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Medical Devices

April 2014 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD April 2014
 
 
DEVICE: OMNYX IDP FOR HER2 MANUAL APPLICATION
OMNYX, LLC                        510(k) NO: K131140(TRADITIONAL)
ATTN: GAIL E RADCLIFFE            PHONE NO : 508 835 1688   
62 FOREST STREET, SUITE 300       SE DECISION MADE: 01-APR-14
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: A1C GEAR SYSTEM
SAKAE CORPORATION                 510(k) NO: K130014(TRADITIONAL)
ATTN: ERICA B AMMIRATI            PHONE NO : 650 949 2768   
575 SHIRLYNN COURT                SE DECISION MADE: 04-APR-14
LOS ALTOS CA 94022                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ARTUS C. DIFFICILE QS-RGQ MDX KIT
QIAGEN, GMBH                      510(k) NO: K133936(TRADITIONAL)
ATTN: KIMBERLY  MAPP              PHONE NO : 301 944 7817   
1201 CLOPPER RD                   SE DECISION MADE: 04-APR-14
GAITHERSBURG MD 20878             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: WUNDER PREGNANCY TEST
JAMES NGUYEN                      510(k) NO: K130456(TRADITIONAL)
ATTN: JAMES  NGUYEN, M.D.         PHONE NO : 408 569 5454   
2231 FORTUNE DR, STE D            SE DECISION MADE: 08-APR-14
SAN JOSE CA 95131                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CR3 KEYLESS SPLIT SAMPLE CUP(OPI-BZO)
GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K140089(TRADITIONAL)
ATTN: JOE  SHIA                   PHONE NO : 240 505 7880   
504 EAST DIAMOND AVE. SUITE F     SE DECISION MADE: 08-APR-14
GAITHERSBURG MD 20878             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ELEMENT TM LITE BLOOD GLUCOSE MONITORING SYSTEM
LK CONSULTING GROUP USA, INC.     510(k) NO: K133045(TRADITIONAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 202 5789   
2651 E CHAPMAN AVE STE 110        SE DECISION MADE: 10-APR-14
FULLERTON CA 92831                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FREELITE HUMAN LAMBDA FREE KIT
THE BINDING SITE GROUP, LTD.      510(k) NO: K140396(TRADITIONAL)
ATTN: DOUG  KURTH                 PHONE NO : 
5889 OBDERLIN DR., STE 101        SE DECISION MADE: 16-APR-14
SAN DIEGO CA 92121                510(k) STATEMENT
 
DEVICE: HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS
THE BINDING SITE GROUP, LTD.      510(k) NO: K140664(TRADITIONAL)
ATTN: JON  LAUDER                 PHONE NO : 44 121 4569500
8 CALTHORPE ROAD                  SE DECISION MADE: 16-APR-14
EDGBASTON    UK B15 1QT           510(k) STATEMENT
 
DEVICE: ELEMENTV BLOOD GLUCOSE MONITORING SYSTEM
INFOPIA CO., LTD                  510(k) NO: K132406(TRADITIONAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 202 5789   
2651 E CHAPMAN AVE STE 110        SE DECISION MADE: 18-APR-14
FULLERTON CA 92833                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEM
EPS BIO TECHNOLOGY CORP.          510(k) NO: K133537(SPECIAL)
ATTN: CYNTHIA  HUNG               PHONE NO : 886 36 686868X652
NO.8 R&D RD III HSINCHU SCIENCE PASE DECISION MADE: 28-APR-14
HSINCHU CITY,    TW 30077         510(k) STATEMENT
 
DEVICE: VUPAD
SONOMED, INC.                     510(k) NO: K140199(TRADITIONAL)
ATTN: CHARLES C O'NEAL            PHONE NO : 516 354 0900   
1979 MARCUS AVE., SUITE 105C      SE DECISION MADE: 01-APR-14
LAKE SUCCESS NY 11042             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VADO STEERABLE SHEATH
KALILA MEDICAL, INC.              510(k) NO: K140420(TRADITIONAL)
ATTN: CARRIE  NEUBERGER           PHONE NO : 415 640 3377   
745 CAMDEN AVE, SUITE A           SE DECISION MADE: 01-APR-14
CAMPBELL CA 95008                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: IMMULITE 2000: C-PEPTIDE CALIBRATION VERIFICATION MATERIAL, SHBG CALIBRATION VERIFICATION MATERIAL, TOTAL TESTOSTERONE C
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K140541(ABBREVIATED)
ATTN: GARO  MIMARYAN              PHONE NO : 914 524 3270   
511 BENEDICT AVE.                 SE DECISION MADE: 01-APR-14
TARRYTOWN NY 10591                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MODIFIED DISTAL RADIUS PLATING SYSTEM
BIOMET                            510(k) NO: K133939(TRADITIONAL)
ATTN: SUZANA  OTANO               PHONE NO : 305 269 6386   
56 EAST BELL DRIVE PO BOX 587     SE DECISION MADE: 01-APR-14
WARSAW IN 46581                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VARIAX CLAVICLE HOOK PLATE
STRYKER TRAUMA AG                 510(k) NO: K140259(TRADITIONAL)
ATTN: ELIJAH N WREH               PHONE NO : 201 831 5691   
325 CORPORATE DRIVE               SE DECISION MADE: 01-APR-14
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TABLET VIEWER SOFTWARE FOR IMAGE SUITE
CARESTREAM HEALTH, INC.           510(k) NO: K140271(TRADITIONAL)
ATTN: ALEXANDRA  CHAMBERLAIN      PHONE NO : 585 627 8790   
150 VERONA STREET                 SE DECISION MADE: 01-APR-14
ROCHESTER NY 14608                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: IMBIBE NEEDLE
ORTHOVITA, INC.                   510(k) NO: K140414(TRADITIONAL)
ATTN: JOHN  URTZ                  PHONE NO : 610 407 7450   
77 GREAT VALLEY PARKWAY           SE DECISION MADE: 01-APR-14
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: N8TIVE ACL ANATOMIC RECONSTRUCTION SYSTEM, N8TIVE ACL FEMORAL IMPLANT, N8TIVE ACL TIBIAL IMPLANT, VARIOUS CLASS I ANCILL
ARTHROCARE CORPORATION            510(k) NO: K133606(TRADITIONAL)
ATTN: MITCHELL  DHORITY           PHONE NO : 512 358 5995   
7000 West William Cannon Drive    SE DECISION MADE: 01-APR-14
Austin TX 78735                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: INNESIS PEEK CERVICAL CAGE
BK MEDITECH CO., LTD.             510(k) NO: K132483(TRADITIONAL)
ATTN: ELAINE  DUNCAN              PHONE NO : 715 549 6035   
PO BOX 560                        SE DECISION MADE: 02-APR-14
STILLWATER MN 55082               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AHP 300, EMERGENCY PORTABLE VENTILATOR
ALLIED HEALTHCARE PRODUCTS, INC.  510(k) NO: K132021(TRADITIONAL)
ATTN: STEPHEN  MUNDWILLER         PHONE NO : 314 268 1661   
1720 SUBLETTE AVE.                SE DECISION MADE: 02-APR-14
Saint Louis MO 63110              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SIGNATURE PLANNER, SIGNATURE GUIDES
MATERIALISE N.V.                  510(k) NO: K140257(TRADITIONAL)
ATTN: OLIVER  CLEMENS             PHONE NO : 321 674453 7
15 TECHNOLOGIELAAN                SE DECISION MADE: 02-APR-14
LEUVEN    BE 3001                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER
BOSTON SCIENTIFIC CORPORATION     510(k) NO: K133933(SPECIAL)
ATTN: ASHLEY  SANTOS              PHONE NO : 508 683 4359   
100 BOSTON SCIENTIFIC WAY         SE DECISION MADE: 02-APR-14
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MEDICALYTE(R) BICARBONATE POWDER (36.83X), MEDICALYTE(R) BICARBONATE POWDER (45X), MEDICALYTE(R) BICARBONATE POWDER (35X
DIALYSIS MEDICAL SOLUTIONS, LLC   510(k) NO: K131202(TRADITIONAL)
ATTN: COURTNEY J MILLER           PHONE NO : 614 719 2858   
21 EAST STATE STREET SUITE 1700   SE DECISION MADE: 03-APR-14
COLUMBUS OH 43215                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: KOBOLD SECURE LOCK TRANSFER GUIDE TUBE SET; KOBOLD LUER TRANSFER GUIDE TUBE SET
SPENCER FILLMORE                  510(k) NO: K130757(TRADITIONAL)
ATTN: CHRISTINA  BERNSTEIN        PHONE NO : 415 450 0515   
2670 LEAVENWORTH ST.              SE DECISION MADE: 03-APR-14
SAN FRANCISCO CA 94133            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VIZION ULTRA
VIZTEK LLC                        510(k) NO: K133139(SPECIAL)
ATTN: DANIEL  KAMM, P.E.          PHONE NO : 239 234 1735   
8870 RAVELLO CT                   SE DECISION MADE: 03-APR-14
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FLEXIBLE COOAGEN NERVE CUFF
COLLAGEN MATRIX, INC.             510(k) NO: K131541(TRADITIONAL)
ATTN: PEGGY  HANSEN               PHONE NO : 201 405 1477   
15 THORNTON ROAD                  SE DECISION MADE: 03-APR-14
OAKLAND NJ 07436                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ACUITY PRO LEAD DELIVERY SYSTEM
BOSTON SCIENTIFIC                 510(k) NO: K132914(TRADITIONAL)
ATTN: HOLLY  RAMIREZ              PHONE NO : 763 494 2113   
ONE SCIMED PLACE                  SE DECISION MADE: 03-APR-14
MAPLE GROVE MN 55311 1566         510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ZOLL CODE WRITER
ZOLL MEDICAL CORPORATION          510(k) NO: K132488(TRADITIONAL)
ATTN: SHANNON  DUHAMEL            PHONE NO : 978 421 9574   
269 MILL ROAD                     SE DECISION MADE: 03-APR-14
CHELMSFORD MA 01824               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PERCLOT TOPICAL
CRYOLIFE, INC.                    510(k) NO: K132105(TRADITIONAL)
ATTN: KIMBERLY  DICONO            PHONE NO : 770 419 3355   
1655 ROBERTS BLVD., N.W.          SE DECISION MADE: 03-APR-14
KENNESAW GA 30144                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MEDSOURCE IV ADMINISTRATION SET 72" MEDSOURCE IV ADMINISTRATION SET, NEEDLELESS MALE ADAPTER, MEDSOURCE IV EXTENSION SET
MEDSOURCE INTERNATIONAL, LLC.     510(k) NO: K140402(SPECIAL)
ATTN: JENNIFER  NESS              PHONE NO : 952 241 8318   
5346 SHORELINE DR.                SE DECISION MADE: 03-APR-14
MOUND MN 55364                    510(k) STATEMENT
 
