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Home » FDA releases September 2013 510(k) approvals

FDA releases September 2013 510(k) approvals

October 15, 2013 By Arezu Sarvestani

FDA logo

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

TOTAL 510(k)s THIS PERIOD 214
TOTAL WITH SUMMARIES 195
TOTAL WITH STATEMENTS 19

DEVICE: PROSIGNA BREAST CANCER PROGNOSIS GENE SIGNATURE ASSAY
NANOSTRING TECHNOLOGIES           510(k) NO: K130010(TRADITIONAL)
ATTN: SYLVA  KRIZAN, PHD          PHONE NO : 206 378 6266  
530 Fairview Ave N Ste 2000       SE DECISION MADE: 06-SEP-13
Seattle WA 98109                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)
VENTANA MEDICAL SYSTEMS, INC.     510(k) NO: K121033(TRADITIONAL)
ATTN: ERIKA  AMMIRATI             PHONE NO : 650 949 2768  
575 SHIRLYNN COURT                SE DECISION MADE: 06-SEP-13
LOS ALTOS CA 94022                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIAISON XL HCG
DIASORIN, INC.                    510(k) NO: K131037(TRADITIONAL)
ATTN: MARI  MEYER                 PHONE NO : 651 351 5635  
1951 NORTHWESTERN AVE. P.O. BOX 28SE DECISION MADE: 06-SEP-13
STILLWATER MN 55082 0285          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUIDEL MOLECULAR RSV + HMPV ASSAY
QUIDEL CORP.                      510(k) NO: K131813(TRADITIONAL)
ATTN: RONALD H LOLLAR             PHONE NO : 858 552 1100  
10165 MCKELLAR CT.                SE DECISION MADE: 06-SEP-13
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XTAG CYP2C19 KIT V3
LUMINEX MOLECULAR DIAGNOSTICS, INC510(k) NO: K131565(TRADITIONAL)
ATTN: RONALD  DUNN                PHONE NO : 608 203895 0
439 UNIVERSITY AVE.               SE DECISION MADE: 11-SEP-13
TORONTO, ONTARIO    CA M5G 1Y8    510(k) STATEMENT

DEVICE: VYSIS D7S486/CEP 7 FISH PROBE KIT
ABBOTT MOLECULAR, INC.            510(k) NO: K131508(TRADITIONAL)
ATTN: NANCY W BENGTSON            PHONE NO : 224 361 7087  
1300 EAST TOUHY AVENUE            SE DECISION MADE: 13-SEP-13
DES PLAINES IL 60018              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITEK 2 AST ST MOXIFLOXACIN, VITEK 2 AST STREPTOCOCCUS MOXIFLOXACIN
BIOMERIEUX, INC.                  510(k) NO: K132573(TRADITIONAL)
ATTN: NATHAN  HARDESTY            PHONE NO : 314 731 8666  
595 ANGLUM RD.                    SE DECISION MADE: 13-SEP-13
HAZELWOOD MO 63042                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER
VENTANA MEDICAL SYSTEMS, INC.     510(k) NO: K122143(TRADITIONAL)
ATTN: ERIKA B AMMIRATI            PHONE NO : 650 949 2768  
575 SHIRLYNN COURT                SE DECISION MADE: 19-SEP-13
LOS ALTOS CA 94022                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI
BIO-RAD LABORATORIES, INC.        510(k) NO: K130053(TRADITIONAL)
ATTN: JUANG  WANG                 PHONE NO : 510 741 4609  
5500 EAST 2ND ST.                 SE DECISION MADE: 19-SEP-13
BENICIA CA 94510                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PHILIPS HERCEPTEST DIGITAL SCORE
PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K130021(TRADITIONAL)
ATTN: DIRK  VOSSEN                PHONE NO : 316 511 81374
VEENPLUIS 4-6                     SE DECISION MADE: 19-SEP-13
BEST, NB    NL 5684 PC            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
CENTERS FOR DISEASE CONTROL AND PR510(k) NO: K132508(TRADITIONAL)
ATTN: HYE-JOO  KIM, PHARM.D.      PHONE NO : 404 639 4643  
1600 CLIFTON RD., N.E. MAILSTOP C-SE DECISION MADE: 23-SEP-13
ATLANTA GA 30333                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIRTUOSO SYSTEM FOR IHC HER2 (4B5)
VENTANA MEDICAL SYSTEMS, INC.     510(k) NO: K121516(TRADITIONAL)
ATTN: ERIKA  AMMIRATI             PHONE NO : 650 949 2768  
575 SHIRLYNN COURT                SE DECISION MADE: 26-SEP-13
LOS ALTOS CA 94022                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TEST
TIANJIN NEW BAY BIORESEARCH CO., L510(k) NO: K130275(TRADITIONAL)
ATTN: ROGER  DE BOCK              PHONE NO : 619 453 0930  
4455 MURPHY CANYON RD SUITE 204   SE DECISION MADE: 26-SEP-13
SAN DIEGO CA 92123                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE  URINE TEST  (MET 300)
GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K132630(TRADITIONAL)
ATTN: JOE  SHIA                   PHONE NO : 240 505 7880  
504 EAST DIAMOND AVE. SUITE F     SE DECISION MADE: 27-SEP-13
GAITHERSBURG MD 20878             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VARILIFT-L INTERBODY FUSION DEVICE
WENZEL SPINE, INC.                510(k) NO: K131296(TRADITIONAL)
ATTN: SANDIE  ROTH                PHONE NO : 512 501 4022  
206 WILD BASIN RD, BLDG A, STE 203SE DECISION MADE: 03-SEP-13
AUSTIN TX 78746                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARDIS INTERBODY SYSTEM
ZIMMER SPINE, INC                 510(k) NO: K131242(TRADITIONAL)
ATTN: JON  GILBERT                PHONE NO : 952 830 6385  
SE DECISION MADE: 03-SEP-13
MINNEAPOLIS MN 55441              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS,
BIOMET MANUFACTURING CORP.        510(k) NO: K123907(TRADITIONAL)
ATTN: ELIZABETH  WRAY             PHONE NO : 574 371 1176  
56 EAST BELL DRIVE P.O. BOX 587   SE DECISION MADE: 03-SEP-13
WARSAW IN 46581 0587              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RESURFX 1565NM LASER MODULE
LUMENIS, LTD.                     510(k) NO: K130028(TRADITIONAL)
ATTN: YORAM  LEVY                 PHONE NO : 972 4638 8837
31 HAAVODA ST.                    SE DECISION MADE: 03-SEP-13
BINYAMINA    IS 30500             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: U-MOTION II PS+ CUP
UNITED ORTHOPEDIC CORP.           510(k) NO: K132455(SPECIAL)
ATTN: FANG-YUAN  HO               PHONE NO : 886 357 73351X2217
NO 57, PARK AVE. 2, SCIENCE PARK  SE DECISION MADE: 03-SEP-13
HSINCHU    TW 300                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTERFUSE L INTERVERTEBRAL BODY FUSION DEVICE
VERTEBRAL TECHNOLOGIES, INC.      510(k) NO: K131540(TRADITIONAL)
ATTN: SURESH  GHAI                PHONE NO : 952 979 9357  
5909 BAKER ROAD SUITE 550         SE DECISION MADE: 03-SEP-13
MINNETONKA MN 55345               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
ACCEL SPINE                       510(k) NO: K132366(SPECIAL)
ATTN: AEKTA  PATEL                PHONE NO : 214 545 5833  
14901 QUORUM DR. STE. 125         SE DECISION MADE: 03-SEP-13
DALLAS TX 75254                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH
ACCESS SCIENTIFIC, LLC            510(k) NO: K131148(TRADITIONAL)
ATTN: ALBERT  MISAJON             PHONE NO : 858 259 8333  
3910 Sorrento Valley Blvd Ste 200 SE DECISION MADE: 04-SEP-13
San Diego CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION
DIACOUSTIC MEDICAL DEVICES (PTY) L510(k) NO: K131044(TRADITIONAL)
ATTN: YOLANDA  SMITH              PHONE NO : 888 729 9674  
1468 HARWELL AVENUE               SE DECISION MADE: 04-SEP-13
CROFTON MD 21114                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOSPACE
BIOSPACE CORPORATION LIMITED      510(k) NO: K131064(TRADITIONAL)
ATTN: DANIEL  KAMM                PHONE NO : 239 234 1735  
8870 RAVELLO CT                   SE DECISION MADE: 04-SEP-13
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTEGRA INTERSPINOUS PROCESS SYSTEM
SEASPINE, INC.                    510(k) NO: K121924(TRADITIONAL)
ATTN: NICK M CORDARO              PHONE NO : 760 216 5603  
2302 la Mirada Dr                 SE DECISION MADE: 04-SEP-13
VISTA CA 92081                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POLARIS SPINAL SYSTEM
BIOMET SPINE (AKA EBI, LLC)       510(k) NO: K131615(TRADITIONAL)
ATTN: VIVIAN  KELLY               PHONE NO : 973 299 9300  
399 JEFFERSON ROAD                SE DECISION MADE: 04-SEP-13
PARSIPPANY NJ 07054               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS
GE HUNGARY KFT                    510(k) NO: K132045(TRADITIONAL)
ATTN: STEPHEN  SLAVENS            PHONE NO : 262 548 4992  
3000 N GRANDVIEW DIVISION: DBA GE SE DECISION MADE: 04-SEP-13
WAUKESHA WI 53188                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM
ZIMMER SPINE, INC.                510(k) NO: K131980(TRADITIONAL)
ATTN: JONATHAN  GILBERT           PHONE NO : 952 830 6385  
7375 BUSH LAKE RD.                SE DECISION MADE: 04-SEP-13
MINNEAPOLIS MN 55439              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 5MP GRAYSCALE LCD DISPLAY
SHENZHEN BEACON DISPLAY TECHNOLOGY510(k) NO: K132610(TRADITIONAL)
ATTN: WU  QIN                     PHONE NO : 86 755 26995355
RM 201, INCUBATOR BUILDING, CASTD,SE DECISION MADE: 04-SEP-13
SHENZHEN    CH 518057             510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW

DEVICE: KOSTEC MEDICAL GRADE LDC MONITORS
KOSTEC  CO., LTD                  510(k) NO: K123944(TRADITIONAL)
ATTN: RHONDA  ALEXANDER, MS, MPA  PHONE NO : 757 224 0177  
144 RESEARCH DRIVE MEDICAL DEVICE SE DECISION MADE: 05-SEP-13
HAMPTON VA 23666                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STITCHKIT
ORIGAMI SURGICAL LLC              510(k) NO: K123811(TRADITIONAL)
ATTN: JOHN  GILLESPIE             PHONE NO : 774 567 0277  
79 HAVEN ST.                      SE DECISION MADE: 05-SEP-13
DOVER MA 02030                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM
SYNTHES                           510(k) NO: K123723(TRADITIONAL)
ATTN: ALAN T HALEY                PHONE NO : 484 356 9763  
1301 GOSHEN PARKWAY               SE DECISION MADE: 05-SEP-13
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARIX FOOT SYSTEM
JEIL MEDICAL CORPORATION          510(k) NO: K131311(TRADITIONAL)
ATTN: JI-EUN  KIM                 PHONE NO : 82 2 8503500
#702, KOLON SCIENCE VALLEY 2ND 811SE DECISION MADE: 05-SEP-13
SEOUL-CITY    KS 152-050          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACUMED WRIST SPANNING PLATE
ACUMED LLC                        510(k) NO: K131764(TRADITIONAL)
ATTN: NATHAN  WOLF                PHONE NO : 503 207 1502  
5885 NW Cornelius Pass Rd         SE DECISION MADE: 05-SEP-13
HILLSBORO OR 97124                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300
ST. JUDE MEDICAL SYSTEMS AB       510(k) NO: K131452(TRADITIONAL)
ATTN: ERDULFO  DE PERALTA         PHONE NO : 978 577 3481  
4 ROBBINS RD.                     SE DECISION MADE: 05-SEP-13
WESTFORD MA 01886                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Z5MLB, Z5MLC
Z-SYSTEMS AG                      510(k) NO: K131701(TRADITIONAL)
ATTN: LINDA K SCHULZ              PHONE NO : 858 792 1235  
12264 EL CAMINO REAL STE. 400     SE DECISION MADE: 05-SEP-13
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TEPHAFLEX BRAIDED SUTURE
TEPHA, INC.                       510(k) NO: K132348(TRADITIONAL)
ATTN: MARY P LEGRAW               PHONE NO : 781 357 1709  
99 HAYDEN, SUTIE 360              SE DECISION MADE: 05-SEP-13
LEXINGTON MA 02421                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIAISON 25 TOTAL-D
DIASORIN, INC.                    510(k) NO: K132492(TRADITIONAL)
ATTN: MARI  MEYER                 PHONE NO : 651 351 5635  
1951 NORTHWESTERN AVE. P.O. BOX 28SE DECISION MADE: 05-SEP-13
STILLWATER MN 55082 0285          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET
TELEFLEX MEDICAL, INC.            510(k) NO: K122235(SPECIAL)
ATTN: LORI  PFOHL                 PHONE NO : 919 433 4908  
2917 WECK DR.                     SE DECISION MADE: 06-SEP-13
RESEARCH TRIANGLE PARK NC 27709   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FREEMIE BREAST COLLECTION SYSTEM
DAO HEALTH                        510(k) NO: K130349(TRADITIONAL)
ATTN: DAN  GARBEZ                 PHONE NO : 916 339 7388  
1345 EASY LN. EL DORADO HILLS     SE DECISION MADE: 06-SEP-13
CALIFORNIA CA 95762               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JUSHA-C31 MEDICAL DISPLAY
NANJING JUSHA DISPLAY TECHNOLOGY C510(k) NO: K131389(TRADITIONAL)
ATTN: MIKE  GU                    PHONE NO : 86 20 62321333
7TH FLOOR, 982. CONGYUN RD. BAIYUNSE DECISION MADE: 06-SEP-13
GUANGZHOU, GUANGDONG    CH 510420 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XPERCT REL. 3
PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K130893(ABBREVIATED)
ATTN: LISELOTTE  KORNMANN         PHONE NO : 31 611621 238
VEENPLUIS 4-6                     SE DECISION MADE: 06-SEP-13
BEST    NL 5684 PC                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PEAK Z
ULTRADENT PRODUCTS, INC.          510(k) NO: K131357(TRADITIONAL)
ATTN: DIANE  ROGERS               PHONE NO : 801 553 4491  
505 WEST 10200 SOUTH              SE DECISION MADE: 06-SEP-13
SOUTH JORDAN UT 84095             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES
WORLDMED MANUFACTURING SDN. BHD.  510(k) NO: K121844(TRADITIONAL)
ATTN: CHANDRASEGARAN              PHONE NO : 605 829 5555
LOT 18873, JALAN PERUSAHAAN 3, KAMSE DECISION MADE: 06-SEP-13
KAMUNTING    MY 34600             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALIVECOR HEART MONITOR
ALIVECOR, INC.                    510(k) NO: K130409(TRADITIONAL)
ATTN: MICHAEL  RIGHTER            PHONE NO : 415 795 9812  
30 MAIDEN LANE, 6TH FLOOR         SE DECISION MADE: 06-SEP-13
SAN FRANCISCO CA 94108            510(k) STATEMENT

DEVICE: STRAWBERRY, STRAWBERRY & CREAM
LASER LIPO LIMITED                510(k) NO: K130341(TRADITIONAL)
ATTN: IAN  COBLEY                 PHONE NO : 011 44 8449801820
HEATH HOUSE, CROCKHAM HILL        SE DECISION MADE: 06-SEP-13
EDENBRIDGE, KENT    UK TN8 6ST    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GORE SEAMGUARD REINFORCEMENT
W. L. GORE & ASSOCIATES, INC.     510(k) NO: K131658(TRADITIONAL)
ATTN: BARBARA L SMITH             PHONE NO : 410 506 8189  
301 AIRPORT RD.                   SE DECISION MADE: 06-SEP-13
ELKTON MD 21921                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE 2 ANTERIOR CERVICAL PLATE SYST
MEDOS INTERNATIONAL SARL          510(k) NO: K132324(SPECIAL)
ATTN: KIRSTEN  LEHMULLER          PHONE NO : 508 828 3291  
325 PARAMOUNT DRIVE               SE DECISION MADE: 06-SEP-13
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: K-PACK II NEEDLE – 27G X 3/4" THIN WALL
TERUMO EUROPE N.V.                510(k) NO: K132233(SPECIAL)
ATTN: M.J.  AERTS                 PHONE NO : 320 163812 11
INTERLEUVENLAAN 40                SE DECISION MADE: 06-SEP-13
LEUVEN    BE 3001                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COMPREHENSIVE REVERSE SHOULDER SCREWS
BIOMET MANUFACTURING CORP.        510(k) NO: K132239(TRADITIONAL)
ATTN: PATRICIA S BERES            PHONE NO : 574 267 6639  
56 BELL DRIVE                     SE DECISION MADE: 06-SEP-13
WARSAW IN 46580                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FIRECR DENTALIMAGING SYSTEM
3DISC AMERICAS                    510(k) NO: K131442(TRADITIONAL)
ATTN: DANIEL  KAMM                PHONE NO : 239 234 1735   
8870 RAVELLO CT                   SE DECISION MADE: 06-SEP-13
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EYESEECAM VHIT
INTERACOUSTICS A/S                510(k) NO: K131681(TRADITIONAL)
ATTN: ERIK  NIELSEN               PHONE NO : 45 637 13555
DREJERVAENGET 8                   SE DECISION MADE: 06-SEP-13
ASSENS    DA DK-5610              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THERMAGE CPT SYSTEM
SOLTA MEDICAL, INC.               510(k) NO: K132431(SPECIAL)
ATTN: RAYMOND  LEE                PHONE NO : 510 259 7159  
25881 INDUSTRIAL BLVD.            SE DECISION MADE: 06-SEP-13
HAYWARD CA 94545                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SINGLE USE GROUNDING PAD
LCCS PRODUCTS LIMITED             510(k) NO: K132136(TRADITIONAL)
ATTN:                             PHONE NO :
7TH FL, JINGGUI BUSINESS BLDG, NO.SE DECISION MADE: 06-SEP-13
GUANGZHOU, GUANGDONG    CH 510420 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FRESENIUS LIBERTY CYCLER
FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K123630(TRADITIONAL)
ATTN: DENISE  OPPERMANN           PHONE NO : 781 699 4479  
920 WINTER ST                     SE DECISION MADE: 09-SEP-13
WALTHAM MA 02451                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RESPIRE PINK SERIES – HERBST
RESPIRE MEDICAL                   510(k) NO: K131138(TRADITIONAL)
ATTN: DANIELA  LEVY               PHONE NO : 213 787 3026  
22817 VENTURA BLVD #161           SE DECISION MADE: 09-SEP-13
WOODLAND HILLS CA 91364           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTION
BAUSCH & LOMB INCORPORATED        510(k) NO: K132216(SPECIAL)
ATTN: SAMANTHA  DUFFY             PHONE NO : 585 338 8187  
1400 NORTH GOODMAN ST.            SE DECISION MADE: 09-SEP-13
ROCHESTER NY 14609                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOSIGN FLU A + B, STATUS FLU A & B
PRINCETON BIOMEDITECH CORP.       510(k) NO: K132465(SPECIAL)
ATTN: KYUNG-AH  KIM, PH.D.        PHONE NO : 732 274 1000  
4242 U.S. RT. 1                   SE DECISION MADE: 09-SEP-13
MONMOUTH JUNCTION NJ 08852 1905   510(k) STATEMENT

