,VOLCANO LOMAP OPTION FOR INTEGRATED SYSTEM,VOLCANO S5 PRECISION VOLCANO CORPORATION 510(k) NO: K133142(SPECIAL) ATTN: ELAINE ALAN PHONE NO : 978 439 3357 1 FORTUNE DR SE DECISION MADE: 15-NOV-13 BILLERICA MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V.A.C. VIA NEGATIVE PRESSURE WOUND THERAPY SYSTEM KCI USA, INC. 510(k) NO: K132741(SPECIAL) ATTN: MELANIE AVILA PHONE NO : 210 515 4059 6203 FARINON DR. SE DECISION MADE: 15-NOV-13 SAN ANTONIO TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS) GE MEDICAL SYSTEMS, LLC 510(k) NO: K132261(TRADITIONAL) ATTN: JOHN L SCHMIDT PHONE NO : 262 548 4964 3000 N GRANDVIEW BLVD. SE DECISION MADE: 18-NOV-13 WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTEGRITY SPINE CORE SYSTEM INTEGRITY SPINE 510(k) NO: K132718(TRADITIONAL) ATTN: LISA PETERSON PHONE NO : 512 507 0746 14001 HUNTERS PASS SE DECISION MADE: 18-NOV-13 AUSTIN TX 78734 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIVISE SPINOUS PROCESS FIXATION PLATE (35MM, 40MM) STRYKER SPINE 510(k) NO: K132968(TRADITIONAL) ATTN: KRISTEN MEANY, MS, CQA, RACPHONE NO : 201 760 8070 2 PEARL COURT SE DECISION MADE: 18-NOV-13 ALLENDALE NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTEGRA FACET FIXATION SYSTEM SEASPINE, INC. 510(k) NO: K132859(TRADITIONAL) ATTN: MICHELLE WILLIS PHONE NO : 760 216 5104 2302 LA MIRADA DR. SE DECISION MADE: 18-NOV-13 VISTA CA 92081 7862 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOQTEQ HIGH TIBIA OSTEOTOMY PLATE 4.5 AAP IMPLANTATE AG 510(k) NO: K131782(TRADITIONAL) ATTN: CHRISTIAN ZIETSCH PHONE NO : 49 307501 9193 LORENZWEG 5 SE DECISION MADE: 18-NOV-13 BERLIN GM 12099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLOWER ANKLE PLATING SET FLOWER ORTHOPEDICS CORPORATION 510(k) NO: K133102(TRADITIONAL) ATTN: JANICE M HOGAN PHONE NO : 267 675 4611 1835 MARKET ST, 29TH FLOOR SE DECISION MADE: 18-NOV-13 PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT ARTHROSURFACE, INC. 510(k) NO: K131377(TRADITIONAL) ATTN: DAWN J WILSON PHONE NO : 508 520 3003 28 FORGE PARKWAY SE DECISION MADE: 19-NOV-13 FRANKLIN MA 02038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUMITOMO PROTON THERAPY SYSTEM SUMITOMO HEAVY INDUSTRIES, LTD 510(k) NO: K130426(TRADITIONAL) ATTN: RONALD S WARREN PHONE NO : 858 753 1961 11440 W. BERNARDO COURT SUITE 300 SE DECISION MADE: 19-NOV-13 SAN DIEGO CA 92127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PARACE MD EKOSCOPE IS100 PARACE LLC 510(k) NO: K123148(TRADITIONAL) ATTN: VANDETTE CARTER PHONE NO : 914 356 4848 PO BOX 171 SE DECISION MADE: 19-NOV-13 YORKTOWN HEIGHTS NY 10598 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM ZIMMER DENTAL INC. 510(k) NO: K132258(TRADITIONAL) ATTN: JULIE L CORMAN PHONE NO : 760 929 4300 1900 ASTON AVE. SE DECISION MADE: 19-NOV-13 CARLSBAD CA 92008 7308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER MEDTRONIC INC. 510(k) NO: K132712(TRADITIONAL) ATTN: LISA STONE PHONE NO : 763 514 9866 8200 CORAL SEA STREET NE SE DECISION MADE: 19-NOV-13 MOUNDS VIEW MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DC-N2/DC-N2S DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K132779(TRADITIONAL) ATTN: PHONE NO : MINDRAY BLDG. KEJI 12TH RD S. HI-TSE DECISION MADE: 19-NOV-13 NANSHAN, SHENZHEN CH 518057 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW
DEVICE: V.A.C. GRANUFOAM DRESSING, GRANUFOAM THIN DRESSING, GRANUFOAM ROUND DRESSING, GRANUFOAM SILVER DRESSING, WHITEFOAM DRESS KCI USA, INC. 510(k) NO: K133276(SPECIAL) ATTN: MELANIE AVILA PHONE NO : 210 515 4059 6203 FARINON DR. SE DECISION MADE: 19-NOV-13 SAN ANTONIO TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A.L.P.S. CALCANEAL PLATING SYSTEM BIOMET MANUFACTURING CORP. 510(k) NO: K132898(TRADITIONAL) ATTN: JARED COOPER PHONE NO : 574 372 1941 56 EAST BELL DRIVE P.O. BOX 587 SE DECISION MADE: 19-NOV-13 WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGE WUXI YUSHOU MEDICAL APPLICANCES CO510(k) NO: K130212(TRADITIONAL) ATTN: GARFIELD WANG PHONE NO : 86 510 83777555 215# XIGANG ROAD DONGBEITANG SE DECISION MADE: 20-NOV-13 WUXI CITY, JINGSU CH 214191 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISIRONA MAGELLAN ISIRONA, LLC 510(k) NO: K130707(TRADITIONAL) ATTN: THOMAS KROENKE PHONE NO : 303 956 4232 PO BOX 3018 SE DECISION MADE: 20-NOV-13 NEDERLAND CO 80466 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERILE PISTON HYPODERMIC SYRINGES (WITH/WITHOUT NEEDLE), HYPODERMIC NEEDLES WUXI YUSHOU MEDICAL APPLICANCES CO510(k) NO: K130230(TRADITIONAL) ATTN: GARFIELD WANG PHONE NO : 86 510 83777555 215# XIGANG ROAD DONGBEITANG SE DECISION MADE: 20-NOV-13 WUXI CITY, JIANGSU CH 214191 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HAMILTON-MR1 HAMILTON MEDICAL AG 510(k) NO: K122438(ABBREVIATED) ATTN: RALPH AGUILA PHONE NO : 418 166 06845 VIA CRUSCH 8 SE DECISION MADE: 20-NOV-13 BONADUZ SZ CH-7402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WRIGHT GRADIENT 52 – TORSO WRIGHT THERAPY PRODUCTS, INC 510(k) NO: K131387(TRADITIONAL) ATTN: CAROL WRIGHT PHONE NO : 800 631 9535 103-B INTERNATIONAL DR. SE DECISION MADE: 20-NOV-13 OAKDALE PA 15071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MRI MARKER C4 IMAGING LLC 510(k) NO: K131689(TRADITIONAL) ATTN: STEPHEN J GOLDNER, JD, RAC PHONE NO : 248 747 8008 2550 SOUTH TELEGRAPH ROAD SUITE 10SE DECISION MADE: 20-NOV-13 BLOOMFIELD HILLS MI 48302 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONACO IMPAC MEDICAL SYSTEMS, INC. 510(k) NO: K132971(TRADITIONAL) ATTN: KATHRYN STINSON PHONE NO : 314 993 0003 13723 Riverport Drive Suite 100 SE DECISION MADE: 20-NOV-13 Maryland Heights MO 63139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APEX SPINE SYSTEM SPINECRAFT LLC 510(k) NO: K132603(TRADITIONAL) ATTN: AMI AKALLAL-ASAAD PHONE NO : 630 920 7300 777 OAKMONT LANE SE DECISION MADE: 20-NOV-13 WESTMONT IL 60559 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRONCHOSCOPY ELBOW RESPIRONICS, INC. 510(k) NO: K132168(TRADITIONAL) ATTN: COLLEEN WITT PHONE NO : 724 387 4146 365 PLUM INDUSTRIAL COURT SE DECISION MADE: 20-NOV-13 PITTSBURGH PA 15239 510(k) STATEMENT
DEVICE: I2C ION BEAM APPLICATIONS S.A. 510(k) NO: K132847(TRADITIONAL) ATTN: BRUCE D ARMON PHONE NO : 215 972 7124 1500 MARKET STREET CENTRE SQUARE WSE DECISION MADE: 20-NOV-13 PHILADELPHIA PA 19102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BNX DELIVERY SYSTEM PRE-LOADED WITH 19, 22 AND 25 GAUGE NEEDLE, 19, 22 OR 25 GAUGE NEEDLES (INDIVIDUALLY STERILE-PACKED, BEACON ENDOSCOPIC 510(k) NO: K133008(TRADITIONAL) ATTN: ANNETTE M FAGNANT PHONE NO : 617 965 7111 2000 Commonwealth Ave Ste 110 SE DECISION MADE: 20-NOV-13 Auburndale MA 02466 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTICAM 3000 ECO INTER MEDICAL MEDIZINTECHNIK GMBH 510(k) NO: K132347(TRADITIONAL) ATTN: WILLIAM CARROLL PHONE NO : 203 483 0665 14 COMMERCIAL ST, UNIT B SE DECISION MADE: 20-NOV-13 BRANFORD CT 06405 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RETROARC RETROPUBIC SLING SYSTEM AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K132655(TRADITIONAL) ATTN: RENEE MELLUM PHONE NO : 952 930 6458 10700 BREN RD., WEST SE DECISION MADE: 20-NOV-13 MINNETONKA MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR WELCH ALLYN, INC. 510(k) NO: K132808(SPECIAL) ATTN: KEVIN CROSSEN PHONE NO : 315 685 2609 4341 STATE ST. RD. P.O. BOX 220 SE DECISION MADE: 20-NOV-13 SKANEATELES FALLS NY 13153 0220 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AGAMATRIX HEALTH MANAGER AGAMATRIX INC 510(k) NO: K132821(SPECIAL) ATTN: WILLIAM H MCGRAIL PHONE NO : 603 328 6051 7C RAYMOND AVE SE DECISION MADE: 20-NOV-13 SALEM NH 03079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NMI PICC III NAVILYST MEDICAL, INC. 510(k) NO: K133264(SPECIAL) ATTN: BRANDON BRACKETT PHONE NO : 508 658 7984 26 FOREST STREET SE DECISION MADE: 20-NOV-13 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EDGE ORTHOPAEDICS BITE COMPRESSION SCREW ICON ORTHOPAEDIC CONCEPTS DBA EDGE510(k) NO: K132893(TRADITIONAL) ATTN: JAN TRIANI PHONE NO : 201 543 9388 6 MARS COURT UNIT 6-3 SE DECISION MADE: 20-NOV-13 BOONTON NJ 07005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVEREST SPINAL SYSTEM K2M, INC. 510(k) NO: K132757(TRADITIONAL) ATTN: NANCY GIEZEN PHONE NO : 703 777 3155 751 MILLER DR.,SE SE DECISION MADE: 20-NOV-13 LEESBURG VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AFFIX II SPINOUS PROCESS PLATE SYSTEM NUVASIVE, INCORPORATED 510(k) NO: K132411(TRADITIONAL) ATTN: OLGA LEWIS PHONE NO : 858 320 5257 7475 LUSK BOULEVARD SE DECISION MADE: 20-NOV-13 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRT AUDIFON-USA INC. 510(k) NO: K130514(ABBREVIATED) ATTN: JANE E PERRONE PHONE NO : 386 668 8812 403 CHAIRMAN COURT, STE. 1 SE DECISION MADE: 21-NOV-13 DEBARY FL 32713 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE PERSYST DEVELOPMENT CORP. 510(k) NO: K132306(TRADITIONAL) ATTN: DARI DARABBEIGI PHONE NO : 858 461 4542 12625 HIGH BLUFF DRIVE SUITE 213 SE DECISION MADE: 21-NOV-13 SAN DIEGO CA 92130 510(k) STATEMENT
DEVICE: MALDI BIOTYPER CA (MBT-CA) SYSTEM BRUKER DALTONICS, INC 510(k) NO: K130831(TRADITIONAL) ATTN: FRAN WHITE PHONE NO : 978 927 3808 180 CABOT STREET SE DECISION MADE: 21-NOV-13 BEVERLY MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PC ECG EDAN INSTRUMENTS, INC. 510(k) NO: K131819(TRADITIONAL) ATTN: QUEENA CHEN PHONE NO : 867 55 26858736 EQUIPMENTS PARK, NANHAI RD 1019 NOSE DECISION MADE: 22-NOV-13 SHENZHEN CH 518067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REDSENSE ALARM SYSTEM REDSENSE MEDICAL AB 510(k) NO: K130554(TRADITIONAL) ATTN: PATRIK BYHMER PHONE NO : 49 7035 72164 GYLLENHAMMARS VAG 26 SE DECISION MADE: 22-NOV-13 HALMSTAD SW 30292 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BREATH SHAKE CHEEN HOUNG ENT. CO. LTD. 510(k) NO: K121587(TRADITIONAL) ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSAGE DRIVE SE DECISION MADE: 22-NOV-13 BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OTOMAG BONE CONDUCATION HEARING SYSTEM SOPHONO, INC 510(k) NO: K132189(TRADITIONAL) ATTN: KRISTA B TRAYNOR PHONE NO : 720 407 5160 5744 CENTRAL AVENUE #100 SE DECISION MADE: 22-NOV-13 BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PIEZON 150 E.M.S. ELECTRO MEDICAL SYSTEMS S.A510(k) NO: K132443(SPECIAL) ATTN: CYNTHIA NOLTE PHONE NO : 919 859 4207 62 FOREST ST., STE 300 SE DECISION MADE: 22-NOV-13 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADHESIVE ELECTRODES TOP-RANK HEALTH CARE EQUIPMENT CO.510(k) NO: K132588(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 86 21 22815850 P.O. BOX 120-119 SE DECISION MADE: 22-NOV-13 SHANGHAI CH 200120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOFIA DISTAL ACCESS CATHETER MICRO VENTION, INC. 510(k) NO: K131482(TRADITIONAL) ATTN: NAOMI GONG PHONE NO : 714 247 8000 1311 VALENCIA AVENUE SE DECISION MADE: 22-NOV-13 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V8 TRANSLUMINAL BAV CATHETER INTERVALVE, INC 510(k) NO: K132728(SPECIAL) ATTN: SEW-WAH TAY PHONE NO : 612 801 6782 84801 73RD AVENUE NORTH, SUITE 63 SE DECISION MADE: 22-NOV-13 MINNEAPOLIS MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SP-FIX SPINOUS PROCESS FIXATION PLATE GLOBE MEDICAL, INC. 510(k) NO: K132191(TRADITIONAL) ATTN: CHRISTINA KICHULA PHONE NO : 610 930 1800 2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 22-NOV-13 AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECSYS CK-MB CALCHECK 5 ROCHE DIAGNOSTICS 510(k) NO: K133284(TRADITIONAL) ATTN: KELLI TURNER PHONE NO : 317 521 4515 9115 HAGUE ROAD SE DECISION MADE: 22-NOV-13 INDIANAPOLIS IN 46250 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRESCENT SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K133216(SPECIAL) ATTN: ANKIT K SHAH PHONE NO : 800 876 3133 1800 PYRAMID PLACE SE DECISION MADE: 22-NOV-13 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V-STICK VASCULAR ACCESS SET ARGON MEDICAL 510(k) NO: K130730(SPECIAL) ATTN: JENNIFER BONACCI PHONE NO : 352 519 5029 3600 SW 47TH AVE SE DECISION MADE: 22-NOV-13 GAINESVILLE FL 32608 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSE-4BABY SYSTEM SENSE4BABY, INC. 510(k) NO: K132918(TRADITIONAL) ATTN: JACQUES GINESTET PHONE NO : 858 412 8605 3344 N. TORREY PINES COURT, STE 10SE DECISION MADE: 22-NOV-13 LA JOLLA CA 92037 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW
DEVICE: EASYCARE ONLINE RESMED LTD. 510(k) NO: K132371(TRADITIONAL) ATTN: JIM CASSI PHONE NO : 858 836 6081 9001 SPECTRUM CENTER BLVD. SE DECISION MADE: 22-NOV-13 SAN DIEGO CA 92123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLARITY LPC LASER SYSTEM LUTRONIC CORPORATION 510(k) NO: K130199(TRADITIONAL) ATTN: JHUNG WON VOJIR PHONE NO : 215 205 2219 6 NESHAMINY INTERPLEX, SUITE 207 SE DECISION MADE: 22-NOV-13 TREVOSE PA 19053 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNETOM PRISMA, MAGNETOM PRISMA FIT SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K132119(TRADITIONAL) ATTN: NADIA SOOKDEO PHONE NO : 610 448 4918 51 VALLEY STREAM PKWY. SE DECISION MADE: 22-NOV-13 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOPTOUCH /OTHER CLIENTS PRIVATE LABELING JIANGSU TOPTOUCH GLOVE CO., LTD. 510(k) NO: K131826(TRADITIONAL) ATTN: CHU XIAOAN PHONE NO : 86 10 82387441 RM 1606 BLDG, 1 JIAN XIANG YUAN NOSE DECISION MADE: 22-NOV-13 BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM CARDIOVASCULAR SYSTEMS INCORPORATE510(k) NO: K133399(SPECIAL) ATTN: BLAIR BUTH PHONE NO : 651 259 2032 651 CAMPUS DR. SE DECISION MADE: 22-NOV-13 SAINT PAUL MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DANA REUSABLE BI TEST PACK DANA PRODUCTS, INC. 510(k) NO: K130135(TRADITIONAL) ATTN: HARRY BALA PHONE NO : 847 455 2881 7 COREY DR. SE DECISION MADE: 25-NOV-13 SOUTH BARINGTON IL 60010 510(k) STATEMENT