DEVICE: COROENT SMALL INTERBODY SYSTEM
NUVASIVE, INC.                    510(k) NO: K140003(TRADITIONAL)
ATTN: CYNTHIA  ADAMS              PHONE NO : 858 320 4549   
7475 LUSK BLVD                    SE DECISION MADE: 03-APR-14
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ALEUTIAN IBF SYSTEM
K2M, INC.                         510(k) NO: K133614(TRADITIONAL)
ATTN: NANCY  GIEZEN               PHONE NO : 703 777 3155   
751 MILLER DR SE                  SE DECISION MADE: 03-APR-14
LEESBURG VA 22066                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLOX DELTA FEMORAL HEAD
MICROPORT ORTHOPEDICS INC.        510(k) NO: K140043(TRADITIONAL)
ATTN: MAX  MORTENSEN              PHONE NO : 901 485 1102   
5677 AIRLINE RD                   SE DECISION MADE: 03-APR-14
Arlington TN 38002                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VERISUITE 1.8, VERISUITE-PARTICLE 1.8, VERISUITE, VERISUITE-PARTICLE
MEDCOM GMBH                       510(k) NO: K133914(ABBREVIATED)
ATTN: LUCA  SALVATORE             PHONE NO : 49 6151 9514718
RUNDETURMSTRASSE 12               SE DECISION MADE: 03-APR-14
DARMSTADT    GM 64283             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DEPUY GLOBAL UNITE SHOULDER SYSTEM
DEPUY (IRELAND)                   510(k) NO: K133834(TRADITIONAL)
ATTN: KELLIE  MYERS               PHONE NO : 574 372 7276
LOUGHBEG RINGASKIDDY              SE DECISION MADE: 03-APR-14
CO. CORK    EI IRELAND            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SUB-Q SUBCUTANEOUS TISSUE INFUSION SET
EMED TECHNOLOGIES CORPORATION     510(k) NO: K140131(SPECIAL)
ATTN: PETER  KOLLINGS             PHONE NO : 916 932 0071   
1264 Hawks Flight Ct Ste 200      SE DECISION MADE: 03-APR-14
EL DORADO HILLS CA 95762          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VITALCONNECT PLATFORM BY VITAL CONNECT INC.
VITAL CONNECTIONS, INC.           510(k) NO: K132447(TRADITIONAL)
ATTN: SAM  MOSTAFAVI              PHONE NO : 408 963 4620   
900 E. HAMILTON AVE. STE # 500    SE DECISION MADE: 03-APR-14
CAMPBELL CA 95008                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CRYOTOP(R) SC
KITAZATO BIOPHARMA CO., LTD.      510(k) NO: K140072(TRADITIONAL)
ATTN: RICHARD  VINCINS            PHONE NO : 512 327 9997   
816 CONGRESS AVE SUITE 1400       SE DECISION MADE: 03-APR-14
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MACH LED 2SC
DR. MACH GMBH & CO. KG            510(k) NO: K140460(SPECIAL)
ATTN: GUDRUN  BUSCH, PH.D.        PHONE NO : 49 40 58979794
FEHMARNSTRASSE 31                 SE DECISION MADE: 03-APR-14
NORDERSTEDT, SCHLESWIG-HOLSTEIN   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MACH LED 2MC
DR. MACH GMBH & CO. KG            510(k) NO: K140461(SPECIAL)
ATTN: GUDRUN  BUSCH, PH.D.        PHONE NO : 49 40 58979794
FEHMARNSTRASSE 31                 SE DECISION MADE: 03-APR-14
NORDERSTEDT, SCHLESWIG-HOLSTEIN   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VARIAX 2 SYSTEM
STRYKER TRAUMA AG                 510(k) NO: K140376(TRADITIONAL)
ATTN: ESTELA  CELI                PHONE NO : 201 831 6461   
325 CORPORATE DRIVE               SE DECISION MADE: 03-APR-14
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CLOUDEKG
MAKROMED, INC.                    510(k) NO: K130878(TRADITIONAL)
ATTN: BARRY V ASHAR               PHONE NO : 603 890 3311   
88 STILES ROAD                    SE DECISION MADE: 04-APR-14
SALEM NH 03079                    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: I.B.S SNAP-OFF SCREW / SOLAFIX SNAP-OFF SCREW
IN2BONES SAS                      510(k) NO: K132911(TRADITIONAL)
ATTN: ERIC  FOURCAULT             PHONE NO : 
28 CHEMIN DU PETIT BOIS 69130 ECULSE DECISION MADE: 04-APR-14
FRANCE    FR 69130                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CLEARMRI HELIOS-RG8 COIL ACCESSORY KIT
CLEARMRI SOLUTIONS, INC.          510(k) NO: K132381(TRADITIONAL)
ATTN: MARY ANN  FERGUSON          PHONE NO : 978 578 1196   
W315 S3283 Harvest View Drive     SE DECISION MADE: 04-APR-14
Waukesha WI 53189                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: 8MP COLOR LCD MONITOR, RADIFORCE RX850
EIZO CORPORATION                  510(k) NO: K140702(TRADITIONAL)
ATTN: HIROAKI  HASHIMOTO          PHONE NO : 81 76 2742468
153 SHIMOKASHIWANO                SE DECISION MADE: 04-APR-14
HAKUSAN    JP 924-8566            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT REPLACE
NOBEL BIOCARE AB                  510(k) NO: K133377(TRADITIONAL)
ATTN: PHUONG  NGUYEN              PHONE NO : 714 282 4800   
22715 SAVI RANCH PKWY.            SE DECISION MADE: 04-APR-14
YORBA LINDA CA 92887              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NORDICBRAINEX
NORDICNEUROLAB                    510(k) NO: K133910(TRADITIONAL)
ATTN: CHANDANA GURUNG  BHANDARI   PHONE NO : 475 57 07095
MOLLENDALSVEIEN 65C               SE DECISION MADE: 04-APR-14
BERGEN    NO N-5009               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: US ENDOSCOPY DISTAL ATTACHMENT CAP
UNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K140315(TRADITIONAL)
ATTN: SAGAR D PIMPALWAR           PHONE NO : 440 639 4494   
5976 HEISLEY RD.                  SE DECISION MADE: 04-APR-14
MENTOR OH 44060                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AFTAMED MOUTHWASH; AFTAMED GEL; AFTAMED SPRAY; AFTAMED SHIELD; AFTAMED JUNIOR GEL
BIOPLAX LIMITED                   510(k) NO: K130959(TRADITIONAL)
ATTN: PAUL  KETTERIDGE            PHONE NO : 443 729 0836   
472 S STATE STREET, #101          SE DECISION MADE: 04-APR-14
BELLINGHAM WA 98225               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TSP HIP FRACTURE PLATING SYSTEM
BIOMET, INC.                      510(k) NO: K140018(TRADITIONAL)
ATTN: GARY  BAKER                 PHONE NO : 574 267 6639   
56 EAST BELL DR.                  SE DECISION MADE: 04-APR-14
WARSAW IN 46581 0587              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TORNIER INSITE(TM) FT PEEK KNOTLESS SUTURE ANCHOR
TORNIER, INC.                     510(k) NO: K133777(TRADITIONAL)
ATTN: MIREILLE  LEMERY            PHONE NO : 
10801 NESBITT AVENUE SOUTH        SE DECISION MADE: 04-APR-14
BLOOMINGTON MN 55437              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TRIBALL INCENTIVE SPIROMETER
BESMED HEALTH BUSINESS CORP.      510(k) NO: K133873(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155
NO.5, LANE116, WU-KONG 2ND RD     SE DECISION MADE: 04-APR-14
NEW TAIPEI CITY, WU-KU DISTRICT   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ARIA RADIATION THERAPY MANAGEMENT
VARIAN MEDICAL SYSTEMS, INC.      510(k) NO: K133572(TRADITIONAL)
ATTN: PETER J CORONADO            PHONE NO : 650 424 5731   
3120 HANSEN WAY C-260             SE DECISION MADE: 04-APR-14
PALO ALTO CA 94304                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BARD RITECATH INTERMITTENT CATHETER
C.R. BARD, INC.                   510(k) NO: K133470(TRADITIONAL)
ATTN: MICHELE  DAVIS              PHONE NO : 770 784 6274   
8195 INDUSTRIAL BLVD              SE DECISION MADE: 04-APR-14
COVINGTON GA 30014                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SYNGO DUAL ENERGY SOFTWARE PACKAGE
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K132902(TRADITIONAL)
ATTN: KIMBERLY  MANGUM            PHONE NO : 610 448 4912   
51 VALLEY STREAM PKWY.            SE DECISION MADE: 07-APR-14
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: HYDROPHILIC COATED GUIDEWIRE
LAKE REGION MEDICAL               510(k) NO: K133155(TRADITIONAL)
ATTN: TRACY  MEYER                PHONE NO : 952 448 5111   
340 LAKE HAZELTINE DRIVE          SE DECISION MADE: 07-APR-14
CHASKA MN 55318                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: THREADED PEEK K-WIRE
MTP SOLUTIONS LLC                 510(k) NO: K133235(TRADITIONAL)
ATTN: ROBERT  HOY                 PHONE NO : 614 448 6358   
124 SOUTH 600 WEST, SUITE 100     SE DECISION MADE: 07-APR-14
LOGAN UT 84321                    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MEDINAUT KYPHOPLASTY SYSTEM
IMEDICOM                          510(k) NO: K133669(TRADITIONAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 922 5276   
2651 E CHAPMAN AVE STE 110        SE DECISION MADE: 07-APR-14
FULLERTON CA 92833                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SPEED TRIAD
BIOMEDICAL ENT., INC.             510(k) NO: K133844(SPECIAL)
ATTN: JOE  SOWARD                 PHONE NO : 210 677 0354   
14785 OMICRON DR., SUITE 205      SE DECISION MADE: 07-APR-14
SAN ANTONIO TX 78245              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS 3.0
MERETE MEDICAL GMBH               510(k) NO: K140069(TRADITIONAL)
ATTN: EMMANUEL  ANAPLIOTIS        PHONE NO : 493 077998 0114
102 ALT LANKWITZ                  SE DECISION MADE: 07-APR-14
BERLIN    GM D-12247              510(k) STATEMENT
 