DEVICE: POWER FREE VINYL EXAMINATION GLOVES
WANG TONG XINGHUA CO., LTD        510(k) NO: K122102(TRADITIONAL)
ATTN: GUO  YANG                   PHONE NO : 865 238 3495629
WEST OF GUO JING ROAD ECONOMIC DEVSE DECISION MADE: 09-SEP-13
XINGHUA    CH 225700              510(k) STATEMENT

DEVICE: EP-WORKMATE, EP-NURSEMATE, EP-NURSEMATE WITH PHYSIO MODULE
ST. JUDE MEDICAL                  510(k) NO: K132073(SPECIAL)
ATTN: KRIS  MILLER                PHONE NO : 651 756 2954  
ONE ST. JUDE MEDICAL DRIVE        SE DECISION MADE: 09-SEP-13
ST. PAUL MN 55117                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APEX UNIVERSAL ADHESIVE
APEX DENTAL MATERIALS, INC.       510(k) NO: K131043(TRADITIONAL)
ATTN: CHRIS  KULTON               PHONE NO : 847 719 1133  
330 TELSER ROAD                   SE DECISION MADE: 10-SEP-13
LAKE ZURICH IL 60047              510(k) STATEMENT

DEVICE: CCS-200 SPIROMETER
BENSON MEDICAL INSTRUMENTS CO.    510(k) NO: K123896(TRADITIONAL)
ATTN: DAVID  MAYOU                PHONE NO : 612 827 2222  
310FOURTH AVE SOUTH SUITE 5000    SE DECISION MADE: 10-SEP-13
MINNEAPOLIS MN 55415              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST
CHURCH & DWIGHT CO., INC.         510(k) NO: K123567(TRADITIONAL)
ATTN: LISA  BURNS                 PHONE NO : 609 497 7482  
469 NORTH HARRISON STREET         SE DECISION MADE: 10-SEP-13
PRINCETON NJ 08543                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TIGER SPINE SYSTEM
CORELINK LLC                      510(k) NO: K131250(TRADITIONAL)
ATTN: MEREDITH  MAY               PHONE NO : 719 337 7579  
4628 NORTHPARK DRIVE              SE DECISION MADE: 10-SEP-13
COLORADO SPRINGS CO 80918         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RETROGRADE FEMORAL NAIL
ADVANCED ORTHOPAEDIC SOLUTIONS, IN510(k) NO: K132005(TRADITIONAL)
ATTN: ALLYSON  PARKS              PHONE NO : 310 533 9966  
386 Beech Ave. Unit B6            SE DECISION MADE: 10-SEP-13
TORRANCE CA 90501                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA,
BAUSCH & LOMB, INC.               510(k) NO: K131208(TRADITIONAL)
ATTN: BARBARA  KLUBE-FALSO        PHONE NO : 585 338 8503   
1400 NORTH GOODMAN ST.            SE DECISION MADE: 11-SEP-13
ROCHESTER NY 14609 3547           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IHEALTH FINGERTIP PULSE OXIMETER
ANDON HEALTH CO.,LTD              510(k) NO: K131111(TRADITIONAL)
ATTN: LIU  YU                     PHONE NO : 86 22 60526161
#3,  JIN PING STREET YA AN RD NANKSE DECISION MADE: 11-SEP-13
TIANJIN    CH 300190              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SHOFU BLOCK HC
SHOFU DENTAL CORPORATION          510(k) NO: K130841(TRADITIONAL)
ATTN: DAVID P MORAIS              PHONE NO : 760 736 3277  
1225 STONE DRIVE                  SE DECISION MADE: 11-SEP-13
SAN MARCOS CA 92078               510(k) STATEMENT

DEVICE: PULSE OXIMETER
NONIN MEDICAL, INC.               510(k) NO: K131021(TRADITIONAL)
ATTN: BRODIE  PEDERSEN            PHONE NO : 763 577 3180  
13700 1ST AVE. NORTH              SE DECISION MADE: 11-SEP-13
PLYMOUTH MN 55441 5443            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KITAZATO IUI CATHETER
KITAZATO MEDICAL CO., LTD.        510(k) NO: K131491(TRADITIONAL)
ATTN: RICHARD  VINCINS, CBA, CQA, PHONE NO : 512 327 9997  
816 CONGRESS AVE. STE. 1400       SE DECISION MADE: 11-SEP-13
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURGICAL GOWN (EO STERILIZED)
COBES INDUSTRIES CO., LTD.        510(k) NO: K112796(TRADITIONAL)
ATTN: LEON  LU                    PHONE NO : 877 202 1588  
3500 SOUTH DUPONT HIGHWAY         SE DECISION MADE: 12-SEP-13
DOVER DE 19901                    510(k) STATEMENT

DEVICE: AUTOMATIC BLOOD PRESSURE MONITOR
HONSUN (NANTONG) CO., LTD.        510(k) NO: K130925(TRADITIONAL)
ATTN: SELINA  QIAN                PHONE NO : 86 0513 80580022
NO.8, Tongxing Road, Nantong EconoSE DECISION MADE: 12-SEP-13
NANTONG, JIANGSU    CH 226009     510(k) STATEMENT

DEVICE: JUNG RIM SINGLE USE HYPODERMIC SYRINGE WITH NEEDLE
JUNG RIM MEDICAL INDUSTRIAL CO., L510(k) NO: K124037(TRADITIONAL)
ATTN: KYU  LEE                    PHONE NO : 82 2 4047986
#593-81, SAGOK-RI, LWOL-MYEON     SE DECISION MADE: 12-SEP-13
JINCHEON-GUN, CHUNGBUK    KN 365-8510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S
AUDIFON-USA INC.                  510(k) NO: K130417(ABBREVIATED)
ATTN: JANE E PERRONE              PHONE NO : 386 668 8812  
403 CHAIRMAN CT., STE. 1          SE DECISION MADE: 12-SEP-13
DEBARY FL 32713                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IPROPHY MOBILE
NAKANISHI, INC.                   510(k) NO: K131578(TRADITIONAL)
ATTN: DIANE  RUTHERFORD           PHONE NO : 972 480 9554  
1201 RICHARDSON DRIVE SUITE 280   SE DECISION MADE: 12-SEP-13
RICHARDSON TX 75080               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UNIVERSAL PASTE STAINS AND GLAZE
PRISMATIK DENTALCRAFT, INC.       510(k) NO: K130604(TRADITIONAL)
ATTN: ARMIN  ZEHTABCHI            PHONE NO : 949 225 1234  
2212 DUPONT DR., SUITE JJK        SE DECISION MADE: 12-SEP-13
IRVINE CA 92612                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIVORTE BVF
VIVORTE, INC                      510(k) NO: K130703(TRADITIONAL)
ATTN: STEPHEN J PEOPLES           PHONE NO : 260 645 0327  
5010 LODGE PLE LANE               SE DECISION MADE: 12-SEP-13
FORT WAYNE IN 46814               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QXLINK
VIEWORKS CO., LTD.                510(k) NO: K132302(TRADITIONAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 202 5789  
1515 E. KATELLA AVENUE UNIT 2115  SE DECISION MADE: 12-SEP-13
ANAHEIM CA 92805                  510(k) STATEMENT

DEVICE: EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM
DEPUY SPINE, A JOHNSON & JOHNSON C510(k) NO: K131802(SPECIAL)
ATTN: KIRSTEN  LEHMULLER          PHONE NO : 508 828 3291  
325 PARAMOUNT DRIVE               SE DECISION MADE: 12-SEP-13
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTISTIM
METRON MEDICAL AUSTRALIA PTY LTD  510(k) NO: K132137(SPECIAL)
ATTN: DAVID  MITCHELL             PHONE NO : 613 977 51234
57 ASTER AVE.                     SE DECISION MADE: 12-SEP-13
CARRUM DOWNS, VICTORIA    AS 3201 510(k) STATEMENT

