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U.S. Department of Health and Human Services

Medical Devices

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October 2012 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD October 2012


DEVICE: INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEM
MEDELA AG                         510(k) NO: K113678(TRADITIONAL)
ATTN: ADRIENNE  LENZ              PHONE NO : 262 290 0023   
W324S3649 COUNTY ROAD E           SE DECISION MADE: 01-OCT-12
DOUSMAN WI 53118                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SERF ABLATION SYSTEM SERF ABLATION NEEDLE
THERMEDICAL                       510(k) NO: K120116(TRADITIONAL)
ATTN: JANICE M HOGAN              PHONE NO : 267 675 4611   
1835 MARKET STREET 29TH FLOOR     SE DECISION MADE: 01-OCT-12
PHILADELPHIA PA 19103             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NOVATION LPI PRIME FEMORAL STEM
EXACTECH, INC.                    510(k) NO: K121684(TRADITIONAL)
ATTN: VLADISLAVA  ZAITSEVA        PHONE NO : 352 377 1140   
2320 N.W. 66TH CT.                SE DECISION MADE: 01-OCT-12
GAINESVILLE FL 32653              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOLSTICE CROSS CONNECTOR
LIFE SPINE                        510(k) NO: K120998(SPECIAL)
ATTN: RANDY  LEWIS                PHONE NO : 847 884 6117   
2401 W. HASSELL RD. SUITE 1535    SE DECISION MADE: 01-OCT-12
HOFFMAN ESTATES IL 60169          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AFT PROXIMAL HUMERUS FRACTURE PLATE
SHOULDER OPTIONS, INC.            510(k) NO: K121672(TRADITIONAL)
ATTN: JOHN  KAPITAN               PHONE NO : 704 512 0000   
100 E. SOUTH MAIN ST. P.O. BOX 145SE DECISION MADE: 01-OCT-12
WAXHAW NC 28173                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPEEDICATH COMPACT SET (12/18 FR)
COLOPLAST A/S                     510(k) NO: K121458(TRADITIONAL)
ATTN: BRIAN  SCHMIDT              PHONE NO : 612 302 4987   
1601 WEST RIVER ROAD NORTH        SE DECISION MADE: 01-OCT-12
MINNEAPOLIS MN 55411              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOPATH XCEL BLADELESS TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH XCEL BLUNT TIP TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH
ETHICON ENDO-SURGERY, LLC         510(k) NO: K122511(TRADITIONAL)
ATTN: EMILY  KRUETZKAMP           PHONE NO : 513 337 1546   
4545 CREEK ROAD                   SE DECISION MADE: 01-OCT-12
CINCINNATI OH 45242               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AXSOS DISTAL LATERAL FEMUR TS LONG PLATES
HOWMEDICA OSTEONICS CORP DBA STRYK510(k) NO: K122308(SPECIAL)
ATTN: STEPHANIE M FITTS           PHONE NO : 201 831 5405   
325 CORPORATE DRIVE               SE DECISION MADE: 01-OCT-12
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORTHOLOC 3DI ANKLE FUSION PLATING SYSTEM
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K121425(TRADITIONAL)
ATTN: SAMIR  IBRAHIM              PHONE NO : 901 867 9971   
5677 AIRLINE RD.                  SE DECISION MADE: 01-OCT-12
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TANGORS MULTIFUNCTIONAL POSTERIOR SYSTEM
ULRICH GMBH & CO. KG              510(k) NO: K120891(TRADITIONAL)
ATTN: HANS  STOVER                PHONE NO : 636 519 0268   
612 TRADE CENTER BLVD             SE DECISION MADE: 01-OCT-12
CHESTERFIELD MO 63005             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REVERE STABILIZATION SYSTEM
GLOBUS MEDICAL INC.               510(k) NO: K122226(SPECIAL)
ATTN: MERIAM  YOUSSEF             PHONE NO : 610 930 1800   
2560 GENERAL ARMISTEAD AVE.       SE DECISION MADE: 01-OCT-12
AUDUBON PA 19403                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMARTLUX
MEDMIX CO., LTD                   510(k) NO: K120460(TRADITIONAL)
ATTN: PETER  CHUNG                PHONE NO : 412 684 3976   
300 ATWOOD                        SE DECISION MADE: 01-OCT-12
PITTSBURGH PA 15213               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AOS SOLID LOCKING LAG SCREW, AOS TELESCOPING LAG SCREW
ADVANCED ORTHOPAEDIC SOLUTIONS, IN510(k) NO: K120148(TRADITIONAL)