DEVICE: FRAGMENT PLATE SYSTEM
SKELETAL DYNAMICS, LLC            510(k) NO: K140372(TRADITIONAL)
ATTN: ANA M ESCAGEDO              PHONE NO : 305 596 7585   
8905 SW 87 AVENUE, SUITE 201      SE DECISION MADE: 07-APR-14
MIAMI FL 33176                    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ABACUS TM SPACER SYSTEM
SPINE WAVE, INC.                  510(k) NO: K140007(TRADITIONAL)
ATTN: JOSEPH  MERCADO             PHONE NO : 203 944 9494   
THREE ENTERPRISE DR. SUITE 210    SE DECISION MADE: 07-APR-14
SHELTON CT 06484                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BAXANO SURGICAL MIS SPINAL SYSTEM
BAXANO SURGICAL, INC.             510(k) NO: K133743(TRADITIONAL)
ATTN: KRISTEN  ALLEN              PHONE NO : 910 332 1733   
301 Government Center Drive       SE DECISION MADE: 07-APR-14
Wilmington NC 28403               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ULTRAFUSE
BAXTER HEALTHCARE CORP.           510(k) NO: K130531(TRADITIONAL)
ATTN: GRETCHEN  MURRAY            PHONE NO : 805 372 3065   
ONE BAXTER WAY                    SE DECISION MADE: 08-APR-14
WESTLAKE VILLAGE CA 91362         510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FLIGHT 60 VENTILATOR
FLIGHT MEDICAL INNOVATIONS LTD.   510(k) NO: K130171(TRADITIONAL)
ATTN: SHOSHANA  FRIEDMAN          PHONE NO : 704 899 0092   
1914 JN PEASE PLACE               SE DECISION MADE: 08-APR-14
CHARLOTTE NC 28262                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: THE GYNOCULAR
GYNIUS AB                         510(k) NO: K132423(TRADITIONAL)
ATTN: MATTHEW  VOLSKY             PHONE NO : 46 700 237670
DOBELNSGATAN 23                   SE DECISION MADE: 08-APR-14
STOCKHOLM    SW 11140             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MANDREL GUIDEWIRE
LAKE REGION MEDICAL               510(k) NO: K140482(SPECIAL)
ATTN: MATHEW  PEXA                PHONE NO : 952 488 5111   
340 LAKE HAZELTINE DRIVE          SE DECISION MADE: 08-APR-14
CHASKA MN 55318                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: POWDER FREE NITRILE PATIENT EXAMINATION GLOVE,BLUE AND ORANGE COLORED,NON-STERILE TESTED FOR USE WITH CHEMOTHERAPY DRUGS
TOP CALIBRE SDN BHD               510(k) NO: K133949(TRADITIONAL)
ATTN: ROSNITA  MAODIN             PHONE NO : 603 329105 16
Lot 13726, Jalan Haji Salleh, BatuSE DECISION MADE: 08-APR-14
KLANG, SELANGOR    MY 41050       510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SURGICAL LIGHT HANDLE COVER
MICROTEK MEDICAL, INC. AN ECOLAB C510(k) NO: K133554(SPECIAL)
ATTN: ANDY  ROLLER                PHONE NO : 651 293 2080   
370 WABASHA STREET N              SE DECISION MADE: 08-APR-14
ST. PAUL MN 55102                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ORTHROS POSTERIOR STABILIZATION SYSTEM
CAMBER SPINE                      510(k) NO: K133366(TRADITIONAL)
ATTN: DANIEL A PONTECORVO         PHONE NO : 484 420 4671   
90 S. NEWTOWN STREET RD. SUITE 10 SE DECISION MADE: 08-APR-14
NEWTOWN SQUARE PA 19073           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: KANGAROO FEEDING TUBES WITH IRIS TECHNOLOGY
COVIDIEN                          510(k) NO: K123555(TRADITIONAL)
ATTN: JIM  WELSH                  PHONE NO : 508 261 8532   
15 HAMPSHIRE STREET               SE DECISION MADE: 09-APR-14
MANSFIELD MA 02048                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MEGA ISQ
OSSTELL AB                        510(k) NO: K132401(SPECIAL)
ATTN: CHERITA  JAMES              PHONE NO : 703 562 9800   
901 KING STREET SUITE 101         SE DECISION MADE: 09-APR-14
ALEXANDRIA VA 22314               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ZELTIQ COOLSCULPTING SYSTEM
ZELTIQ AESTHETICS, INC.           510(k) NO: K133212(TRADITIONAL)
ATTN: SHRUTI  JAYAKUMAR           PHONE NO : 925 621 2516   
4698 Willow Road                  SE DECISION MADE: 09-APR-14
Pleasanton CA 94588               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEM
OPUS KSD, INC.                    510(k) NO: K131563(TRADITIONAL)
ATTN: ROSINA  ROBINSON, RN, MED, RPHONE NO : 508 247 7244   
62 FOREST STREET SUITE 300        SE DECISION MADE: 09-APR-14
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: STRYKER TEMPORARY CONDYLAR PROSTHESIS
STRYKER                           510(k) NO: K133285(TRADITIONAL)
ATTN: JAMSHED  BADARPURA          PHONE NO : 269 389 4260   
750 TRADE CENTRE WAY STE 200      SE DECISION MADE: 09-APR-14
PORTAGE MI 49002                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: HTFX-222
GC AMERICA, INC.                  510(k) NO: K133182(TRADITIONAL)
ATTN: MARK  HEISS                 PHONE NO : 708 597 0900   
3737 WEST 127TH ST.               SE DECISION MADE: 09-APR-14
ALSIP IL 60803                    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PENTAX VIDEO COLONOSCOPES (EC FAMILY)
PENTAX MEDICAL COMPANY            510(k) NO: K131855(TRADITIONAL)
ATTN: KRISHNA  GOVINDARAJAN       PHONE NO : 800 431 5880   
3 Paragon Drive                   SE DECISION MADE: 09-APR-14
MONTVALE NJ 07645                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EMERGENCY PORTABLE VENTILATOR
ALLIED HEALTHCARE PRODUCTS, INC.  510(k) NO: K131098(TRADITIONAL)
ATTN: STEPHEN  MUNDWILLER         PHONE NO : 314 268 1661   
1720 SUBLETTE AVE.                SE DECISION MADE: 09-APR-14
ST LOUIS MO 63110                 510(k) STATEMENT
 
DEVICE: MD-FLEX HEAVY BODY
META BIOMED, INC.                 510(k) NO: K134008(TRADITIONAL)
ATTN: BLIX  WINSTON               PHONE NO : 301 607 9185   
2600 MULLINIX MILL ROAD           SE DECISION MADE: 09-APR-14
MT. AIRY MD 21771                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CMOS VIDEO NASOPHARYNGOSCOPE SYSTEM
SCHOELLY FIBEROPTIC, GMBH         510(k) NO: K132009(TRADITIONAL)
ATTN: PAMELA  PAPINEAU, RAC       PHONE NO : 978 772 3552   
5 WHITCOMB AVE.                   SE DECISION MADE: 09-APR-14
AYER MA 01432                     510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: LEXICONTURE MECHANICAL DILATOR SHEATH SET
SPECTRANETICS CORP.               510(k) NO: K140047(TRADITIONAL)
ATTN: PHAROAH  GARMA              PHONE NO : 719 447 2385   
9665 FEDERAL DRIVE                SE DECISION MADE: 09-APR-14
COLORADO SPRINGS CO 80921         510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TRC-PASTE
KM CORPORATION                    510(k) NO: K133716(TRADITIONAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 202 5789   
1515 E. KATELLA AVE UNIT 2115     SE DECISION MADE: 09-APR-14
ANAHEIM CA 92805                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VIORA V-TOTAL
VIORA LTD.                        510(k) NO: K133837(TRADITIONAL)
ATTN: YORAM  LEVY                 PHONE NO : 972 4 6388837
31 HAAVODA ST.                    SE DECISION MADE: 09-APR-14
BINYAMINA    IS 30500             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RELIATACK ARTICULATING RELOADABLE FIXATION DEVICE WITH STANDARD PURCHASE ABSORBLE TACKS
COVIDIEN                          510(k) NO: K140609(SPECIAL)
ATTN: CLARE  SANTULLI             PHONE NO : 203 492 7635   
60 MIDDLETOWN AVE                 SE DECISION MADE: 09-APR-14
NORTH HAVEN CT 06473              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MULTIX SELECT DR
SIEMENS MEDICAL SOLUTIONS, INC.   510(k) NO: K132934(TRADITIONAL)
ATTN: PATRICIA D JONES            PHONE NO : 610 448 3536   
51 VALLEY STREAM PARKWAY          SE DECISION MADE: 10-APR-14
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: IEEG
JORDAN NEUROSCIENCE, INC.         510(k) NO: K131944(TRADITIONAL)
ATTN: ANNE  PERRY                 PHONE NO : 909 881 2694   
1660 PLUM LANE                    SE DECISION MADE: 10-APR-14
REDLANDS CA 92374                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY)
PENTAX MEDICAL COMPANY            510(k) NO: K131902(TRADITIONAL)
ATTN: KRISHNA  GOVINDARAJAN       PHONE NO : 800 431 5880   
3 Paragon Drive                   SE DECISION MADE: 10-APR-14
MONTVALE NJ 07645                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CONTOUR I V3.1 SYSTEM
SYNERON MEDICAL LTD               510(k) NO: K133238(TRADITIONAL)
ATTN: JANICE M HOGAN              PHONE NO : 267 675 4611   
1835 MARKET ST, 29TH FLOOR        SE DECISION MADE: 10-APR-14
PHILADELPHIA PA 19103   19103     510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDES
MATERIALISE N.V.                  510(k) NO: K132290(TRADITIONAL)
ATTN: OLIVER  CLEMENS             PHONE NO : 32 16 744537
TECHNOLOGIELAAN 15                SE DECISION MADE: 10-APR-14
LEUVEN    BE 3001                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VECTRA NEO CLINICAL THERAPY SYSTEM
DJO, LLC                          510(k) NO: K132284(TRADITIONAL)
ATTN: MARIA  PRONINA              PHONE NO : 760 734 5599   
1430 Decision St                  SE DECISION MADE: 10-APR-14
VISTA CA 92081                    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: STREAMLINE TL SPINAL FIXATION SYSTEM
PIONEER SURGICAL TECHNOLOGY, INC  510(k) NO: K140696(SPECIAL)
ATTN: SARAH  MCINTYRE             PHONE NO : 906 225 5861   
375 RIVER PARK CIRCLE             SE DECISION MADE: 10-APR-14
Marquette MI 49855                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DUALGUARD
FLEXICARE MEDICAL LTD.            510(k) NO: K140473(TRADITIONAL)
ATTN: CHRISTOPHER  WATKINS        PHONE NO : 441 44 3471593
CYNON VALLEY BUSINESS PARK MOUTAINSE DECISION MADE: 10-APR-14
MID GLAMORGAN    UK CF45 4ER      510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: BIO-PROBE TRANSDUCER (ADULT)
MEDTRONIC INC.                    510(k) NO: K133903(TRADITIONAL)
ATTN: RAHUL  SHAH                 PHONE NO : 763 514 9846   
8200 CORAL SEA STREET NE          SE DECISION MADE: 10-APR-14
MOUNDS VIEW MN 55112              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PENTAX VIDEO BRONCHOSCOPES (EB FAMILY)
PENTAX MEDICAL COMPANY            510(k) NO: K131028(TRADITIONAL)
ATTN: KRISHNA  GOVINDARAJAN       PHONE NO : 800 431 5880   
3 Paragon Drive                   SE DECISION MADE: 10-APR-14
MONTVALE NJ 07645                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RETROMTA-ORTHOMTA II
BIOMTA                            510(k) NO: K132825(TRADITIONAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 202 5789   
2651 E CHAPMAN AVE STE 110        SE DECISION MADE: 10-APR-14
FULLERTON CA 92833                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: REPROCESSED LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER
STRYKER SUSTAINABILITY SOLUTIONS  510(k) NO: K133578(TRADITIONAL)
ATTN: JILL  CLARK                 PHONE NO : 480 763 5300   
1810 WEST DRAKE DRIVE             SE DECISION MADE: 10-APR-14
TEMPE AZ 85283                    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM
COVIDIEN                          510(k) NO: K140339(TRADITIONAL)
ATTN: BRIANNA  REYNOLDS           PHONE NO : 303 305 2728   
6135 GUNBARREL AVE.               SE DECISION MADE: 10-APR-14
BOULDER CO 80301                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ST AIA-PACK C-PEPTIDE II CALIBRATOR SET
TOSOH BIOSCIENCE, INC.            510(k) NO: K140648(ABBREVIATED)
ATTN: ROBERT L WICK               PHONE NO : 650 636 8117   
6000 SHORELINE COURT SUITE 101    SE DECISION MADE: 10-APR-14
SOUTH SAN FRANCISCO CA 94080      510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME
LEMAITRE VASCULAR, INC.           510(k) NO: K140042(TRADITIONAL)
ATTN: BRYAN  COWELL               PHONE NO : 781 425 1727   
63 SECOND AVENUE                  SE DECISION MADE: 10-APR-14
BURLINGTON MA 01803               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ONTEX AND OTHERS PROPRIETARY NAMES
ONTEX BVBA                        510(k) NO: K132208(TRADITIONAL)
ATTN: RACHEL  PAUL                PHONE NO : 317 034585 70
PRINSESSEGRACHT 20                SE DECISION MADE: 10-APR-14
THE HAGUE    NL 2514AP            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: POWDERED VINYL EXAMINATION GLOVES
SHU TONG XINGHUA CO., LTD.        510(k) NO: K122176(TRADITIONAL)
ATTN: SU SONG  SHI                PHONE NO : 008 652 383495619
WEST OF XI HUAN ROAD ECONOMIC DEVESE DECISION MADE: 11-APR-14
XINGHUA    CH 225700              510(k) STATEMENT
 