DEVICE: ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI
CEREMED, INC.                     510(k) NO: K132198(TRADITIONAL)
ATTN: CHELSEA  MITCHELL           PHONE NO : 310 815 2125  
3643 LENAWEE AVE.                 SE DECISION MADE: 12-SEP-13
LOS ANGELES CA 90016              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCULIF TL AND PL CAGE
COALIGN INNOVATIONS, INC.         510(k) NO: K132505(SPECIAL)
ATTN:                             PHONE NO :
1331 H STREET NW 12TH FLOOR       SE DECISION MADE: 12-SEP-13
WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAS PSI KNEE SYSTEM
ORTHOSOFT, INC.                   510(k) NO: K131409(TRADITIONAL)
ATTN: CHRISTOPHER  MCLEAN         PHONE NO : 514 861 4074  
75 QUEEN ST., SUITE 3300          SE DECISION MADE: 13-SEP-13
MONTREAL, QUEBEC    CA H3C 2N6    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DA VINCI FLUORESCENCE IMAGING VISION SYSTEM
INTUITIVE SURGICAL, INC.          510(k) NO: K124031(TRADITIONAL)
ATTN: CINDY  DOMECUS              PHONE NO : 650 343 4813  
1266 KIFER ROAD BUILDING 101      SE DECISION MADE: 13-SEP-13
SUNNYVALE CA 94086 5206           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PIONEER ELITE DIODE LASER
CAO GROUP, INC.                   510(k) NO: K131059(TRADITIONAL)
ATTN: ROBERT K LARSEN             PHONE NO : 801 256 9282  
4628 WEST SKYHAWK DRIVE           SE DECISION MADE: 13-SEP-13
WEST JORDAN UT 84084              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER
EDWARDS LIFESCIENCES, LLC.        510(k) NO: K132175(TRADITIONAL)
ATTN: LUKE  MEIDELL               PHONE NO : 801 565 6212  
12050 LONE PEAK PKWY              SE DECISION MADE: 13-SEP-13
DRAPER UT 84020                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LOGIC STAND-ALONE INTERVERTEBRAL BODY FUSION DEVICE
BINDER BIOMEDICAL, INC            510(k) NO: K130641(TRADITIONAL)
ATTN: LAWRENCE  BINDER            PHONE NO : 561 981 2682  
1951 NW 7TH AVENUE, STE 13135     SE DECISION MADE: 13-SEP-13
MIAMI FL 33136                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)
OKTX LLC                          510(k) NO: K123902(TRADITIONAL)
ATTN: MARY ROSE C REASTON         PHONE NO : 702 234 1014  
7225 S 85TH E AVE. SUITE 300      SE DECISION MADE: 13-SEP-13
TULSA OK 74137                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LOBSTER AUTO-INJECTOR
SCANDINAVIAN HEALTH LIMITED       510(k) NO: K124026(TRADITIONAL)
ATTN: JAMES  HAYNES               PHONE NO : 954 725 2046  
#588 JIM MORAN BLVD               SE DECISION MADE: 13-SEP-13
DEERFIELD BEACH FL 33442          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SASMAR ORIGINAL, SASMAR CLASSIC
SASMAR INC                        510(k) NO: K131084(TRADITIONAL)
ATTN: JOHN-MICHAEL  MANCINI       PHONE NO : 773 942 0030  
155 NORTH WACKER DR, STE 4250     SE DECISION MADE: 13-SEP-13
CHICAGO IL 60606                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 6MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 8MM X 07M
VITAL ACCESS                      510(k) NO: K130873(TRADITIONAL)
ATTN: CHRISTOPHER  PHILLIPS       PHONE NO : 801 433 9390  
2302 S.PRESIDENTS DR SUITE C      SE DECISION MADE: 13-SEP-13
SALT LAKE CITY UT 84120           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TANYX
MEDECELL US, INC                  510(k) NO: K123866(TRADITIONAL)
ATTN: RHONDA  ALEXANDER, M.S., M.PPHONE NO : 757 224 0177  
144 RESEARCH DRIVE                SE DECISION MADE: 13-SEP-13
HAMPTON VA 23666                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTERLOCK – 18 FIBERED IDC OCCLUSION SYSTEM
BOSTON SCIENTIFIC CORP.           510(k) NO: K132578(SPECIAL)
ATTN: TODD  KORNMANN              PHONE NO : 763 494 1348  
ONE SCIMED PLACE                  SE DECISION MADE: 13-SEP-13
MAPLE GROVE MN 55311              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CEROX
OR-NIM MEDICAL LTD.               510(k) NO: K131854(SPECIAL)
ATTN: MICHA  OESTEREICH           PHONE NO : 972 892 82801
15 ATIR YEDA ST.                  SE DECISION MADE: 13-SEP-13
KFAR SABA    IS 4464312           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADVIA CENTAUR FT4, ADVIA CENTAUR T4
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K132249(TRADITIONAL)
ATTN: MATTEW  GEE                 PHONE NO : 914 524 2099  
511 BENEDICT AVE.                 SE DECISION MADE: 13-SEP-13
TARRYTOWN NY 10591                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELECTROSURGICAL GENERATOR
BEIJING JINHENGWEI TECHNOLOGY DEVE510(k) NO: K130760(TRADITIONAL)
ATTN: LIGANG  MAO                 PHONE NO : 86 10 67916414
NO. 631 XINGONG VILLAGE EAST SIDE SE DECISION MADE: 16-SEP-13
BEIJING    CH 100069              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PNEUPAC PARAPAC PLUS
SMITHS MEDICAL INTERNATIONAL LTD. 510(k) NO: K123957(TRADITIONAL)
ATTN: LORI  BERENDS               PHONE NO :
BRAMINGHAM BUSINESS PARK ENTERPRISSE DECISION MADE: 16-SEP-13
LUTON, BEDFORDSHIRE    UK LU3 4BU 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DEPUY CORAIL AMT HIP PROSTHESIS
DEPUY FRANCE S.A.S.               510(k) NO: K123991(TRADITIONAL)
ATTN: ALMA  RELJA, RAC            PHONE NO : 574 372 7349  
700 ORTHOPAEDIC DRIVE             SE DECISION MADE: 16-SEP-13
WARSAW IN 46581                   510(k) STATEMENT

DEVICE: NOVOKNEE TOTAL KNEE SYSTEM
NOVOSOURCE INC                    510(k) NO: K131398(TRADITIONAL)
ATTN: JAMES  PINKSTON             PHONE NO : 435 774 1502  
560 W. GOLF COURSE RD CO-INNOVATIOSE DECISION MADE: 16-SEP-13
PROVIDENCE UT 84332               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)
SHENZHEN DONGDIXIN TECHNOLOGY CO, 510(k) NO: K130802(TRADITIONAL)
ATTN: JIANPING  KANG              PHONE NO : 86 755276 52471
XILIXIAOBAIMANG                   SE DECISION MADE: 16-SEP-13
SHENZHEN, GUANGDONG    CH 518108  510(k) STATEMENT