DEVICE: CAPNOMASK MEDIPLUS LTD. 510(k) NO: K131339(TRADITIONAL) ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSAGE DRIVE SE DECISION MADE: 25-NOV-13 BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHREX COMPRESSION FT SCREWS ARTHREX, INC. 510(k) NO: K132217(TRADITIONAL) ATTN: COURTNEY SMITH PHONE NO : 239 643 5553 1370 CREEKSIDE BOULEVARD SE DECISION MADE: 25-NOV-13 NAPLES FL 34108 1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLACK COLOURED CONDOM KAREX INDUSTRIES SDN BHD 510(k) NO: K132597(ABBREVIATED) ATTN: MARY GOH YIN PHONE NO : 607 688 1800 PTD. 7906/7907, TAMAN PONTIAN JAYASE DECISION MADE: 25-NOV-13 PONTIAN, JOHOR MY 82000 510(k) STATEMENT
DEVICE: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K132639(TRADITIONAL) ATTN: SHWETA SHARMA PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 25-NOV-13 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VAULT-C INTERVERTEBRAL BODY FUSION DEVICE EMPIRICAL TESTING CORPORATION 510(k) NO: K132029(TRADITIONAL) ATTN: MEREDITH MAY PHONE NO : 719 264 9937 4628 NORTHPARK DRVE SE DECISION MADE: 25-NOV-13 COLORADO SPRINGS CO 80918 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIA / VITALITY ANALYZER IPGDX, LLC 510(k) NO: K130856(TRADITIONAL) ATTN: KEVIN WALLS PHONE NO : 720 962 5412 33 GOLDEN EAGLE LANE SE DECISION MADE: 25-NOV-13 LITTLETON CO 80127 510(k) STATEMENT
DEVICE: INBODY BIOSPACE CORPORATION LIMITED 510(k) NO: K130777(TRADITIONAL) ATTN: DANIEL KAMM, P.E. PHONE NO : 239 234 1735 8870 RAVELLO CT SE DECISION MADE: 25-NOV-13 NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM ZIMMER SPINE, INC. 510(k) NO: K132884(TRADITIONAL) ATTN: JONATHAN GILBERT PHONE NO : 952 830 6385 7375 BUSH LAKE RD. SE DECISION MADE: 25-NOV-13 MINNEAPOLIS MN 55439 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANAX 5.5 SPINAL SYSTEM U & I CORPORATION 510(k) NO: K132101(TRADITIONAL) ATTN: YOUNG-GEUN KIM PHONE NO : 82 31 8520102 20, SANDAN-RO, 76BEON-GIL (RD) SE DECISION MADE: 25-NOV-13 UIJEONGBU-SI, GYEONGGI-DO KS 48510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM CORELINK LLC 510(k) NO: K132504(TRADITIONAL) ATTN: JUSTIN EGGLETON PHONE NO : 202 552 5800 1331 H STREET NW, 12TH FLOOR SE DECISION MADE: 25-NOV-13 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA TOMTEC IMAGING SYSTEMS, GMBH 510(k) NO: K132544(TRADITIONAL) ATTN: CHRISTINE KLEIN PHONE NO : 49 893217 5830 EDISONSTRASSE 6 SE DECISION MADE: 25-NOV-13 UNTERSCHLEISSHEIM GM D-85716 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FDR D-EVO FLAT PANEL DETECTOR SYSTEM FUJIFILM MEDICAL SYSTEMS USA, INC.510(k) NO: K132509(TRADITIONAL) ATTN: KATHERINE Y CHOI PHONE NO : 203 602 3568 419 WEST AVENUE SE DECISION MADE: 25-NOV-13 STAMFORD CT 06902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHARRUAPACS SYSTEM CHARRUASOFT SA 510(k) NO: K133357(TRADITIONAL) ATTN: CARL ALLETTO PHONE NO : 469 684 1980 111 MELANIE DRIVE SE DECISION MADE: 25-NOV-13 AUBREY TX 76227 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VALVED TEARAWAY INTRODUCER GENERATION II MEDCOMP (MEDICAL COMPONENTS, INC.)510(k) NO: K132498(SPECIAL) ATTN: TIMOTHY HOLWICK PHONE NO : 215 256 4201 1499 DELP DR. SE DECISION MADE: 25-NOV-13 HARLEYSVILLE PA 19438 510(k) STATEMENT