DEVICE: POWDER FREE VINYL EXAMINATION GLOVES
SHU TONG XINGHUA CO., LTD.        510(k) NO: K122377(TRADITIONAL)
ATTN: SU  SONG SHI                PHONE NO : 008 652383 495619
WEST OF XI HUAN ROAD ECONOMIC DEVESE DECISION MADE: 11-APR-14
XINGHUA    CH 225700              510(k) STATEMENT
 
DEVICE: RENOVIS TESERA TRABECULAR TECHNOLOGY (T3) ACETABULAR SHELL SYSTEM
RENOVIS SURGICAL TECHNOLOGIES, LLC510(k) NO: K132312(TRADITIONAL)
ATTN: SHARYN  ORTON, PH.D.        PHONE NO : 401 330 8264   
200 HOMER AVE                     SE DECISION MADE: 11-APR-14
ASHLAND MA 01721                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PROPOSED OPTIMUS
CUSTOM SPINE, INC.                510(k) NO: K132596(TRADITIONAL)
ATTN: HANAA  SHAHIN               PHONE NO : 973 808 0019   
9 Campus Dr                       SE DECISION MADE: 11-APR-14
PARSIPPANY NJ 07054               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD), SCANWAVE PEN (WITH DARK GRAY CORD), SCANWAVE
SATELEC-ACTEON GROUP              510(k) NO: K131906(ABBREVIATED)
ATTN: RICK  ROSATI                PHONE NO : 800 289 6367   
124 GAITHER DRIVE , SUITE 140     SE DECISION MADE: 11-APR-14
MT LAUREL NJ 08054                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ALL-BOND UNIVERSAL SC (NOT FINALIZED)
BISCO, INC.                       510(k) NO: K131734(TRADITIONAL)
ATTN: MICHELLE  SCHILTZ-TAING     PHONE NO : 847 534 6146   
1100 WEST IRVING PARK RD.         SE DECISION MADE: 11-APR-14
SCHAUMBURG IL 60193               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AUDICOR CPAM WITH SDB (ACCELEROMETER BASED)
INOVISE MEDICAL, INC.             510(k) NO: K131883(TRADITIONAL)
ATTN: EARL  ANDERSON              PHONE NO : 503 431 3800   
8770 SW NIMBUS AVENUE SUITE D     SE DECISION MADE: 11-APR-14
BEAVERTON OR 97008 7196           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AIR-FLOW HANDY 3.0
E.M.S. ELECTRO MEDICAL SYSTEMS S.A510(k) NO: K132478(TRADITIONAL)
ATTN: CYNTHIA J NOLTE             PHONE NO : 919 859 4207   
62 FOREST ST., STE 300            SE DECISION MADE: 11-APR-14
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RHYTHMLINK DISPOSABLE CONCENTRIC STIMULATING PROBE
RHYTHMLINK INTERNATIONAL, LLC     510(k) NO: K132138(TRADITIONAL)
ATTN: JAMES M MEWBORNE            PHONE NO : 803 252 1222   
1140 FIRST STREET SOUTH           SE DECISION MADE: 11-APR-14
COLUMBIA SC 29209                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: REVEEL ENDOSCOPIC RETRACTOR
RETRACTION LIMITED                510(k) NO: K133345(TRADITIONAL)
ATTN: STUART  MORAN               PHONE NO : 852 311 06011
UNIT F, 2/F, HONG KONG INDUSTRIAL SE DECISION MADE: 11-APR-14
SAI WAN, HONG KONG    CH 999077   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: INION FREEDOMPIN
INION OY                          510(k) NO: K133932(TRADITIONAL)
ATTN: KATI  MARTTINEN             PHONE NO : 358 108306 600
LAAKARINKATU 2                    SE DECISION MADE: 11-APR-14
TAMPERE    FI 33520               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOICAL FORCEPS
INTEGRA LIFESCIENCES CORPORATION  510(k) NO: K134047(TRADITIONAL)
ATTN: RUTHANNE  VENDY             PHONE NO : 717 840 3527   
589 DAVIES DRIVE                  SE DECISION MADE: 11-APR-14
YORK PA 17402                     510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SPINEWORKS ANTERIOR LUMBAR DEVICE
SPINEWORKS, LLC                   510(k) NO: K133340(TRADITIONAL)
ATTN: ROBERT  POGGIE, PHD         PHONE NO : 973 738 6097   
815 IRIS LANE                     SE DECISION MADE: 11-APR-14
VERO BEACH FL 32963               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DECLIPSESPECT LAPAROSCOPY
SURGICEYE GMBH                    510(k) NO: K133781(TRADITIONAL)
ATTN: MORITZ  HOYER               PHONE NO : 49 895499 89024
FRIEDENSTRASSE 18A                SE DECISION MADE: 11-APR-14
MUNICH, BAVARIA    GM 81671       510(k) STATEMENT
 
DEVICE: REVOLUTION CT
GE MEDICAL SYSTEMS, LLC           510(k) NO: K133705(TRADITIONAL)
ATTN: HELEN  PENG                 PHONE NO : 262 424 8222   
3000 N GRANDVIEW BLVD.            SE DECISION MADE: 11-APR-14
WAUKESHA WI 53188                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: M-PM-DISC
MERZ DENTAL GMBH                  510(k) NO: K134015(TRADITIONAL)
ATTN: RICHARD G HUNTER            PHONE NO : 505 400 4992   
5616 MARIOLA PL NE                SE DECISION MADE: 11-APR-14
ALBUQUERQUE NM 87111              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER WITH TABLET
REFLECTANCE MEDICAL INC           510(k) NO: K133923(TRADITIONAL)
ATTN: NANDINI  MURTHY             PHONE NO : 781 710 5378   
116 FLAUNDERS ROAD, SUITE 1000    SE DECISION MADE: 11-APR-14
WESTBOROUGH MA 01581              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: GIBRALT ROD-TO-ROD CROSS CONNECTORS
EXACTECH SARASOTA                 510(k) NO: K140645(SPECIAL)
ATTN: PATRICK  HUGHES             PHONE NO : 352 327 4762   
7455 16th Street East Suite 105   SE DECISION MADE: 11-APR-14
Sarasota FL 34243                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DIGITAL FLAT PANEL X-RAY DETECTOR / 1717G, XMARU1717G
RAYENCE CO., LTD                  510(k) NO: K140646(SPECIAL)
ATTN: DAVE  KIM                   PHONE NO : 713 467 2607   
8310 BUFFALO SPEEDWAY             SE DECISION MADE: 11-APR-14
HOUSTON TX 77025                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AZE PHOENIX SOFTWARE
AZE, LTD.                         510(k) NO: K133521(TRADITIONAL)
ATTN: KARL  DIEDRICH, AZE         PHONE NO : 617 475 1502
1-8-1 MARUNOUCHI, CHIYODA-KU      SE DECISION MADE: 11-APR-14
TOKYO    JA 100-0005              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: ERCHONIA ALLAY
ERCHONIA MEDICAL, INC.            510(k) NO: K132940(TRADITIONAL)
ATTN: KEVIN  WALLS                PHONE NO : 720 962 5412   
33 GOLDEN EAGLE LANE              SE DECISION MADE: 14-APR-14
LITTLETON CO 80127                510(k) STATEMENT
 