DEVICE: RAMPART-O, RAMPART-T
SPINEOLOGY, INC.                  510(k) NO: K132053(TRADITIONAL)
ATTN: BRYAN  BECKER               PHONE NO : 651 256 8534  
7800 3RD ST N., SUITE 600         SE DECISION MADE: 16-SEP-13
ST. PAUL MN 55128                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEART SYNC
HEART SYNC INC.                   510(k) NO: K131494(TRADITIONAL)
ATTN: DANIEL  KAMM                PHONE NO : 239 234 1735  
8870 RAVELLO CT                   SE DECISION MADE: 16-SEP-13
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BLOM-SINGER SEPTAL PERFORATION PROSTHESIS
HELIX MEDICAL, LLC                510(k) NO: K131745(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155  
1110 MARK AVE.                    SE DECISION MADE: 17-SEP-13
CARPINTERIA CA 93013              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CREODENT SOLIDEX CUSTOM ABUTMENT
CREODENT PROSTHETICS LTD.         510(k) NO: K113738(TRADITIONAL)
ATTN: CALVIN  SHIM                PHONE NO : 212 302 3860  
29TH WEST STREET 11TH FLOOR       SE DECISION MADE: 17-SEP-13
NEW YORK NY 10001                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FACIAL SPA
NUSKIN                            510(k) NO: K122711(TRADITIONAL)
ATTN: PAUL  RUBIN                 PHONE NO : 202 508 4709  
ONE METRO CENTER 700 12TH STREET, SE DECISION MADE: 17-SEP-13
WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL FLAT PANEL X-RAY DETECTOR
RAYENCE CO., LTD                  510(k) NO: K131114(TRADITIONAL)
ATTN: DAVE  KIM                   PHONE NO : 713 467 2607  
12946 KIMBERLEY LN                SE DECISION MADE: 17-SEP-13
HOUSTON TX 77079                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MICRO-TOUCH LP, MULIT-PURPOSE WORKSTATION,
CIVCO MEDICAL INSTRUMENTS CO., INC510(k) NO: K131161(TRADITIONAL)
ATTN: AMANDA  STAHLE              PHONE NO : 319 248 6628  
102 FIRST ST. SOUTH               SE DECISION MADE: 17-SEP-13
Kalona IA 52247                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELECTRONIC BLOOD PRESSURE MONITOR FOR UPPER ARM
JINXINBAO ELECTRONIC CO.,LTD      510(k) NO: K130232(ABBREVIATED)
ATTN: HELEN  NAN                  PHONE NO : 086 577886 06182
ROOM 404, BLDG 7, JINHUICHANG HOMESE DECISION MADE: 17-SEP-13
WENZHOU, ZHEJIANG    CH 325000    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANSWATCH WRIST MONITOR MODEL TS-0411
TAIWAN SCIENTIFIC CORPORATION     510(k) NO: K123130(TRADITIONAL)
ATTN: DEHCHUAN  SUN               PHONE NO : 886 2 86673362
10F, 88-4, MING-CHIUAN RD, SHIN-DISE DECISION MADE: 17-SEP-13
NEW TAIPEI    TW 23141            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL AND STAINLESS STEEL TIBIAL NAIL
ZIMMER, INC.                      510(k) NO: K130595(TRADITIONAL)
ATTN: STEPHEN H MCKELVEY          PHONE NO : 574 372 4944  
P.O. BOX 708                      SE DECISION MADE: 17-SEP-13
WARSAW IN 46581 0708              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VCARE A
IVT MEDICAL LTD                   510(k) NO: K121817(TRADITIONAL)
ATTN: ELI  ORBACH                 PHONE NO : 972 299 32768
POB 6718                          SE DECISION MADE: 17-SEP-13
EFRAT    IS 91435                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAXLOCK EXTREME SYSTEM
ORTHOHELIX SURGICAL DESIGNS, INC. 510(k) NO: K132591(SPECIAL)
ATTN: DEREK  LEWIS                PHONE NO : 330 869 9562  
1065 MEDINA ROAD SUITE 500        SE DECISION MADE: 17-SEP-13
MEDINA OH 44256                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CRYSTALSERT DELIVERY SYSTEM
BAUSCH & LOMB                     510(k) NO: K132593(SPECIAL)
ATTN: YI  GAO                     PHONE NO : 949 521 7933  
30 ENTERPRISE, SUITE 450          SE DECISION MADE: 17-SEP-13
ALISO VIEJO CA 92656 7115         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
EDAN INSTRUMENTS, INC.            510(k) NO: K131830(TRADITIONAL)
ATTN: CHERRY  SUN                 PHONE NO : 867 55 26856469
EQUIPMENTS PARK, NANHAI RD 1019 NOSE DECISION MADE: 17-SEP-13
SHENZHEN    CH 518067             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENT
GE HEALTHCARE                     510(k) NO: K131977(TRADITIONAL)
ATTN: NICOLE  LANDREVILLE         PHONE NO : 289 208 2365  
540 W. NORTHWEST HIGHWAY          SE DECISION MADE: 17-SEP-13
BARRINGTON IL 60010               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 5.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, 6.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, INSERTION GUIDE WITH OBTURATOR, TA
ARTHROCARE CORPORATION            510(k) NO: K132590(SPECIAL)
ATTN: MITCHELL  DHORITY           PHONE NO : 512 358 5995  
7000 West William Cannon Drive    SE DECISION MADE: 17-SEP-13
Austin TX 78735                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ABL90 FLEX ANALYZER
RADIOMETER MEDICAL APS            510(k) NO: K131988(TRADITIONAL)
ATTN: GITTE JUEL  FRIIS           PHONE NO : 453 82 73384
AKANDEVEJ 21                      SE DECISION MADE: 17-SEP-13
BRONSHOJ    DA DK-2700            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEARTSPAN STEERABLE INTRODUCER KIT
MERIT MEDICAL SYSTEMS, INC.       510(k) NO: K132164(SPECIAL)
ATTN: ALINA  STUBBS               PHONE NO : 610 651 5000  
65 GREAT VALLEY PAKRWAY           SE DECISION MADE: 17-SEP-13
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GC-3000E DIGITAL COLPOSCOPE
GOLDCARE MEDITECH CO., LTD        510(k) NO: K122311(TRADITIONAL)
ATTN: JIMMY  WU                   PHONE NO : 626 799 0989  
2600 MISSION STREET STE 100       SE DECISION MADE: 18-SEP-13
SAN MARINO CA 91108               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALPHA-PRO WHITE VARNISH
DENTAL TECHNOLOGIES, INC.         510(k) NO: K124025(TRADITIONAL)
ATTN: PAULA  ERICKSON             PHONE NO : 847 677 5500  
6901 NORTH HAMLIN AVE.            SE DECISION MADE: 18-SEP-13
Lincolnwood IL 60712              510(k) STATEMENT

DEVICE: TRANSTEK GLASS BODY FAT ANALYZER
GUANGDONG TRANSTEK MEDICAL ELECTRO510(k) NO: K131394(SPECIAL)
ATTN: LEO  WANG                   PHONE NO : 086 28 86083300
NO.1 FANGHUA STREET, HI-TECH DISTRSE DECISION MADE: 18-SEP-13
CHENGDU, SICHUAN    CH 610041     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMARTBUILDER SYSTEM (SB1)
OSSTEM IMPLANT CO.,LTD            510(k) NO: K130840(TRADITIONAL)
ATTN: PATRICK  LIM                PHONE NO : 888 678 0001  
85 BEN FAIRLESS DR.               SE DECISION MADE: 18-SEP-13
FAIRLESS HILLS PA 19030           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
RENOVIS SURGICAL TECHNOLOGIES, LLC510(k) NO: K131122(ABBREVIATED)
ATTN: SHARYN  ORTON, PH.D.        PHONE NO : 401 330 8264  
200 HOMER AVE                     SE DECISION MADE: 18-SEP-13
ASHLAND MA 01721                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NAVIOS FLOW CYTOMETER SYSTEM
BECKMAN COULTER, INC.             510(k) NO: K130373(TRADITIONAL)
ATTN: NANCY  NADLER               PHONE NO : 305 380 4191  
11800 SW 147 AVE                  SE DECISION MADE: 18-SEP-13
MIAMI FL 33196 2500               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDLINE ANTI-REFLUX VALVE
MEDLINE INDUSTRIES, INC.          510(k) NO: K132314(TRADITIONAL)
ATTN: MATT  CLAUSEN               PHONE NO : 847 643 4785  
ONE MEDLINE PLACE                 SE DECISION MADE: 18-SEP-13
MUNDELEIN IL 60060                510(k) STATEMENT

DEVICE: APD LUER-LOCK ADAPTER
FRESENSIUS MEDICAL CARE NORTH AMER510(k) NO: K124024(TRADITIONAL)
ATTN: DENISE  OPPERMANN           PHONE NO : 781 699 4479  
920 WINTER ST                     SE DECISION MADE: 19-SEP-13
WALTHAM MA 02451                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUTOLAP SYSTEM
MST – MEDICAL SURGERY TECHNOLOGIES510(k) NO: K131375(TRADITIONAL)
ATTN: JOHN J SMITH, M.D., J.D.    PHONE NO : 202 637 3638  
555 THIRTEENTH STREET NW          SE DECISION MADE: 19-SEP-13
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZIMMER MOTIONLOC SCREW FOR PERIARTICULAR LOCKING PLATE SYSTEM
ZIMMER, INC.                      510(k) NO: K130810(TRADITIONAL)
ATTN: SCOTT M DURLACHER           PHONE NO : 317 569 9500  
9001 WESLEYAN ROAD, STE 200       SE DECISION MADE: 19-SEP-13
INDIANAPOLIS IN 46268             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RENOVIS BIPOLAR HIP SYSTEM
RENOVIS SURGICAL TECHNOLOGIES LLC 510(k) NO: K131354(TRADITIONAL)
ATTN: SHARYN  ORTON               PHONE NO : 401 330 8264  
200 HOMER AVE                     SE DECISION MADE: 19-SEP-13
ASHLAND MA 0172 0000              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OPTICAGE INTERBODY FUSION DEVICE, MODEL 9080-00
INTERVENTIONAL SPINE, INC.        510(k) NO: K132479(SPECIAL)
ATTN: JANE  METCALF               PHONE NO : 949 472 0006  
13700 ALTON PKWY., SUITE 160      SE DECISION MADE: 19-SEP-13
IRVINE CA 92618                   510(k) STATEMENT