DEVICE: NEURODYN MULTIWAVE, AUSSIE SPORT IBRAMED EQUIPAMENTOS MEDICOS 510(k) NO: K131629(TRADITIONAL) ATTN: LILIAN LLULL PHONE NO : 305 377 0077 18851 NE 29TH AVE 720 SE DECISION MADE: 26-NOV-13 AVENTURA FL 33180 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM EXACTECH, INC. 510(k) NO: K131298(TRADITIONAL) ATTN: SHING JEN TAI, PHD PHONE NO : 352 377 1140 2320 N.W. 66TH CT. SE DECISION MADE: 26-NOV-13 GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPSMEDICAL SPORVIEW 10 STEAM SELF CONTAINED BIOLOGICAL INDICATOR SPS MEDICAL SUPPLY CORP. 510(k) NO: K122024(TRADITIONAL) ATTN: GARY J SOCOLA PHONE NO : 585 359 0130 6789 W Henrietta Rd SE DECISION MADE: 26-NOV-13 Industry NY 14543 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHASER V-MINI RX SHASER, INC. 510(k) NO: K132170(TRADITIONAL) ATTN: ANTHONY BURNS PHONE NO : 781 995 2246 10 MAGUIRE ROAD SE DECISION MADE: 26-NOV-13 LEXINGTON MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLAX DONGGUAN PRESTIGE SPORTING GOODS C510(k) NO: K131302(TRADITIONAL) ATTN: JUNNATA CHANG PHONE NO : 886 4 22465396 16F-2(16A), NO. 462, SEC. 2 CHONGDSE DECISION MADE: 26-NOV-13 TAICHUNG TW 406 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC PHILIPS MEDIZIN SYSTEME BOEBLINGEN510(k) NO: K131913(ABBREVIATED) ATTN: MARKUS STACHA PHONE NO : 49 7031 4632840 HEWLETT-PACKARD STR. 2 SE DECISION MADE: 26-NOV-13 BOEBLINGEN, BW GM D-71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE INFUSION SET SHANGHAI JINTA MEDICAL CO., LTD 510(k) NO: K131646(TRADITIONAL) ATTN: WANG CHANGQING PHONE NO : 021 6736 1700 NO. 18, JIANDING ROAD SE DECISION MADE: 26-NOV-13 FENGJING TOWN, JINSHAN DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLVOES, LIGHT YELLOW COLOR JIANGSU HANDSAFE GLOVE CO., LTD. 510(k) NO: K131828(TRADITIONAL) ATTN: CHU XIAOAN PHONE NO : 86 10 82387441 ROOM 1606 BLDG 1, JIAN XIANG YUAN SE DECISION MADE: 26-NOV-13 BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR JIANGSU HEALTHCARE PRODUCTS CO., L510(k) NO: K131831(TRADITIONAL) ATTN: CHU XIAOAN PHONE NO : 86 10 82387441 ROOM 1606 BLDG 1, JIAN XIANG YUAN SE DECISION MADE: 26-NOV-13 BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CV3000 HOLTER ANALYSIS SYSTEM VALES & HILLS BIOMEDICAL TECH. LTD510(k) NO: K131897(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 86 21 22815850 P.O. BOX 120-119 SE DECISION MADE: 26-NOV-13 SHANGHAI CH 200120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMOTION ECG MOBILE MEGA ELECTRONICS LTD. 510(k) NO: K131699(TRADITIONAL) ATTN: ANDRE KINDSVATER PHONE NO : 31 70 3458570 PRINSESSEGRACHT 20 SE DECISION MADE: 26-NOV-13 THE HAGUE NL 2514 AP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIGIS RX N (MEDIUM), AIGIS RX N (LARGE) TYRX , INC. 510(k) NO: K132699(TRADITIONAL) ATTN: REGINA NOVAK PHONE NO : 732 964 1492 1 DEER PARK DR. SUITE G SE DECISION MADE: 26-NOV-13 MONMOUTH JUNCTION NJ 08852 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERITEC GREEN CARD PACK BOWIE-DICK TEST STERITEC PRODUCTS MFG. CO., INC. 510(k) NO: K132372(TRADITIONAL) ATTN: JONATHAN RUTIGLIANO PHONE NO : 303 660 4201 74 INVERNESS DRIVE EAST SE DECISION MADE: 26-NOV-13 ENGLEWOOD CO 80112 510(k) STATEMENT