DEVICE: DISCOSCOPES, CERVICAL ENDOSCOPES
RZ MEDIZINTECHNIK GMBH            510(k) NO: K130778(TRADITIONAL)
ATTN: ANDRE  WEINGREL             PHONE NO : 49 7463 99540
GRIESWEG 47                       SE DECISION MADE: 14-APR-14
MUEHLHEIM, BADEN-WUERTTEMBERG    G510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AVANCE® FOAM ABDOMINAL DRESSING KIT
MOLNLYCKE HEALTHCARE              510(k) NO: K130852(TRADITIONAL)
ATTN: ANGELA L BUNN               PHONE NO : 678 250 7930   
5550 PEACHTREE PARKWAY SUITE 500  SE DECISION MADE: 14-APR-14
NORCROSS GA 30092                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CERVICAL STAND ALONE SYSTEM
ORTHOFIX INC.                     510(k) NO: K132999(TRADITIONAL)
ATTN: NATALIA  VOLOSEN            PHONE NO : 214 937 2145   
3451 PLANO PARKWAY                SE DECISION MADE: 14-APR-14
LEWISVILLE TX 75056               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MYHEALTHPOINT TELEHEALTH MANAGER
ENTRA HEALTH SYSTEMS              510(k) NO: K132930(TRADITIONAL)
ATTN: RICHARD  STROBRIDGE         PHONE NO : 877 458 2646   
3111 Camino Del Rio North Suite 10SE DECISION MADE: 14-APR-14
San Diego CA 92108                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PICASSO II MIS SPINAL SYSTEM
ACCEL SPINE                       510(k) NO: K140219(SPECIAL)
ATTN: LISA  PETERSON              PHONE NO : 512 507 0746   
14001 HUNTERS PASS                SE DECISION MADE: 14-APR-14
AUSTIN TX 78734                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE
GALEMED CORP.                     510(k) NO: K133957(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498215 5
AMOY EXPORT PROCESSING ZONE, 39 SESE DECISION MADE: 14-APR-14
XIAMEN, FUJIAN    CH 361000       510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CABOCHON SYSTEM
CABOCHON AESTHETICS, INC.         510(k) NO: K134010(TRADITIONAL)
ATTN: BEN F BRIAN, PH.D.          PHONE NO : 650 543 7110   
127 INDEPENDENCE DRIVE            SE DECISION MADE: 14-APR-14
MENLO PARK CA 94025               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ELISIO-H HEMODIALYZER
NIPRO MEDICAL CORPORATION         510(k) NO: K140191(SPECIAL)
ATTN: CAROLYN  GEORGE             PHONE NO : 305 599 7174   
3150 NW 107 AVE.,                 SE DECISION MADE: 14-APR-14
MIAMI FL 33172                    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NAMIC RCS SYRINGE
NAVILYST MEDICAL, INC.            510(k) NO: K140194(ABBREVIATED)
ATTN: BRANDON M BRACKETT          PHONE NO : 508 658 7984   
26 FOREST STREET                  SE DECISION MADE: 14-APR-14
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: COGENT MED-LIF
COGENT SPINE LLC                  510(k) NO: K132738(TRADITIONAL)
ATTN: JUDE  PAGANELLI             PHONE NO : 858 774 7891   
101 N. ACACIA AVE SUITE 106       SE DECISION MADE: 15-APR-14
SOLANA BEACH CA 92075             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MAXZERO EXTENSION SET WITH NEEDLESS CONNECTOR
CAREFUSION                        510(k) NO: K140831(TRADITIONAL)
ATTN: LARRY  WALKER               PHONE NO : 
10020 PACIFIC MESA BLVD           SE DECISION MADE: 15-APR-14
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: FLEXIVA SF SIDE-FIRING SINGLE-USE LASER FIBER
BOSTON SCIENTIFIC                 510(k) NO: K140503(TRADITIONAL)
ATTN: JEANNE  O'TOOLE             PHONE NO : 508 683 4271   
100 BOSTON SCIENTIFIC WAY         SE DECISION MADE: 15-APR-14
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: 6200 / 6250 ULTRASOUND SYSTEM
ESAOTE S.P.A.                     510(k) NO: K133905(TRADITIONAL)
ATTN: ALLISON  SCOTT              PHONE NO : 317 228 8719   
9001 WESLEYAN ROAD, SUITE 200     SE DECISION MADE: 15-APR-14
INDIANAPOLIS IN 46268             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EM40 SELF-MONITORING BLOOD GLUCOSE SYSTEM
EPS BIO TECHNOLOGY CORP.          510(k) NO: K133389(SPECIAL)
ATTN: CYNTHIA  HUNG               PHONE NO : 886 3 6686868
NO.8 R&D RD III HSINCHU SCIENCE PASE DECISION MADE: 15-APR-14
HSINCHU CITY,    TW 30077         510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV KYPHOPLASTY CATHETER (BALLOON LENGHT: 15 MM), INTERV KYPHOPL
PAN MEDICAL LTD                   510(k) NO: K132620(TRADITIONAL)
ATTN: JENNIE  BUDDING             PHONE NO : 44 1452 621621
BARNETT WAY, BARNWOOD             SE DECISION MADE: 16-APR-14
GLOUCESTER, GLOUCESTERSHIRE    UK 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ORA 0.4MM [S], ORA 1.0MM [S], ORA 2.0MM [S], ORA 3.0MM [S], ORA 4.0MM [S]
STERNGOLD DENTAL LLC              510(k) NO: K133791(ABBREVIATED)
ATTN: MARIA  RAO                  PHONE NO : 508 556 5660   
23 FRANK MOSSBERG DRIVE           SE DECISION MADE: 16-APR-14
ATTLEBORO MA 02703 0967           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CURRIE MEDICAL REPROCESSED ALP CALF/THIGH/FOOT COMPRESSION SLEEVE (ALL SIZES)
CURRIE MEDICAL SPECIALTIES, INC.  510(k) NO: K140092(TRADITIONAL)
ATTN: OWEN J BRY                  PHONE NO : 909 912 0900   
8758 Hellman Ave                  SE DECISION MADE: 16-APR-14
Rancho Cucamonga CA 91730         510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AMERIWATER CENTURION 1500+ REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION
AMERIWATER                        510(k) NO: K133783(TRADITIONAL)
ATTN: BRIAN R BOWMAN              PHONE NO : 937 461 8833   
1303 STANLEY AVE.                 SE DECISION MADE: 16-APR-14
DAYTON OH 45404                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ROTATING ADAPTERS
MERIT MEDICAL SYSTEMS, INC.       510(k) NO: K140475(TRADITIONAL)
ATTN: CORY  MARSH                 PHONE NO : 801 316 3690   
1600 WEST MERIT PKWY.             SE DECISION MADE: 16-APR-14
SOUTH JORDAN UT 84095             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: INSERTION TOOL
BOSTON SCIENTIFIC CORP.           510(k) NO: K140673(SPECIAL)
ATTN: LISA  MEE                   PHONE NO : 763 494 1185   
ONE SCIMED PLACE                  SE DECISION MADE: 16-APR-14
MAPLE GROVE MN 55311              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: INTESS CERVICAL CAGE SYSTEM
KALITEC DIRECT, LLC               510(k) NO: K133815(TRADITIONAL)
ATTN: J.D.  WEBB                  PHONE NO : 512 388 0199   
1001 OAKWOOD BLVD                 SE DECISION MADE: 16-APR-14
ROUND ROCK TX 78681               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TRUEPATH CTO DEVICE
BOSTON SCIENTIFIC CORP.           510(k) NO: K140288(SPECIAL)
ATTN: CAROL  TIFFANY              PHONE NO : 
ONE SCIMED PLACE                  SE DECISION MADE: 16-APR-14
MAPLE GROVE MN 55311              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SAGE 1-STEP WITH HUMAN SERUM ALBUMIN, SAGE 1-STEP WITH SERUM PROTEIN SUPPLEMENTS
ORIGIO A/S                        510(k) NO: K133707(TRADITIONAL)
ATTN: TOVE  KJAER                 PHONE NO : 45 4679 0200
Knardrupvej 2                     SE DECISION MADE: 16-APR-14
Maaloev    DA 2760                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PROSOUND F75  DIAGNOSTIC ULTRASOUND SYSTEM
HITACHI ALOKA MEDICAL, LTD.       510(k) NO: K140639(TRADITIONAL)
ATTN: ANGELA  VANARSDALE          PHONE NO : 203 269 5088   
10 FAIRFIELD BLVD.                SE DECISION MADE: 16-APR-14
WALLINGFORD CT CT 06492 7502      510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PVMED DDR 2430T
PORTAVISION MEDICAL LLC           510(k) NO: K133524(TRADITIONAL)
ATTN: TERRY  ANCAR                PHONE NO : 866 783 4133   
5401 COCOS PLUMOSAS DRIVE         SE DECISION MADE: 16-APR-14
KENNER LA 70065                   510(k) STATEMENT
 
DEVICE: ADVATX
ADVALIGHT APS                     510(k) NO: K132976(TRADITIONAL)
ATTN: MAUREEN  O'CONNELL          PHONE NO : 978 207 1245   
5 TIMBER LANE                     SE DECISION MADE: 17-APR-14
NORTH READING MA 01864            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NEOV DIODE LASER FAMILY
G.N.S NEOLASER LTD.               510(k) NO: K133006(TRADITIONAL)
ATTN: GIL  SHAPIRA                PHONE NO : 972 467 79919
7 HA'ESHEL STR                    SE DECISION MADE: 17-APR-14
CAESAREA    IS 38900              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SMART (SMART-D, SMART-DX)
BTS SPA                           510(k) NO: K131660(TRADITIONAL)
ATTN: ENRICO  BISSON              PHONE NO : 39 049981 5500
VIA CROCE ROSSA, 11               SE DECISION MADE: 17-APR-14
PADOVA    IT 35129                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: HC-1 AND HC-1 CLASSIC
TRANSCENDENCIAS COMERCIALES SL TRA510(k) NO: K131852(TRADITIONAL)
ATTN: RAMON  ECHEVARRIA           PHONE NO : 34 943 224360
C/ZUBIBERRI 31- PLANTA BAJA LOCAL SE DECISION MADE: 17-APR-14
SAN SEBASTIAN, GUIPUZCOA    SP 200510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS)
MONARCH MEDICAL TECHNOLOGIES      510(k) NO: K132547(ABBREVIATED)
ATTN: ANN A GRAHAM                PHONE NO : 240 476 3477   
3457 CHISWICK COURT               SE DECISION MADE: 17-APR-14
SILVER SPRING MD 20906            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: Q-STATION
PHILIPS ULTRASOUND, INC.          510(k) NO: K140808(TRADITIONAL)
ATTN: PENNY  GRECO                PHONE NO : 
3000 MINUTEMAN RD.                SE DECISION MADE: 17-APR-14
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH)
BECKMAN COULTER, INC.             510(k) NO: K131189(TRADITIONAL)
ATTN: YVETTE  LLOYD               PHONE NO : 714 307 3469   
250 S. KRAEMER ST                 SE DECISION MADE: 17-APR-14
BREA CA 92821                     510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: LEVEEN STANDARD NEEDLE ELECTRODE, LEVEEN COACCESS NEEDLE ELECTRODE
BOSTON SCIENTIFIC CORP.           510(k) NO: K140495(TRADITIONAL)
ATTN: MATT  BEAUCHANE             PHONE NO : 763 494 1789   
ONE SCIMED PLACE                  SE DECISION MADE: 17-APR-14
MAPLE GROVE MN 55311              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DESTINO TWIST, STEERABLE GUIDING SHEATH
OSCOR INC.                        510(k) NO: K140406(SPECIAL)
ATTN: TINA  STRICKLAND            PHONE NO : 727 937 2511   
3816 DE SOTO BLVD.                SE DECISION MADE: 17-APR-14
PALM HARBOR FL 34683              510(k) STATEMENT
 
