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Medical Devices

November 2013 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD November 2013


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


                                                 TOTAL 510(k)s THIS PERIOD   224                                     
                                                 TOTAL WITH SUMMARIES        212                                     
                                                 TOTAL WITH STATEMENTS        12
                                      

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