DEVICE: NEWTRON BOOSTER SATELEC-ACTEON GROUP 510(k) NO: K131997(TRADITIONAL) ATTN: RICK ROSATI PHONE NO : 800 289 6367 124 GAITHER DRIVE , SUITE 140 SE DECISION MADE: 26-NOV-13 MT LAUREL NJ 08054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEM SPINEFRONTIER, INC. 510(k) NO: K132740(TRADITIONAL) ATTN: PAUL L SPEIDEL PHONE NO : 978 232 3990 500 CUMMINGS CENTER SUITE 3500 SE DECISION MADE: 26-NOV-13 BEVERLY MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIATHLON TRITANIUM METAL-BACKED PATELLA STRYKER ORTHOPAEDICS 510(k) NO: K132624(TRADITIONAL) ATTN: SHIKHA KHANDELWAL PHONE NO : 201 831 6921 325 CORPORATE DRIVE SE DECISION MADE: 26-NOV-13 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN ROCHE DIAGNOSTICS 510(k) NO: K133330(SPECIAL) ATTN: SUSAN HOLLANDBECK PHONE NO : 317 521 3380 9115 SOUTH HAGUE ROAD SE DECISION MADE: 26-NOV-13 INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KNIT-PAK+ PREMIER DENTAL PRODUCTS CO. 510(k) NO: K132526(TRADITIONAL) ATTN: VINCENT D’ALLESANDRO PHONE NO : 610 239 6000 1710 ROMANO DR. SE DECISION MADE: 26-NOV-13 PLYMOUTH MEETING PA 19462 510(k) STATEMENT
DEVICE: FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K131369(TRADITIONAL) ATTN: LEIGH SPOTTEN PHONE NO : 424 218 8738 2151 E. GRAND AVENUE SE DECISION MADE: 26-NOV-13 EL SEGUNDO CA 90245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYBERWAND STERILE PROBE SET CYBERSONICS, INC. 510(k) NO: K132795(SPECIAL) ATTN: LORI COLVIN PHONE NO : 814 898 4734 5325 KUHL RD. SE DECISION MADE: 26-NOV-13 Erie PA 16510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASPIRE RX-LP6 ASPIRATION CATHETER CONTROL MEDICAL TECHNOLOGY, LLC 510(k) NO: K131998(TRADITIONAL) ATTN: SHAWN FOJTIK PHONE NO : 435 602 9640 136 HEBER AVENUE, SUITE 101 PO BOXSE DECISION MADE: 26-NOV-13 PARK CITY UT 84068 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW
DEVICE: GENESIS LED WANDS GENESIS BIOSYSTEMS, INC. 510(k) NO: K131142(TRADITIONAL) ATTN: JIM LAFFERTY PHONE NO : 972 315 7888 1500 EAGLE COURT SE DECISION MADE: 27-NOV-13 LEWISVILLE TX 75057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JUSHA-M52C MEDICAL DISPLAY NANJING JUSHA DISPLAY TECHNOLOGY C510(k) NO: K131390(TRADITIONAL) ATTN: MIKE GU PHONE NO : 86 20 62321333 7TH FLOOR, 982. CONGYUN RD. BAIYUNSE DECISION MADE: 27-NOV-13 GUANGZHOU, GUANGDONG CH 510420 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARCHON ANTERIOR CERVICAL PLATE SYSTEM NUVASIVE, INC. 510(k) NO: K131025(TRADITIONAL) ATTN: CYNTHIA ADAMS PHONE NO : 858 320 4549 7475 LUSK BLVD SE DECISION MADE: 27-NOV-13 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROGS MOLECULAR PRODUCTS LTD. 510(k) NO: K131016(SPECIAL) ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSAGE DR. SE DECISION MADE: 27-NOV-13 BONITA SPRINGS FL 34134 2958 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE ADVANCED BRAIN MONITORING INC. 510(k) NO: K131383(TRADITIONAL) ATTN: ADRIENNE LENZ PHONE NO : 262 290 0023 W324 S3649 COUNTY ROAD E SE DECISION MADE: 27-NOV-13 DOUSMAN WI 53118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE) PEGA MEDICAL INC. 510(k) NO: K131591(TRADITIONAL) ATTN: ARIEL R DUJOVNE PHONE NO : 450 688514 4 1111 AUTOROUTE CHOMEDEY SE DECISION MADE: 27-NOV-13 LAVAL CA H7W 5J8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TITLE 2 POLYAXIAL SPINAL SYSTEM ZIMMER SPINE, INC. 510(k) NO: K133086(TRADITIONAL) ATTN: MICHELLE LENZ PHONE NO : 952 830 6243 7375 BUSH LAKE RD. SE DECISION MADE: 27-NOV-13 MINNEAPOLIS MN 55439 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESPIN SYSTEM NLT SPINE LTD 510(k) NO: K133061(TRADITIONAL) ATTN: JOHN J SMITH PHONE NO : 202 637 3638 555 13TH ST NW SE DECISION MADE: 27-NOV-13 WASHINGTON DC 20004 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM REVERSE MEDICAL CORPORATION 510(k) NO: K133282(SPECIAL) ATTN: JEFFREY VALKO PHONE NO : 949 215 0660 13700 Alton Parkway Suite 167 SE DECISION MADE: 27-NOV-13 Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MYLABSEVEN, MYLABALPHA ESAOTE, S.P.A. 510(k) NO: K132231(TRADITIONAL) ATTN: ALLISON SCOTT PHONE NO : 317 569 9500 9001 WESLEYAN ROAD SUITE 200 SE DECISION MADE: 27-NOV-13 INDIANAPOLIS IN 46268 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNMAX SYNTHETIC EXAMINATION VINYL GLOVES, POWDER FREE, BLUE COLOR ZIBO INTCO MEDICAL PRODUCTS CO., L510(k) NO: K132201(TRADITIONAL) ATTN: JOHN ZHAO PHONE NO : 909 548 4828 12390 EAST END AVE. SE DECISION MADE: 27-NOV-13 CHINO CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-CUBE 7 ALPINION MEDICAL SYSTEMS CO., LTD 510(k) NO: K132687(TRADITIONAL) ATTN: DONGHWAN KIM PHONE NO : 82 70 74652068 1, 6 AND 7FL, VERDI TOWER 72, DIGISE DECISION MADE: 27-NOV-13 SEOUL KS 152-848 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIP MIS INTERSPINOUS FUSION SYSTEM AURORA SPINE 510(k) NO: K133091(TRADITIONAL) ATTN: JUSTIN EGGLETON PHONE NO : 202 552 5800 331 H STREET NW, 12TH FL. SE DECISION MADE: 27-NOV-13 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UGEO WS80A DIAGNOSTIC ULTRASOUND SYSTEM SAMSUNG MEDISON CO., LTD 510(k) NO: K133329(TRADITIONAL) ATTN: PARK KYEONG-MI PHONE NO : 42, TEHERAN-RO 108-GIL GANGNAM-GU SE DECISION MADE: 27-NOV-13 SEOUL KS 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW
DEVICE: HEMOCLIP TRADITIONAL LIGATING CLIPS, HEMOCLIP PLUS LIGATING CLIPS, HORIZON LIGTING CLIPS TELEFLEX MEDICAL 510(k) NO: K132658(TRADITIONAL) ATTN: ASHLEA RICCI, RAC PHONE NO : 919 433 8065 2917 WECK DR. SE DECISION MADE: 27-NOV-13 RESEARCH TRIANGLE PARK NC 27709 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPECULAR MICROSCOPE CEM-530 NIDEK CO., LTD. 510(k) NO: K130565(TRADITIONAL) ATTN: ARON SHAPIRO PHONE NO : 978 685 8900 300 BRICKSTONE SQUARE SE DECISION MADE: 27-NOV-13 ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PIEZOSURGERY FLEX MECTRON S.P.A. 510(k) NO: K132848(TRADITIONAL) ATTN: ROGER GRAY PHONE NO : 39 06 5782665 PIAZZA ALBANIA 10 SE DECISION MADE: 29-NOV-13 ROME IT 00153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INOMAX DSIR (DELIVERY SYSTEM) INO THERAPEUTICS/IKARIA 510(k) NO: K131686(TRADITIONAL) ATTN: ROBERT BOVY PHONE NO : 608 226 3450 2902 DAIRY DRIVE SE DECISION MADE: 29-NOV-13 MADISON WI 53718 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LESSRAY SAFERAY SPINE, LLC 510(k) NO: K132970(SPECIAL) ATTN: CALLEY HERZOG PHONE NO : 720 883 3633 400 N. WASHINGTON ST., STE 100 SE DECISION MADE: 29-NOV-13 ALEXANDRIA VA 22314 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANQUILL BARBED DEVICE SURGICAL SPECIALTIES CORP. DBA ANG510(k) NO: K133420(SPECIAL) ATTN: KIRSTEN STOWELL PHONE NO : 610 404 3367 100 DENNIS DR. SE DECISION MADE: 29-NOV-13 Reading PA 19606 510(k) SUMMARY AVAILABLE FROM FDA
Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance
You must be logged in to post a comment.
Copyright © 2022 · WTWH Media LLC and its licensors. All rights reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.