DEVICE: STRAUMANN MAGELLAN(TM) ABUTMENT,PROTECTIVE CAP,TITANIUM COPINGS,GOLD CHOPINGS,BASAL SCREW
STRAUMANN USA, LLC                510(k) NO: K133421(TRADITIONAL)
ATTN: CHARLOTTE  RINGLEB          PHONE NO : 978 747 2552   
60 MINUTEMAN ROAD                 SE DECISION MADE: 17-APR-14
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AIS MODULIFT VBR SYSTEM
AESCULAP IMPLANT SYSTEM, INC.     510(k) NO: K133802(TRADITIONAL)
ATTN: LISA M BOYLE                PHONE NO : 610 984 9274   
3773 CORPORATE PWKY.              SE DECISION MADE: 17-APR-14
CENTER VALLEY PA 18034            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PARALOCK PLATING SYSTEM / TUFFNEK SCREW
PARAGON 28                        510(k) NO: K140397(TRADITIONAL)
ATTN: KAREN E WARDEN              PHONE NO : 440 729 8457   
P O BOX 566                       SE DECISION MADE: 17-APR-14
CHESTERLAND OH 44026 0566         510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FLIP INTRODUCER ACCESS KIT
VASCULAR SOLUTIONS, INC.          510(k) NO: K132789(TRADITIONAL)
ATTN: ELLIE  GILLESPIE            PHONE NO : 763 656 4300   
6464 SYCAMORE COURT NORTH         SE DECISION MADE: 17-APR-14
MINNEAPOLIS MN 55369              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VARIAX 2 SYSTEM
STRYKER TRAUMA AG                 510(k) NO: K140769(SPECIAL)
ATTN: ELIJAH N WREH               PHONE NO : 201 831 5691   
325 CORPORATE ARIVE               SE DECISION MADE: 17-APR-14
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM
BIONIME COPORATION                510(k) NO: K133522(TRADITIONAL)
ATTN: FENG-YU  LEE                PHONE NO : 949 951 3046   
2700 LA PAZ ROAD SUITE 266B       SE DECISION MADE: 17-APR-14
MISSION VIEJO CA 92691            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SOMATOM FORCE
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K133589(TRADITIONAL)
ATTN: KIMBERLY  MANGUM            PHONE NO : 610 448 4912   
51 VALLEY STREAM PKWY.            SE DECISION MADE: 17-APR-14
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: INITARY BETTER BLADDER-PEDIATRIC
CIRCULATORY TECHNOLOGY, INC.      510(k) NO: K140321(SPECIAL)
ATTN: YEHUDA  TAMARI              PHONE NO : 516 624 2424   
21 SINGWORTH ST.                  SE DECISION MADE: 17-APR-14
OYSTER BAY NY 11771               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ZIP MIS INTERSPINOUS FUSION SYSTEM
AURORA SPINE, INC.                510(k) NO: K140715(SPECIAL)
ATTN: JUSTI N  EGGLETON           PHONE NO : 202 552 5800   
1331 H STREET NW 12TH FLOOR       SE DECISION MADE: 17-APR-14
WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NUFACE MINI DEVICE
CAROL COLE COMPANY                510(k) NO: K133823(ABBREVIATED)
ATTN: RAND  DAOUD                 PHONE NO : 760 734 4545   
1325 Sycamore Ave Ste A           SE DECISION MADE: 17-APR-14
Vista CA 92081                    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ERGONOMIC PRODUCTS WORKSTATION
ERGONOMIC PRODUCTS, INC.          510(k) NO: K132315(TRADITIONAL)
ATTN: RENEE  GOULD                PHONE NO : 401 651 6513   
240 ANNETTE AVE                   SE DECISION MADE: 18-APR-14
WOONSOCKET RI 02895               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ANYPLUS; ALIF PEEK CAGES, PLIF PEEK CAGES, T-PLIF PEEK CAGES, TLIF PEEK CAGES
GS MEDICAL CO., LTD.              510(k) NO: K131612(TRADITIONAL)
ATTN: DONALD W GUTHNER            PHONE NO : 646 460 2984   
111 HILL ROAD                     SE DECISION MADE: 18-APR-14
DOUGLASSVILLE PA 19518            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PASSPORT M SERIES PATIENT MONITORING (INCLUDING MODELS PASSPORT 17M AND PASSPORT 12M)
MINDRAY NORTH AMERICA             510(k) NO: K132075(ABBREVIATED)
ATTN: RUSSELL  OLSEN              PHONE NO : 201 995 8391   
800 MACARTHUR BLVD                SE DECISION MADE: 18-APR-14
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: COMPASS CT, COMPASS CT PORT
MIRADOR BIOMEDICAL                510(k) NO: K133624(TRADITIONAL)
ATTN: JUSTIN  HULVERSHORN         PHONE NO : 206 295 3372   
2815 EASTLAKE AVE E SUITE 220     SE DECISION MADE: 18-APR-14
SEATTLE WA 98102                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MASTERGRAFT PUTTY, MASTERGRAFT STRIP
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K140375(TRADITIONAL)
ATTN: KELLY  ANGLIN               PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 18-APR-14
Memphis TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MITEK ARTHROSCOPES
MEDOS INTERNATIONAL SARL          510(k) NO: K133941(TRADITIONAL)
ATTN: SUSAN  KAGAN                PHONE NO : 508 880 8097
CHEMIN-BLANC 38, CASE POSTALE     SE DECISION MADE: 18-APR-14
LE LOCLE    SZ CH 2400            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: GENTLECARE AR APPLICATOR
GC MEDTECH, LLC                   510(k) NO: K133922(TRADITIONAL)
ATTN: GREGORY  MATHISON           PHONE NO : 218 387 1559   
3924 CASCADE BEACH ROAD           SE DECISION MADE: 18-APR-14
LUTSEN MN 55612                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ANGIOSCULPT PTA SCORING BALLOON WITH HYDROCROSS CAOTING
ANGIOSCORE, INC.                  510(k) NO: K133998(TRADITIONAL)
ATTN: KIMBERLEY  KLINE            PHONE NO : 510 933 7989   
5055 BRANDIN COURT                SE DECISION MADE: 18-APR-14
FREMONT CA 94538                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: GALAXY CO2 LASER SYSTEM
BEIJING TOPLASER TECHNOLOGY CO., L510(k) NO: K133915(TRADITIONAL)
ATTN: ZHANG  XIAOSONG             PHONE NO : 86 106435 4759
EAST 3RD FL, BLDG M7 # 1 JIUXIANQISE DECISION MADE: 18-APR-14
CHAOYANG DISTRICT, BEIJING    CH 1510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ORTHOSORB LS
BIOMET, INC.                      510(k) NO: K140625(TRADITIONAL)
ATTN: VICTORIA  SCHEITLIN         PHONE NO : 574 372 6801   
56 EAST BELL DR.                  SE DECISION MADE: 18-APR-14
WARSAW IN 46581 0587              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: JULIET OL
SPINEART                          510(k) NO: K140474(TRADITIONAL)
ATTN: FRANK  PENNESI              PHONE NO : 41 22 7994025
INTERNATIONAL CENTER COINTRIN 20 RSE DECISION MADE: 18-APR-14
GENEVA    SZ 1215                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY
COOK, INC.                        510(k) NO: K133597(TRADITIONAL)
ATTN: SEAN  SPENCE                PHONE NO : 812 335 3575   
750 DANIELS WAY                   SE DECISION MADE: 18-APR-14
BLOOMINGTON IN 47404              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: P-POD
P-POD                             510(k) NO: K133397(TRADITIONAL)
ATTN: LINDA  BRADDON              PHONE NO : 770 837 2681   
7828 HICKORY FLAT HWY. SUITE 120  SE DECISION MADE: 18-APR-14
WOODSTOCK GA 30188                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MCKESSON CARDIOLOGY ECG MOBILE
MCKESSON ISRAEL LTD.              510(k) NO: K133534(TRADITIONAL)
ATTN: PAUL  SUMNER                PHONE NO : 404 338 3556   
5995 WINDWARD PARKWAY             SE DECISION MADE: 18-APR-14
ALPHARETTA GA 30005               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ENVOY GUIDING CATHETER
CODMAN & SHURTLEFF, INC.          510(k) NO: K140307(SPECIAL)
ATTN: HANNAH  FOLEY               PHONE NO : 305 265 6810   
325 PARAMOUNT DR.                 SE DECISION MADE: 21-APR-14
RAYNHAM MA 02767 0350             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ALAMO T
ALLIANCE PARTNERS, LLC.           510(k) NO: K140303(SPECIAL)
ATTN: KELLEN  HILLS               PHONE NO : 901 433 1990   
4600 E SHELBY DR                  SE DECISION MADE: 21-APR-14
MEMPHIS TN 38118                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA
CAREFUSION 2200 INC.              510(k) NO: K140761(SPECIAL)
ATTN: JANE  WEBER                 PHONE NO : 847 362 8094   
72 N. FAIRWAY DRIVE               SE DECISION MADE: 21-APR-14
VERNON HILLS IL 60061             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: INSTINCT; PLAIN, DOTTED, ULTRA THIN
PROFILATEX, S.A. DE C.V.          510(k) NO: K132390(ABBREVIATED)
ATTN: JUAN ERNESTO  DE LA PUENTE  PHONE NO : 52 555975 6060
FEBRERO DE 1917 #4 COL. CIPRESES  SE DECISION MADE: 22-APR-14
CHALCO    MX 56600                510(k) STATEMENT
 
DEVICE: HEPATIC VCAR
GE MEDICAL SYSTEMS SCS            510(k) NO: K133649(TRADITIONAL)
ATTN: HUY  DOAN                   PHONE NO : 262 312 7751   
3000 N. GRANDVIEW                 SE DECISION MADE: 22-APR-14
WAUKESHA WI 53188                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM V4.0
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K133761(TRADITIONAL)
ATTN: CHARLEMAGNE  CHUA           PHONE NO : 714 669 7896   
2441 MICHELLE DRIVE               SE DECISION MADE: 22-APR-14
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MEDSOURCE SELECTABLE IV SET
MEDSOURCE INTERNATIONAL, LLC.     510(k) NO: K140442(SPECIAL)
ATTN: JENNIFER  NESS              PHONE NO : 952 241 8318   
5346 SHORELINE DR.                SE DECISION MADE: 22-APR-14
MOUND MN 55364                    510(k) STATEMENT
 
DEVICE: ECHELON FLEX POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60MM, STANDARD, ECHELON FLEX POWERED PLUS ARTICULATING
ETHICON ENDO-SURGERY, LLC         510(k) NO: K140560(TRADITIONAL)
ATTN: ASIFA  VONHOF               PHONE NO : 513 337 3118   
4545 CREEK ROAD                   SE DECISION MADE: 22-APR-14
CINCINNATI OH 45242               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BCT ANTIMICROBIAL DRESSING & BCT SILVER BANDAGE
BIO-MEDICAL CARBON TECHNOLOGY CO.,510(k) NO: K140147(TRADITIONAL)
ATTN: DIANE  SUDDUTH              PHONE NO : 512 327 9997   
816 CONGRESS AVE. STE 1400        SE DECISION MADE: 22-APR-14
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HF
VIVONIC GMBH                      510(k) NO: K133829(TRADITIONAL)
ATTN: ANDREAS  HESSBERGER         PHONE NO : 49 6093 971311
KURFUERST-EPPSTEIN-RING 4         SE DECISION MADE: 22-APR-14
SAILAUF    GM 63877               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ACCUTIP COVER
ACCUTOME, INC.                    510(k) NO: K132549(TRADITIONAL)
ATTN: ADAM  PICKHOLTZ             PHONE NO : 610 889 0200   
3222 PHOENIXVILLE PIKE            SE DECISION MADE: 23-APR-14
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS
ONTEX BVBA                        510(k) NO: K132595(TRADITIONAL)
ATTN: RACHEL  PAUL                PHONE NO : 31 70 3458570
PRINSESSEGRACHT 20                SE DECISION MADE: 23-APR-14
THE HAGUE    NL 2514AP            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EUM 100PRO
PROMEDIC, INC.                    510(k) NO: K131889(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DR                 SE DECISION MADE: 23-APR-14
BONITA SPRINGS FL 34134 2958      510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NASAL MASK, NASAL MASK, FULL FACE MASK
BMC MEDICAL CO., LTD              510(k) NO: K133009(TRADITIONAL)
ATTN: MS.  JINJING                PHONE NO : 
5/F Main Building No.19 Gucheng StSE DECISION MADE: 23-APR-14
Beijing    CN 100043              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CENTERVUE MACULAR INTEGRITY ASSESSMENT
CENTERVUE SPA                     510(k) NO: K133758(TRADITIONAL)
ATTN: ROGER  GRAY                 PHONE NO : 39 06 5782665
PIAZZA ALBANIA 10                 SE DECISION MADE: 23-APR-14
ROME    IT 00153                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: XQ-1 INCUBATOR
AT MEDICAL UAB                    510(k) NO: K133742(TRADITIONAL)
ATTN: THOMAS  PEDERSEN            PHONE NO : 004 526340 702
DRAUGYSTES G.19                   SE DECISION MADE: 23-APR-14
KAUNAS    LH 51230                510(k) STATEMENT
 
DEVICE: DEXIS SOFTWARE: DEXIS IMAGING SUITE, DEXIS MAC
IMAGING SCIENCES INTERNATIONAL, LL510(k) NO: K140445(SPECIAL)
ATTN: SANJAY  AHUJA               PHONE NO : 267 954 1463   
1910 NORTH PENN RD.               SE DECISION MADE: 23-APR-14
HATFIELD PA 19440                 510(k) STATEMENT
 
DEVICE: AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM X 10MM STENT)
XLUMENA, INC.                     510(k) NO: K140561(SPECIAL)
ATTN: JANE  BEGGS                 PHONE NO : 650 961 9900   
453 RAVENDALE DRIVE. SUITE H      SE DECISION MADE: 23-APR-14
MOUNTAIN VIEW CA 94043            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FORTRESS PEDICLE SCREW SYSTEM
SPINEOLOGY, INC.                  510(k) NO: K140010(TRADITIONAL)
ATTN: KAREN  ROCHE                PHONE NO : 651 256 8513   
7800 3RD ST NORTH SUITE 600       SE DECISION MADE: 23-APR-14
ST. PAUL MN 55128                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TVC IMAGING SYSTEM, TVC INSIGHT CATHETER
INFRAREDX, INC.                   510(k) NO: K133897(TRADITIONAL)
ATTN: STEVEN J CHARTIER           PHONE NO : 781 345 9593   
34 THIRD AVE                      SE DECISION MADE: 23-APR-14
BURLINGTON MA 01803               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DISCOVERY IGS 740
GE MEDICAL SYSTEMS SCS            510(k) NO: K133278(TRADITIONAL)
ATTN: MICHEL  GENUER              PHONE NO : 33 13070 4741
283 RUE DE LA MINIERE             SE DECISION MADE: 24-APR-14
BUC    FR 78530                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
DEFIBTECH, LLC                    510(k) NO: K131525(TRADITIONAL)
ATTN: ED  HORTON                  PHONE NO : 203 453 6654   
741 BOSTON POST ROAD,SUITE 201    SE DECISION MADE: 24-APR-14
GUILFORD CT 06437                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NEURAGEN 3D
INTEGRA LIFESCIENCES CORPORATION  510(k) NO: K130557(TRADITIONAL)
ATTN: STEPHEN H BEIER             PHONE NO : 609 936 5436   
311 ENTERPRISE DR.                SE DECISION MADE: 24-APR-14
PLAINSBORO NJ 08536               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PINOOK MASSAGER
PINOOK USA                        510(k) NO: K132563(TRADITIONAL)
ATTN: TEJAS  SHAH                 PHONE NO : 858 657 9226   
5703 OBERLIN DRIVE STE 306        SE DECISION MADE: 24-APR-14
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DIODE LASER FOR HIAR REMOVAL
BEIJING HONKON TECHNOLOGIES CO., L510(k) NO: K131838(TRADITIONAL)
ATTN: MIKE  GU                    PHONE NO : 86 206232 1333
7TH FL. JINGGUI BUSINESS BLDG NO. SE DECISION MADE: 24-APR-14
GUANGZHOU, GUANGDONG    CH 510420 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ELECTRIC BREAST PUMP
SHANTOU XINGHE ELECTRICAL APPARATU510(k) NO: K132882(TRADITIONAL)
ATTN: MIKE  GU                    PHONE NO : 86 206232 1333
7TH FLOOR, JINGUI BUSINESS BLDG, NSE DECISION MADE: 24-APR-14
GUANGZHOU, GUANGDONG    CH 510420 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DX3000-L
DEXCOWIN CO., LTD                 510(k) NO: K133007(SPECIAL)
ATTN: CLAUDE  BERTHOIN            PHONE NO : 386 672 0450   
110 EAST GRANADA BLVD. SUITE 207  SE DECISION MADE: 24-APR-14
ORMOND BEACH FL 32176             510(k) STATEMENT
 