DEVICE: PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)
PIPELINE BIOTECHNOLOGY            510(k) NO: K132626(SPECIAL)
ATTN: TERRY  POWELL               PHONE NO : 703 562 9800  
575 EIGHTH AVE, SUITE 1212        SE DECISION MADE: 19-SEP-13
NEW YORK NY 10018                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EQUINOX CO2 LASER
ECLIPSE AESTHETICS, LLC           510(k) NO: K131903(SPECIAL)
ATTN: TOM  O’BRIEN                PHONE NO : 972 380 2911  
13988 Diplomat Dr Suite 160       SE DECISION MADE: 19-SEP-13
Dallas TX 75234                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLES
TORNIER, INC.                     510(k) NO: K132632(SPECIAL)
ATTN: JANELL A COLLEY             PHONE NO : 952 426 7600  
10801 NESBITT AVENUE SOUTH        SE DECISION MADE: 19-SEP-13
BLOOMINGTON MN 55437              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Q-FIX SUTURE ANCHOR,1.8MM AND 2.8MM / DRILL, DRILL GUIDE AND OBTURATOR,1.8MM AND 2.8MM /BONE PUNCH,2.8MM AND KNOT PUSHER
ARTHROCARE CORPORATION            510(k) NO: K132513(SPECIAL)
ATTN: MITCHELL  DHORITY           PHONE NO : 512 358 5995  
7000 WEST WILLIAM CANNON DRIVE    SE DECISION MADE: 19-SEP-13
AUSTIN TX 78735 0000              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT (STANDARD), LOSPA IS ROD- PRE BENT (STANDARD & BU
CORENTEC CO., LTD                 510(k) NO: K132644(SPECIAL)
ATTN: J.S.  DANIEL                PHONE NO : 827 04 3933819
8TH FLOOR CHUNGHO TOWER 748-1 BANPSE DECISION MADE: 19-SEP-13
SEOCHO GU, SEOUL    KN 137-040    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WINGMAN EXTENDABLE TIP SUPPORT CATHETER
REFLOW MEDICAL                    510(k) NO: K132420(SPECIAL)
ATTN: REBECCA K PINE              PHONE NO : 760 809 5178  
1003 Calle Sombra                 SE DECISION MADE: 19-SEP-13
San Clemente CA 92673             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SINUFLUSH LAVAGE SYSTEM
HEDGEPATH, LLC                    510(k) NO: K131177(TRADITIONAL)
ATTN: FRANK E O’DONNELL, JR MD.   PHONE NO : 314 258 6446  
324 S. HYDE PARK AVE. SUITE 350   SE DECISION MADE: 20-SEP-13
TAMPA FL 33606                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MROZ REVERSE OSMOSIS SYSTEM
AMERIWATER                        510(k) NO: K131622(TRADITIONAL)
ATTN: BRIAN R BOWMAN              PHONE NO : 937 461 8833  
1303 STANLEY AVE.                 SE DECISION MADE: 20-SEP-13
DAYTON OH 45404                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMMULITE 2000 ANTI-TG AB CALIBRATION VERIFICATION MATERIAL, IMMULITE 2000 ANTI-TPO AB CALIBRATION VERIFICATIN MATERIAL
SIEMENS HELATHCARE DIAGNOSTICS INC510(k) NO: K132391(ABBREVIATED)
ATTN: GARO  MIMARYAN              PHONE NO : 914 524 3270  
511 BENEDICT AVENUE               SE DECISION MADE: 20-SEP-13
TARRYTOWN NY 10591                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICROPLEX COIL SYSTEM (MCS), VFC
MICROVENTION, INC.                510(k) NO: K132317(SPECIAL)
ATTN: LARAINE  PANGELINA          PHONE NO : 714 247 8150  
1311 VALENCIA AVE                 SE DECISION MADE: 20-SEP-13
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTICHEM IA AND IA PLUS
TECHNO-PATH MANUFACTURING LTD.    510(k) NO: K132091(ABBREVIATED)
ATTN: STEPHANIE G GARTH           PHONE NO : 469 230 0959  
325 BIG ELM ST.                   SE DECISION MADE: 20-SEP-13
HIGHLAND VILLAGE TX 75077         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COROENT SINGLE TAB SYSTEM
NUVASIVE, INC.                    510(k) NO: K131723(TRADITIONAL)
ATTN: JEREMY  MARKOVICH           PHONE NO : 858 309 3783  
7475 LUSK BLVD                    SE DECISION MADE: 20-SEP-13
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA
LEXION MEDICAL, LLC.              510(k) NO: K132203(TRADITIONAL)
ATTN: BERNARD  HORWATH            PHONE NO : 651 231 1761  
4486 TIMBERLINE CT                SE DECISION MADE: 20-SEP-13
VADNAIS HEIGHTS MN 55127          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTICHEM WBT
TECHNO-PATH MANUFACTURING LTD.    510(k) NO: K132174(ABBREVIATED)
ATTN: STEPHANIE G GARTH           PHONE NO : 469 230 0959  
325 BIG ELM ST.                   SE DECISION MADE: 20-SEP-13
HIGHLAND VILLAGE TX 75077         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RELIANCE CERVICAL IBF SYSTEM
RELIANCE MEDICAL SYSTEMS, LLC     510(k) NO: K131429(TRADITIONAL)
ATTN: BRET M BERRY                PHONE NO : 801 295 3280  
P.O. BOX 1693                     SE DECISION MADE: 23-SEP-13
BOUNTIFUL UT 84011                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINER
ENCORE MEDICAL, L.P.              510(k) NO: K130365(TRADITIONAL)
ATTN: TEFFANY  HUTTO              PHONE NO : 512 832 9500  
9800 METRIC BLVD.                 SE DECISION MADE: 23-SEP-13
AUSTIN TX 78758                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BELIMED STEAM STERILIZER MST-V
BELIMED, INC.                     510(k) NO: K130172(ABBREVIATED)
ATTN: JAY  UPCHURCH               PHONE NO : 843 216 7424  
2284 Clements Ferry Road          SE DECISION MADE: 23-SEP-13
Charleston SC 29492               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANATOMIC PEEK CERVICAL FUSION SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K130177(TRADITIONAL)
ATTN: LEE  GRANT                  PHONE NO : 901 396 3133  
1800 PYRAMID PLACE                SE DECISION MADE: 23-SEP-13
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER
DORNIER MEDTECH AMERICA           510(k) NO: K132672(SPECIAL)
ATTN: JOHN  HOFFER                PHONE NO : 770 514 6163  
1155 ROBERTS BLVD.                SE DECISION MADE: 23-SEP-13
KENNESAW GA 30144                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE
MEDTRONIC SOFAMOR DANEK, INC.     510(k) NO: K131888(TRADITIONAL)
ATTN: BECKY  RONNER               PHONE NO : 800 876 3133  
1800 PYRAMID PLACE                SE DECISION MADE: 23-SEP-13
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SFI-BAR
CENDRES & METAUX SA               510(k) NO: K131526(TRADITIONAL)
ATTN: TANJA  BONGNI               PHONE NO : 415 836023 02
RUE DE BOUJEAN 122                SE DECISION MADE: 23-SEP-13
BIEL/BIENNE    SZ 2501            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
BECTON, DICKINSON AND COMPANY     510(k) NO: K132692(SPECIAL)
ATTN: GREGORY P PAYNE, RAC        PHONE NO : 858 795 7890  
10865 ROAD TO THE CURE SUITE 200  SE DECISION MADE: 23-SEP-13
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DESARA MESH, DESARA BLUE
CALDERA MEDICAL, INC.             510(k) NO: K132069(TRADITIONAL)
ATTN: VICKI  GAIL                 PHONE NO : 818 483 7602  
5171 CLARETON DRIVE               SE DECISION MADE: 23-SEP-13
AGOURA HILLS CA 91301             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIAGNOCAM
KALTENBACH & VOIGT GMBH           510(k) NO: K123402(TRADITIONAL)
ATTN: STEFAN  TRAMPLER            PHONE NO : 49 735 10563515
BISMARCHRING 39                   SE DECISION MADE: 24-SEP-13
BIBERACH / RISS    GM 88400       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GE ECHOPAC
GE VINGMED ULTRASOUND AS          510(k) NO: K131685(TRADITIONAL)
ATTN: BRYAN  BEHN                 PHONE NO : 47 330212 80
STRANDPROMENADEN 45 PO BOX 141    SE DECISION MADE: 24-SEP-13
HORTEN    NO N-3191               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VOLUSON I/E
GE HEALTHCARE                     510(k) NO: K131937(TRADITIONAL)
ATTN: BRYAN  BEHN                 PHONE NO : 414 721 4214  
9900 INNOVATION DRIVE             SE DECISION MADE: 24-SEP-13
WAUWATOSA WI 53226                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIXPLORER
SUPERSONIC IMAGINE                510(k) NO: K132274(SPECIAL)
ATTN: JACQUES  SONQUET            PHONE NO : 334 42 992424
510 RUE RENE DESCARTES            SE DECISION MADE: 24-SEP-13
AIX-EN-PROVENCE  CEDEX    FR 13857510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIXPLORER
SUPERSONIC IMAGINE                510(k) NO: K132171(TRADITIONAL)
ATTN: AURELIE  GRUENER            PHONE NO : 33 442 992424
510 RUE RENE DESCARTES            SE DECISION MADE: 24-SEP-13
AIX-EN-PROVENCE    FR 13857       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BRILLIANCE ICT
PHILIPS HEALTHCARE (CLEVELAND)    510(k) NO: K131773(SPECIAL)
ATTN: CATHERINE M CONNELL         PHONE NO : 440 483 5581  
595 MINER RD.                     SE DECISION MADE: 24-SEP-13
CLEVELAND OH 44143                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SHENGGUANG MANUAL WHEELCHAIR
PINGDINGSHAN SHENXING HEALTHCARE T510(k) NO: K131529(TRADITIONAL)
ATTN: WANG  QING                  PHONE NO :
XINXING RD. SOUTH OF INDUSTRIAL PASE DECISION MADE: 24-SEP-13
PINGDINGSHAN CITY, HENAN    CH    510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW

DEVICE: 430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES
DENTALEZ GROUP, STARDENTAL DIVISIO510(k) NO: K130455(TRADITIONAL)
ATTN: JIM  WATKINS                PHONE NO : 717 291 1161  
1816 COLONIAL VILLAGE LN.         SE DECISION MADE: 25-SEP-13
LANCASTER PA 17601                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: I-GEN
MEGAGEN IMPLANT CO., LTD          510(k) NO: K131289(TRADITIONAL)
ATTN: APRIL  LEE                  PHONE NO : 714 525 0114  
325 N PUENTE ST. UNIT B           SE DECISION MADE: 25-SEP-13
BREA CA 92821                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTHREX COMPRESSION PLATES
ARTHREX, INC.                     510(k) NO: K130510(TRADITIONAL)
ATTN: IVETTE  GALMEZ              PHONE NO : 239 643 5553  
1370 CREEKSIDE BLVD.              SE DECISION MADE: 25-SEP-13
NAPLES FL 34108 1945              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NDOHD HIGH DEFINITION IMAGING SYSTEM (NDOHD)
METHODSENSE, INC.                 510(k) NO: K131873(TRADITIONAL)
ATTN: RITA  KING                  PHONE NO : 919 313 3960  
P.O. BOX 110352                   SE DECISION MADE: 25-SEP-13
DURHAM NC 27709                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XVI R5.0
ELEKTA LIMITED                    510(k) NO: K131965(TRADITIONAL)
ATTN: ANDREW  HEDGES              PHONE NO : 441 293654 201
LINAC HOUSE, FLEMING WAY          SE DECISION MADE: 25-SEP-13
CRAWLEY, WEST SUSSEX    UK RH10 9R510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ECLIPSE TREATMENT PLANNING SYSTEM
VARIAN MEDICAL SYSTEMS, INC.      510(k) NO: K131891(TRADITIONAL)
ATTN: PETER J CORONADO            PHONE NO : 650 424 6320  
911 HANSEN WAY                    SE DECISION MADE: 25-SEP-13
PALO ALTO CA 94303                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FINESSIS VIOLET ELEMENT POLYISOPRENE POWDERFREE STERILE SURGICAL GLOVES
LUCENXIA PRESCIENCE AG            510(k) NO: K131751(TRADITIONAL)
ATTN: ROBERT  HILL                PHONE NO : 41 417689 126
RATHAUSSTRASSE 7                  SE DECISION MADE: 25-SEP-13
BAAR, ZUG    SZ 6341              510(k) STATEMENT

DEVICE: POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE
HEBEI HONGSEN PLASTICS TECHNOLOGY 510(k) NO: K131440(TRADITIONAL)
ATTN: CHARLES  SHEN               PHONE NO : 608 217 9358  
5 CAREY STREET                    SE DECISION MADE: 25-SEP-13
PENNINGTON NJ 08534               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
BECKMAN COULTER, INC.             510(k) NO: K121790(TRADITIONAL)
ATTN: KERRIE  OETTER              PHONE NO : 952 368 7858  
1000 LAKE HAZELTINE DR.           SE DECISION MADE: 25-SEP-13
CHASKA MN 55318 1084              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JAZZ SYSTEM
HOGAN LOVELLS US LLP              510(k) NO: K132287(TRADITIONAL)
ATTN: JANICE M HOGAN              PHONE NO : 267 675 4611  
1835 MARKET ST 29TH FL            SE DECISION MADE: 25-SEP-13
PHILADELPHIA PA 19103             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTICHEM P
TECHNO-PATH MANUFACTURING LTD.    510(k) NO: K131992(ABBREVIATED)
ATTN: STEPHANIE G GARTH           PHONE NO : 469 230 0959  
325 BIG ELM ST.                   SE DECISION MADE: 25-SEP-13
HIGHLAND VILLAGE TX 75077         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR
BAYER HEALTHCARE                  510(k) NO: K122370(TRADITIONAL)
ATTN: ROGER  SONNENBURG           PHONE NO : 574 256 3441  
430 SOUTH BEIGER STREET           SE DECISION MADE: 26-SEP-13
MISHAWAKA IN 46544                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM
LIGHTMED CORP.                    510(k) NO: K124043(TRADITIONAL)
ATTN: JOCELYN  LIU                PHONE NO : 886 22688 1726
NO.1-1, LANE1,PAO-AN ST. SEC.3 SHUSE DECISION MADE: 26-SEP-13
NEW TAIPEI CITY    TW 23861       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COSEAL
JILIN CORONADO MEDICAL LTD.       510(k) NO: K131411(TRADITIONAL)
ATTN: ERIC  CHIEN                 PHONE NO : 86 432635 29555
9 South-Western Circle Road FenmanSE DECISION MADE: 26-SEP-13
Jilin    CH 132016                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIRO CT SYSTEM
MOBIUS IMAGING, LLC               510(k) NO: K131431(TRADITIONAL)
ATTN: NORMA  LEMAY                PHONE NO : 978 391 9644  
323 WEST MAIN STREET              SE DECISION MADE: 26-SEP-13
AYER MA 01432                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRECISION ONE LIFECARE; DETECTO; DETECTO
PRECISION ONE LIFECARE, LTD.      510(k) NO: K130952(TRADITIONAL)
ATTN: STEVEN  CHERNOFF            PHONE NO : 425 861 8262  
PO BOX 3515                       SE DECISION MADE: 26-SEP-13
REDMOND WA 98073                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GENII ARC SMART ARGON PROBE
GENII, INC.                       510(k) NO: K130983(TRADITIONAL)
ATTN: TRACY  EBERLY               PHONE NO : 612 716 1209  
3640 PILLSBURY AVE                SE DECISION MADE: 26-SEP-13
MINNEAPOLIS MN 55409              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRANSCEND HEATED HUMIDIFIER
SOMNETICS INTERNATIONAL, INC.     510(k) NO: K131388(TRADITIONAL)
ATTN: MELINDA  SWANSON            PHONE NO : 651 621 1800  
33 5TH AVE NW, STE 500            SE DECISION MADE: 26-SEP-13
NEW BRIGHTON MN 55112             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PERIMETER INTERBODY FUSION DEVICE
MEDTRONIC SOFAMOR DANEK, INC.     510(k) NO: K132700(SPECIAL)
ATTN: ANKIT K SHAH                PHONE NO : 800 876 3133  
1800 PYRAMID PLACE                SE DECISION MADE: 26-SEP-13
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K132654(TRADITIONAL)
ATTN: PATRICK  LYNCH              PHONE NO : 650 694 5658  
685 EAST MIDDLEFIELD ROAD         SE DECISION MADE: 26-SEP-13
MOUNTAIN VIEW CA 94043            510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW

DEVICE: TCM MASSAGER
ANHUI JINJIANQIAO MED-TECH CO,. LT510(k) NO: K130150(TRADITIONAL)
ATTN: FIELD  FU                   PHONE NO : 86 755 86069197
05C.FUHAI KANGLE BUILDING NANSHAN SE DECISION MADE: 26-SEP-13
SHENZHEN, GUANGDONG    CH 518000  510(k) STATEMENT

DEVICE: PRIMI SUPPORT CATHETER
THERMOPEUTIX INC.                 510(k) NO: K132701(SPECIAL)
ATTN: JASON  FORD                 PHONE NO : 858 549 1760  
9951B BUSINESSPARK AVE            SE DECISION MADE: 26-SEP-13
SAN DIEGO CA 92131                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI)
GE MEDICAL SYSTEMS SCS            510(k) NO: K131885(TRADITIONAL)
ATTN: MOUNIR  ZAOUALI             PHONE NO : 33 130 704539
283 RUE DE LA MINIERE             SE DECISION MADE: 26-SEP-13
BUC    FR 78530                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NANOCROSS ELITE .14" OVER-THE-WIRE PTA, BALLOON DILATION CATHETER
EV3 INC                           510(k) NO: K132777(TRADITIONAL)
ATTN:                             PHONE NO :
3033 CAMPUS DRIVE                 SE DECISION MADE: 26-SEP-13
PLYMOUTH MN 55441                 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW

DEVICE: PROTURA COUCH SOFTWARE
MED-TEC, INC. D/B/A CIVCO MEDICAL 510(k) NO: K132084(TRADITIONAL)
ATTN: AMANDA  STAHLE              PHONE NO : 319 248 6628  
1401 8TH STREET SE                SE DECISION MADE: 26-SEP-13
ORANGE CITY IA 51041              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COCHLEAR BAHA  4 SOUND PROCESSOR
COCHLEAR AMERICAS                 510(k) NO: K132278(SPECIAL)
ATTN: SEAN  BUNDY                 PHONE NO : 303 790 9010  
13059 EAST PEAKVIEW AVENUE        SE DECISION MADE: 26-SEP-13
CENTENNIAL CO 80111               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ESTEYA
NUCLETRON B.V.                    510(k) NO: K132092(TRADITIONAL)
ATTN: LU ANNE  JOHNSON            PHONE NO : 715 403 5321  
1917 29 3/4 AVE.                  SE DECISION MADE: 26-SEP-13
RICE LAKE WI 54868                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PHILIPS DXL 12/16-LEAD ECG ALGORITHM
PHILIPS MEDICAL SYSTEMS           510(k) NO: K132068(SPECIAL)
ATTN: THERESA  POOLE              PHONE NO : 978 659 7621  
3000 Minuteman Rd                 SE DECISION MADE: 26-SEP-13
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS
ORFIT INDUSTRIES NV               510(k) NO: K131795(TRADITIONAL)
ATTN: EDDY  MARIVOET              PHONE NO : 320 33 262026
VOSVELD 9A                        SE DECISION MADE: 26-SEP-13
WIJNEGEM    BE 2110               510(k) STATEMENT