DEVICE: ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
ACCLARENT, INC.                   510(k) NO: K132433(TRADITIONAL)
ATTN: JAMES  PATRICK GARVEY II    PHONE NO : 650 687 4807   
1525-B OBRIEN DR.                 SE DECISION MADE: 24-APR-14
MENLO PARK CA 94025               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: QUICK RELAX PRO
HEALTHCARE INNOVATIONS, LLC       510(k) NO: K131956(TRADITIONAL)
ATTN: SHEPARD G BENTLEY, RAC      PHONE NO : 949 374 9187   
28241 CROWN VALLEY PKWY, STE 510(KSE DECISION MADE: 24-APR-14
LAGUNA NIGUEL CA 92677            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB
CODMAN & SHURTLEFF, INC.          510(k) NO: K140080(SPECIAL)
ATTN: HANNAH  FOLEY               PHONE NO : 305 265 6810   
325 PARAMOUNT DR.                 SE DECISION MADE: 24-APR-14
RAYNHAM MA 02767 0350             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: POLARIS SPINAL SYSTEM -TRANSLATION SCREW
EBI, LLC                          510(k) NO: K140123(TRADITIONAL)
ATTN: MIKE  MEDINA                PHONE NO : 303 501 8548   
399 Jefferson Rd                  SE DECISION MADE: 24-APR-14
PARSIPPANY NJ 07054               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FLUID LEVEL MONITOR
COLEMAN LABORATORIES              510(k) NO: K133870(TRADITIONAL)
ATTN: LE-JUN  YIN                 PHONE NO : 484 727 8812   
1150 FIRST AVENUE, SUITE 501      SE DECISION MADE: 24-APR-14
KING OF PRUSSIA PA 19406          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MONOFILAMENT POLYPECTOMY SNARE
UNITED STATES ENDOSCOPY           510(k) NO: K140763(SPECIAL)
ATTN: SAGAR D PIMPALWAR           PHONE NO : 440 358 6265   
5976 HEISLEY ROAD                 SE DECISION MADE: 24-APR-14
MENTOR OH 44060                   510(k) STATEMENT
 
DEVICE: LYPHOCHEK ALLERGEN SIGE  CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL, NEGATIVE MINIPAK, LYPHOCHEK ALLERGEN SIGE CO
BIO-RAD LABORATORIES              510(k) NO: K134013(TRADITIONAL)
ATTN: SUZANNE  PARSONS            PHONE NO : 949 598 1467   
9500 JERONIMO RD.                 SE DECISION MADE: 24-APR-14
IRVINE CA 92618 2017              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: COUNTER OTC TENS DEVICE
COUNTER SCIENTIFIC DEVELOPMENT (GZ510(k) NO: K132993(TRADITIONAL)
ATTN: GUENTER  GINSBERG           PHONE NO : 239 948 2001   
11820 RED HIBISCUS DRIVE          SE DECISION MADE: 24-APR-14
BONITA SPRINGS FL 34135           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUS
PENTAX MEDICAL COMPANY            510(k) NO: K131946(TRADITIONAL)
ATTN: KRISHNA  GOVINDARAJAN       PHONE NO : 800 431 5880   
3 Paragon Drive                   SE DECISION MADE: 25-APR-14
MONTVALE NJ 07645 1782            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: OCTANE ELEVATE SPINAL IMPLANT SYSTEM
EXACTECH, INC.                    510(k) NO: K123607(TRADITIONAL)
ATTN: PATRICK  HUGHES             PHONE NO : 352 327 4762   
2320 N.W. 66TH CT.                SE DECISION MADE: 25-APR-14
GAINESVILLE FL 32653              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: GEL-BEAD EMBOLIZATION SPHERES
VASCULAR SOLUTIONS, INC.          510(k) NO: K133237(TRADITIONAL)
ATTN: ELLIE  GILLESPIE            PHONE NO : 763 656 4300   
6464 SYCAMORE COURT NORTH         SE DECISION MADE: 25-APR-14
MINNEAPOLIS MN 55369              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: THE MOSES ELITE APPLIANCE
ALLEN J. MOSES, DDS, LTD.         510(k) NO: K132933(SPECIAL)
ATTN: ALLEN J MOSES, DDS          PHONE NO : 312 993 0430   
233 S. WACKER DR.                 SE DECISION MADE: 25-APR-14
CHICAGO IL 60606                  510(k) STATEMENT
 
DEVICE: MTA FILLAPEX
ANGELUS INDUSTRIA DE PRODUCTOS ODO510(k) NO: K140247(SPECIAL)
ATTN: TARA  CONRAD                PHONE NO : 305 377 0077   
18851 NE 29TH AVE 720             SE DECISION MADE: 25-APR-14
AVENTURA FL 33180                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ZIMMER ZFX TITANIUM ABUTMENT, BASE ABUTMENT AND ABUTMENT BLANK FOR NOBELACTIVE IMPLANT SYSTEM
ZIMMER DENTAL INC.                510(k) NO: K134045(TRADITIONAL)
ATTN: JULIE  LAMOTHE              PHONE NO : 760 929 4300   
1900 ASTON AVE.                   SE DECISION MADE: 25-APR-14
CARLSBAD CA 92008 7308            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SMARTTOUCH
NEXUS6, LTD.                      510(k) NO: K133951(TRADITIONAL)
ATTN: GARTH  SUTHERLAND           PHONE NO : 64 930727 71
8 COMMERCE STREET SUITE 205       SE DECISION MADE: 25-APR-14
AUCKLAND    NZ 1010               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: INFLUENZA A SUBTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
CENTERS FOR DISEASE CONTROL AND PR510(k) NO: K140851(SPECIAL)
ATTN: CDR YON  YU, PHARM.D.       PHONE NO : 404 639 3046   
1600 CLIFTON  ROAD, MAILSTOP D-30 SE DECISION MADE: 25-APR-14
ATLANTA GA 30333                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
CENTERS FOR DISEASE CONTROL AND PR510(k) NO: K140857(SPECIAL)
ATTN: CDR YON  YU, PHARM.D.       PHONE NO : 404 639 3046   
1600 CLIFTON  ROAD, MS-C18        SE DECISION MADE: 25-APR-14
ATLANTA GA 30333                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EASY GO VAC
PRECISION MEDICAL, INC.           510(k) NO: K140179(SPECIAL)
ATTN: JAMES  PARKER               PHONE NO : 610 262 6090   
300 HELD DR.                      SE DECISION MADE: 25-APR-14
NORTHAMPTON PA 18067              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MYLABSSOGNO
ESAOTE S.P.A.                     510(k) NO: K140677(TRADITIONAL)
ATTN: ALLISON  SCOTT              PHONE NO : 317 228 8719   
9001 WESLEYAN ROAD, SUITE 200     SE DECISION MADE: 25-APR-14
INDIANAPOLIS IN 46268             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PINIT SMALL BONE FUSION SYSTEM
ARTHROSURFACE, INC.               510(k) NO: K140617(SPECIAL)
ATTN: DAWN J WILSON               PHONE NO : 508 520 3003   
28 FORGE PARKWAY                  SE DECISION MADE: 25-APR-14
FRANKLIN MA 02038                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAK
BIO-RAD LABORATORIES              510(k) NO: K140764(TRADITIONAL)
ATTN: SUZANNE  PARSONS            PHONE NO : 949 598 1467   
9500 JERONIMO RD.                 SE DECISION MADE: 25-APR-14
IRVINE CA 92618 2017              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PHILIPS ELEVA WORKSPOT
PHILIPS MEDICAL SYSTEMS DMC GMBH  510(k) NO: K140771(SPECIAL)
ATTN: GEROLD  SCHWARZ             PHONE NO : 49 405078 1116
ROENTGENSTRASSE 24-26             SE DECISION MADE: 25-APR-14
HAMBURG    GM 22335               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RELIANCE ANTERIOR CERVICAL PLATE
RELIANCE MEDICAL SYSTEMS, LLC     510(k) NO: K140742(SPECIAL)
ATTN: BRET M BERRY                PHONE NO : 801 295 3280   
P.O. BOX 1693                     SE DECISION MADE: 25-APR-14
BOUNTIFUL UT 84010                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: INFINITY TOTAL ANKLE SYSTEM
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K140749(SPECIAL)
ATTN: JEANINE  REDDEN             PHONE NO : 901 867 4522   
1023 CHERRY ROAD                  SE DECISION MADE: 25-APR-14
MEMPHIS TN 38117                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: 2300 SERIES MGO PORTABLE OXYGEN
ULTRA ELECTRONICS LIMITED PRECISIO510(k) NO: K134023(TRADITIONAL)
ATTN: ANDY  CHILTON               PHONE NO : 441 242713 585
ARLE COURT HATHERLEY LANE         SE DECISION MADE: 25-APR-14
CHELTENHAM, GLOUCESTERSHIRE    UK 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FORA CARE BLOOD PRESSURE MONITORING SYSTEM
FORA CARE INC.                    510(k) NO: K133588(TRADITIONAL)
ATTN: SHARON  PENG                PHONE NO : 886 266258 188
6F, NO.127, WUGONG 2ND RD WUGU DISSE DECISION MADE: 25-APR-14
NEW TAIPEI CITY    TW 24888       510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TERASON USMART3400 ULTRASOUND SYSTEM
TERATECH CORP.                    510(k) NO: K140834(TRADITIONAL)
ATTN: BEN  CHIAMPA                PHONE NO : 781 270 4143   
77-79 TERRACE HALL AVE.           SE DECISION MADE: 25-APR-14
BURLINGTON MA 01803               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: ACESSA GUIDANCE HANDPIECE
HALT MEDICAL INC                  510(k) NO: K132184(TRADITIONAL)
ATTN: CLARISA  TATE               PHONE NO : 925 271 0626   
131 SAND CREEK RD STE., B         SE DECISION MADE: 28-APR-14
BRENTWOOD CA 94513                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ARASYS
ION GENIUS INC                    510(k) NO: K132179(TRADITIONAL)
ATTN: XANYA  SOFRA-WEISS, PH.D    PHONE NO : 808 395 0656   
1833 KALAKAUA AVE.                SE DECISION MADE: 28-APR-14
HONOLULU HI 96801                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: OPTEO, VIDEOGRAPH HD
OWANDY                            510(k) NO: K133271(SPECIAL)
ATTN: CLAUDE  BERTHOIN            PHONE NO : 386 672 0450   
110 EAST GRANADA BLVD, SUITE 207  SE DECISION MADE: 28-APR-14
ORMOND BEACH FL 32176   32176     510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND
X6D, LTD.                         510(k) NO: K132042(TRADITIONAL)
ATTN: KAREL  VAN GORP             PHONE NO : 386 1520 5622
21 HANAFA STREET                  SE DECISION MADE: 28-APR-14
ZUR- MOSHE    IS 42810            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER
BOSTON SCIENTIFIC CORPORATION     510(k) NO: K140733(TRADITIONAL)
ATTN: MICHELLE  ROEDING           PHONE NO : 408 935 3400   
150 BAYTECH DRIVE                 SE DECISION MADE: 28-APR-14
SAN JOSE CA 95124                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CAIMAN SEAL AND CUT TECHNOLOGY
AESCULAP, INC.                    510(k) NO: K140839(SPECIAL)
ATTN: DENISE  ADAMS               PHONE NO : 610 984 9076   
3773 CORPORATE PARKWAY            SE DECISION MADE: 28-APR-14
CENTER VALLEY PA 18034            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ANATOMIC PEEK PTC CERVICAL FUSION SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K133653(TRADITIONAL)
ATTN: JULIE  BASSETT              PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 28-APR-14
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: GSP NEONATAL TOTAL GALACTOSE KIT
WALLAC OY, A SUBSIDIARY OF PERKINE510(k) NO: K133652(TRADITIONAL)
ATTN: JEANETTE  SCHIER-PUGSLEY    PHONE NO : 781 663 6025   
940 WINTER STREET                 SE DECISION MADE: 28-APR-14
WALTHAM MA 02451                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ARTIS ONE
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K133580(TRADITIONAL)
ATTN: PATRICIA D JONES            PHONE NO : 610 448 3536   
51 VALLEY STREAM PKWY.            SE DECISION MADE: 28-APR-14
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BRELLA-SPEC(TM) VAGINAL SPECULUM
PROA MEDICAL, INC.                510(k) NO: K133857(TRADITIONAL)
ATTN: VICTORIA  NADERSHAHI        PHONE NO : 310 717 5822   
2512 Artesia Blvd Ste 305C        SE DECISION MADE: 28-APR-14
Redondo Beach CA 90278            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PURACYN PLUS SKIN AND WOUND
INNOVACYN, INC.                   510(k) NO: K133542(TRADITIONAL)
ATTN: FRED L MA                   PHONE NO : 909 349 3370   
3546 N. RIVERSIDE AVE.            SE DECISION MADE: 28-APR-14
RIALTO CA 92377                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EMPRINT ABLATION SYSTEM
COVIDIEN LLC                      510(k) NO: K133821(TRADITIONAL)
ATTN: HEATHER V NIGRO             PHONE NO : 508 452 1936   
15 HAMPSHIRE ST                   SE DECISION MADE: 28-APR-14
MANSFIELD MA 02048                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SUCTION PUMP
DING HWA CO., LTD                 510(k) NO: K140031(TRADITIONAL)
ATTN: ROBERT O DEAN               PHONE NO : 716 440 7362   
1083 DELAWARE AVE.                SE DECISION MADE: 28-APR-14
BUFFALO NY 14223                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: XENMATRIX SURGICAL GRAFT
C.R. BARD                         510(k) NO: K140501(SPECIAL)
ATTN: GINA  CASSIDY               PHONE NO : 401 825 8697   
100 CROSSINGS BOULEVARD           SE DECISION MADE: 28-APR-14
WARWICK RI 02886                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NEURODYN COMPACT, NEURODYN II
IBRAMED EQUIPAMENTOS MEDICOS      510(k) NO: K131917(TRADITIONAL)
ATTN: TARA  CONRAD                PHONE NO : 305 377 0077   
18851 NE 29TH AVE 720             SE DECISION MADE: 29-APR-14
AVENTURA FL 33180                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ELECTRIC HANDPIECE SYSTEM
TTBIO CORP.                       510(k) NO: K132570(ABBREVIATED)
ATTN: SHU-CHING  LEE              PHONE NO : 886 4 23595958
2F, NO.7, 6TH ROAD INDUSTRY PARK  SE DECISION MADE: 29-APR-14
TAICHUNG, ROC    TW  40755        510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NEUROMATE FRAMELESS GEN II
RENISHAW MAYFIELD SARL            510(k) NO: K132755(TRADITIONAL)
ATTN: STEPHANE  VINOT             PHONE NO : 011 33 437238900
31, RUE AMPERE                    SE DECISION MADE: 29-APR-14
CHASSIEU    FR 69680              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NEW STETIC DENTAL AMALGAM ALLOY
NEW STETIC                        510(k) NO: K140125(TRADITIONAL)
ATTN: JOHN  O'BRIEN               PHONE NO : 813 645 2855   
445 APOLLO BEACH BLVD             SE DECISION MADE: 29-APR-14
APOLLO BEACH FL 33572             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FAMILY OF DISPOSABLE LENSES
SENSOR MEDICAL TECHNOLOGY, LLC    510(k) NO: K140368(TRADITIONAL)
ATTN: MAUREEN  O'CONNELL          PHONE NO : 978 207 1245   
5 TIMBER LANE                     SE DECISION MADE: 29-APR-14
NORTH READING MA 01864            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ACCU-CHEK AVIVA PLUS SYSTEM
ROCHE DIAGNOSTICS CORPORATION     510(k) NO: K133862(SPECIAL)
ATTN: KHONE  SAYSANA              PHONE NO : 317 521 7593   
9115 HAGUE ROAD                   SE DECISION MADE: 29-APR-14
INDIANAPOLIS IN 46250             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: GENERAL SPINAL SYSTEM
TIANJIN WALKMAN BIOMATERIAL CO., L510(k) NO: K140229(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 86 21 22815850
P.O. BOX 120-119                  SE DECISION MADE: 29-APR-14
SHANGHAI    CH 200120             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: COMFORTSOFT SOFT DENTURE LINER SYSTEM
WHIP MIX CORP.                    510(k) NO: K140146(TRADITIONAL)
ATTN: JOHN  WATERS                PHONE NO : 502 634 5357   
361 FARMINGTON AVE                SE DECISION MADE: 29-APR-14
LOUISVILLE KY 40217               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ORIGIO(R) SEQUENTIAL BLAST TM; ORIGIO(R) SEQUENTIAL BLAST TM WITH PHENOL RED
ORIGIO A/S                        510(k) NO: K133387(TRADITIONAL)
ATTN: TOVE  KJAER                 PHONE NO : 45 4679 0220
KNARDRUPVEJ 2                     SE DECISION MADE: 29-APR-14
MALOV    DA 2760                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER
CAS MEDICAL SYSTEMS, INC.         510(k) NO: K133879(TRADITIONAL)
ATTN: RON  JEFFREY                PHONE NO : 203 488 6056   
44 EAST INDUSTRIAL RD.            SE DECISION MADE: 29-APR-14
BRANFORD CT 06405                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BEAUTIFUL IMAGE FACIAL SCULPTING DEVICE
BIOSONIC TECHNOLOGIES, LLC        510(k) NO: K130065(TRADITIONAL)
ATTN: SHEPARD G BENTLEY           PHONE NO : 949 374 9187   
28241 CROWN VALLEY PARKWAY SUITE 5SE DECISION MADE: 30-APR-14
LAGUNA NIGUEL CA 92677            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MOSTDI DENTAL IMPLANT SYSTEM
MOSTDI INNOVATIONS SDN BHD        510(k) NO: K132178(TRADITIONAL)
ATTN: SUSAN  PARK                 PHONE NO : 714 525 0114   
325 N. PUENTE ST UNIT B           SE DECISION MADE: 30-APR-14
BREA CA 92821                     510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MEDTRONIC INPUT PS INTRODUCER
MEDTRONIC, INC.                   510(k) NO: K132617(TRADITIONAL)
ATTN: NISARG  SHAH                PHONE NO : 978 739 6632   
37A CHERRY HILL DRIVE             SE DECISION MADE: 30-APR-14
DANVERS MA 01923                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYSTEM
MAR COR PURIFICATION, INC.        510(k) NO: K133149(TRADITIONAL)
ATTN: KINNARI  SHAH               PHONE NO : 763 553 3369   
14605 28TH AVENUE NORTH           SE DECISION MADE: 30-APR-14
MINNEAPOLIS MN 55447              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ACUSON S1000, S2000, S3000 DIAGNOSTIC ULTRASOUND SYSTEMS
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K140959(TRADITIONAL)
ATTN: CHRISTINE  DUNN             PHONE NO : 425 785 1617   
685 EAST MIDDLEFIELD ROAD         SE DECISION MADE: 30-APR-14
MOUNTAIN VIEW CA 94043            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: FIAGON NAVIGATION SYSTEM
FIAGON GMBH                       510(k) NO: K133573(TRADITIONAL)
ATTN: DIRK  MUCHA                 PHONE NO : 49 330220 12124
NEUENDORFSTRASSE 23B              SE DECISION MADE: 30-APR-14
HENNIGSDORF    GM 16761           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SOMATOM PERSPECTIVE
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K133590(TRADITIONAL)
ATTN: KIMBERLY  MANGUM            PHONE NO : 610 448 4912   
51 VALLEY STREAM PARKWAY          SE DECISION MADE: 30-APR-14
MALVERN PA 19355 1406             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR
COEUR, INC.                       510(k) NO: K133600(TRADITIONAL)
ATTN: DEBRA F MANNING             PHONE NO : 615 547 7923   
100 PHYSICIANS WAY SUITE 200      SE DECISION MADE: 30-APR-14
LEBANON TN 37090                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CO2 MONITORING LINE, CO2 MONITORING LINE WITH FILTER
FLEXICARE                         510(k) NO: K133516(TRADITIONAL)
ATTN: CHRISTOPHER  WATKINS        PHONE NO : 441 443474 560
CYNON VALLEY BUSINESS PARK MOUNTAISE DECISION MADE: 30-APR-14
MID GLAM    UK CF454ER            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO)
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K133882(TRADITIONAL)
ATTN: ROBERT  CASARSA             PHONE NO : 414 362 3063   
8200 WEST TOWER AVE.              SE DECISION MADE: 30-APR-14
Milwaukee WI 53223                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ENCORE 26 ADVANTAGE KIT
BOSTON SCIENTIFIC CORP.           510(k) NO: K140745(SPECIAL)
ATTN: LISA  MEE                   PHONE NO : 
ONE SCIMED PLACE                  SE DECISION MADE: 17-APR-14
MAPLE GROVE MN 55311 1566         510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SPLIT CATH RG
MEDCOMP                           510(k) NO: K130889(TRADITIONAL)
ATTN: TIMOTHY  HOLWICK            PHONE NO : 215 256 4201   
1499 DELP DR.                     SE DECISION MADE: 28-APR-14
HARLEYSVILLE PA 19438             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DA VINCI SP SURGICAL SYSTEM, ENDOWRIST SP INSTRUMENTS, AND ACCESSORIES
INTUITIVE SURGICAL, INC.          510(k) NO: K131962(TRADITIONAL)
ATTN: MIKE  YRAMATEGUI            PHONE NO : 408 523 2100   
1266 KIFER ROAD                   SE DECISION MADE: 17-APR-14
SUNNYVALE CA 94086                510(k) SUMMARY AVAILABLE FROM FDA
 
 
                                                 TOTAL 510(k)s THIS PERIOD   270                                     
                                                 TOTAL WITH SUMMARIES        251                                     
                                                 TOTAL WITH STATEMENTS        19
                                      

 

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