DEVICE: CG+ ARROW JACC POWERED BY ARROW VPS STYLET
ARROW INTERNATIONAL(SUBSIDIARY OF 510(k) NO: K132133(SPECIAL)
ATTN: JULIE  LAWSON               PHONE NO : 610 378 0131  
2400 BERNVILLE RD.                SE DECISION MADE: 26-SEP-13
READING PA 19605                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRINITY ACETABULAR SYSTEM
CORIN USA                         510(k) NO: K131647(TRADITIONAL)
ATTN: DIANA L MARTONE             PHONE NO : 813 977 4469  
5670 W. CYPRESS ST. SUITE C       SE DECISION MADE: 27-SEP-13
TAMPA FL 33607                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THEYFIT MALE CONDOM
THEYFIT                           510(k) NO: K122219(TRADITIONAL)
ATTN: PENNY  NORTHCUTT            PHONE NO : 678 428 6978  
717 LAKEGLEN DRIVE                SE DECISION MADE: 27-SEP-13
SUWANEE GA 30024                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EASY-GRAFT
DEGRADABLE SOLUTIONS AG           510(k) NO: K131385(TRADITIONAL)
ATTN: DEBORAH  LAVOIE GRAYESKI    PHONE NO : 703 562 9800  
901 KING STREET SUITE 101         SE DECISION MADE: 27-SEP-13
ALEXANDRIA VA 22314               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COOK CERVICAL RIPENING BALLOON
COOK, INC.                        510(k) NO: K131206(TRADITIONAL)
ATTN: CHIRS  KILANDER             PHONE NO : 812 339 2235  
750 DANIELS WAY                   SE DECISION MADE: 27-SEP-13
Blmgtn IN 47404                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MATCH POINT SYSTEM(TM), SURGICASE CONNECT, MATCH POINT SYSTEM(TM) GUIDES
MATERIALISE N.V.                  510(k) NO: K131559(TRADITIONAL)
ATTN: ALEXANDRA  RAZZHIVINA       PHONE NO : 32 1639 6280
TECHNOLOGIELAAN 15                SE DECISION MADE: 27-SEP-13
LEUVEN    BE 3001                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BESTFIT2 NASAL MASK
CURATIVE MEDICAL INC.             510(k) NO: K130663(TRADITIONAL)
ATTN: AMY  MCKINNEY               PHONE NO : 979 236 1622  
6518 TAMARIND SKY LN.             SE DECISION MADE: 27-SEP-13
FULSHEAR TX 77441                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STRYKER NAV3I PLATFORM
STRYKER CORPORATE                 510(k) NO: K130874(TRADITIONAL)
ATTN: LILIAN  ECKERT              PHONE NO : 49 761 4512117
BOETZINGER STR. 41                SE DECISION MADE: 27-SEP-13
FREIBURG, BADEN-WUERTTEMBERG    GM510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MASTERTORQUE LUX 8900 L
KALTENBACH & VOIGT GMBH           510(k) NO: K130560(TRADITIONAL)
ATTN: STEFAN  TRAMPLER            PHONE NO : 49 7351 563515
BISMARCKRING 39                   SE DECISION MADE: 27-SEP-13
BIBERACH / RISS    GM 88400       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KLEIN TOUCH PUMP AND DISPOSABLE TUBING SET
HK SURGICAL, INC.                 510(k) NO: K123822(TRADITIONAL)
ATTN: CLARE  BENNETT              PHONE NO : 949 369 0101  
1271 PUERTA DEL SOL               SE DECISION MADE: 27-SEP-13
SAN CLEMENTE CA 92673             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXTRICARE 100CC/ 250CC/ 400CC CANISTERS
DEVON MEDICAL                     510(k) NO: K132252(SPECIAL)
ATTN: RUTH  WU                    PHONE NO : 610 757 4103  
1100 FIRST AVENUE SUITE 202       SE DECISION MADE: 27-SEP-13
KING OF PRUSSIA PA 19406          510(k) STATEMENT

DEVICE: MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING
MEDTRONIC INC.                    510(k) NO: K132030(TRADITIONAL)
ATTN: CHECHAMMA  VARUGHESE        PHONE NO : 763 523 2364  
8200 CORAL SEA STREET MS MVS11    SE DECISION MADE: 27-SEP-13
MOUNDS VIEW MN 55112              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LARGE (6") ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6") ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYST
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K131618(TRADITIONAL)
ATTN: JOHN  CHESNEY               PHONE NO : 734 741 6410  
6200 JACKSON RD.                  SE DECISION MADE: 27-SEP-13
ANN ARBOR MI 48103                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VOLCANO PREVIEW FORWARD-LOOKING IVUS SYSTEM
VOLCANO CORPORATION               510(k) NO: K132659(SPECIAL)
ATTN: MARCUS  GARCIA              PHONE NO : 978 439 3312  
1 FORTUNE DRIVE                   SE DECISION MADE: 27-SEP-13
BILLERICA MA 01821                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR
HANSEN MEDICAL, INC.              510(k) NO: K132369(SPECIAL)
ATTN: HASSAN  LABAY               PHONE NO : 650 404 5888  
800 EAST MIDDLEFIELD ROAD         SE DECISION MADE: 27-SEP-13
MOUNTAIN VIEW CA 94043            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MORCELLEX SIGMA GENERATOR
ETHICON, INC.                     510(k) NO: K131656(TRADITIONAL)
ATTN: SARAH  MCMANUS              PHONE NO : 908 218 2954  
P.O. BOX 151 ROUTE 22 WEST        SE DECISION MADE: 27-SEP-13
SOMERVILLE NJ 08876 0151          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING
US VASCULAR, LLC                  510(k) NO: K131860(TRADITIONAL)
ATTN: E.J.  SMITH                 PHONE NO : 888 729 9674  
1468 HARWELL AVE                  SE DECISION MADE: 27-SEP-13
CROFTON MD 21114                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NMI COAXIAL MICROINTRODUCER SET
NAVILYST MEDICAL, INC.            510(k) NO: K132713(SPECIAL)
ATTN: MICHAEL P HANLEY            PHONE NO : 508 658 7983  
26 FOREST STREET                  SE DECISION MADE: 27-SEP-13
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTHREX UNIVERS APEX
ARTHREX, INC.                     510(k) NO: K131633(TRADITIONAL)
ATTN: COURTNEY  SMITH             PHONE NO : 239 643 5553  
1370 CREEKSIDE BLVD.              SE DECISION MADE: 27-SEP-13
NAPLES FL 34108 1945              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TYBER MEDICAL INTERBODY SYSTEM; ACIF, ALIF, PLIF, TLIF, DLIF
TYBER MEDICAL LLC                 510(k) NO: K130573(TRADITIONAL)
ATTN: JEFF  TYBER                 PHONE NO : 303 717 5060  
89 HEADQUARTERS PLAZA NORTH #1464 SE DECISION MADE: 30-SEP-13
MORRISTOWN NJ 07960               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOC
ACUMED LLC                        510(k) NO: K131845(TRADITIONAL)
ATTN: KARA  BUDOR                 PHONE NO : 503 207 1412  
5885 NW CORNELIUS PASS RD.        SE DECISION MADE: 30-SEP-13
HILLSBORO OR 97124 9432           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WIRED MOUTH PROTECTOR (WMP)
ELBA LABORATORIES, INC.           510(k) NO: K131396(TRADITIONAL)
ATTN: RICHARD A HAMER             PHONE NO : 248 586 8433  
780 W. 8 MILE RD                  SE DECISION MADE: 30-SEP-13
FERNDALE MI 48220                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTEM
NEOS SURGERY S.L.                 510(k) NO: K132044(TRADITIONAL)
ATTN: CHERITA  JAMES              PHONE NO : 703 562 9800  
901 KING STREET SUITE 101         SE DECISION MADE: 30-SEP-13
ALEXANDRIA VA 22314               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPY
BEST MEDICAL INTERNATIONAL, INC.  510(k) NO: K132097(TRADITIONAL)
ATTN: DHARMENDRA  THAKUR          PHONE NO : 703 451 2378  
7643 FULLERTON RD.                SE DECISION MADE: 30-SEP-13
SPRINGFIELD VA 22153              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SHASER HRS2 RX HAIR REMOVAL SYSTEM
SHASER, INC.                      510(k) NO: K132266(TRADITIONAL)
ATTN: ANTHONY  BURNS              PHONE NO : 781 995 2246  
10 MAGUIRE RD STE 120 BUILDING ONESE DECISION MADE: 30-SEP-13
LEXINGTON MA 02421                510(k) SUMMARY AVAILABLE FROM FDA

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance

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