ATTN: JULIE  GLENDRANGE           PHONE NO : 310 533 9966   
386 Beech Ave. Unit B6            SE DECISION MADE: 02-OCT-12
TORRANCE CA 90501                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 6-8MM X 30 MM INTRAFIX PEEK TAPERED SCREW 7-9MM X 30MM INTRAFIX PEEK TAPERED SCREW 8-10MM X 30 MM INTRAFIX PEEK TAPERED
DEPUY MITEK INC., A JOHNSON AND JO510(k) NO: K122123(TRADITIONAL)
ATTN: JULIE  VAFIDES              PHONE NO : 508 977 6645   
325 PARAMOUNT DRIVE               SE DECISION MADE: 02-OCT-12
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPEEDICATH COMPACT SET (12 FR)
COLOPLAST CORP.                   510(k) NO: K121457(TRADITIONAL)
ATTN: BRIAN  SCHMIDT              PHONE NO : 612 302 4987   
1601 WEST RIVER RD NORTH          SE DECISION MADE: 02-OCT-12
MINNEAPOLIS MN 55411              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ESON NASAL MASK
FISHER & PAYKEL HEALTHCARE LIMITED510(k) NO: K121597(TRADITIONAL)
ATTN: JAMES  THOMPSON             PHONE NO : 64 9574 0123
15 MAURICE PAYKEL PLACE EAST TAMAKSE DECISION MADE: 02-OCT-12
AUCKLAND    NZ 2013               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET
APPLIED MEDICAL                   510(k) NO: K122619(TRADITIONAL)
ATTN: JESSICA  CHO                PHONE NO : 949 713 8470   
22872 AVENIDA EMPRESA             SE DECISION MADE: 02-OCT-12
RANCHO SANTA MARGARITA CA 92688   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SHIGA TOXIN CHEK
TECHLAB INC., CORPORATE RESEARCH C510(k) NO: K121411(TRADITIONAL)
ATTN: DONNA T LINK                PHONE NO : 540 953 1664   
2001 KRAFT DR.                    SE DECISION MADE: 02-OCT-12
BLACKSBURG VA 24060 6358          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SHIGA TOXIN QUIK CHEK
TECHLAB INC., CORPORATE RESEARCH C510(k) NO: K121364(TRADITIONAL)
ATTN: DONNA T LINK                PHONE NO : 540 953 1664   
2001 KRAFT DR.                    SE DECISION MADE: 02-OCT-12
BLACKSBURG VA 24060 6358          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PENUMBRA PUMP MAX (110VAC), PENUMBRA PUMP MAX (230VAC), PENUMBAR PUMP MAX CANISTER/TUBING
PENUMBRA, INC.                    510(k) NO: K122756(SPECIAL)
ATTN: SETH  SCHULMAN              PHONE NO : 510 748 3247   
1351 Harbor Bay Parkway           SE DECISION MADE: 02-OCT-12
Alameda CA 94502                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING
AIRSTRIP TECHNOLOGIES, LP         510(k) NO: K122133(SPECIAL)
ATTN:                             PHONE NO : 
335 E. SONTERRA BLVD. SUITE 200   SE DECISION MADE: 02-OCT-12
SAN ANTONIO TX 78258              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ULTHERA SYSTEM
ULTHERA, INC.                     510(k) NO: K121700(TRADITIONAL)
ATTN: SUZON  LOMMEL               PHONE NO : 480 619 4069   
2150 South Country Club Drive SuitSE DECISION MADE: 02-OCT-12
Mesa AZ 85210                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GIRAFFE AND PANDA WARMERS
OHMEDA MEDICAL, A DIVISION OF DATE510(k) NO: K122267(SPECIAL)
ATTN: AGATA  ANTHONY              PHONE NO : 410 888 5200   
8880 GORMAN RD.                   SE DECISION MADE: 02-OCT-12
LAUREL MD 20723                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORTHOFIX SCREW
BONAFIX SURGICAL AND DENTAL IMPLAN510(k) NO: K113650(TRADITIONAL)
ATTN: JUAN  TEZAK                 PHONE NO : 561 789 2411   
118 W. PRIVE CR.                  SE DECISION MADE: 03-OCT-12
DELRAY TEZAK FL 33445             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERRAD CHEMIAL INDICATOR STRIP MODEL 14100
ADVANCED STERILIZATION PRODUCTS   510(k) NO: K111518(TRADITIONAL)
ATTN: NANCY  CHU                  PHONE NO : 949 453 6435   
33 TECHNOLOGY DR.                 SE DECISION MADE: 03-OCT-12
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERRAD SEALSURE CHEMICAL INDICATOR TAPE MODEL 14202
ADVANCED STERILIZATION PRODUCTS   510(k) NO: K111519(TRADITIONAL)
ATTN: NANCY  CHU                  PHONE NO : 949 453 6435   
33 TECHNOLOGY DR.                 SE DECISION MADE: 03-OCT-12
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NIRVANA B PERSONAL LUBRICANT
CHURCH & DWIGHT CO., INC.         510(k) NO: K120751(TRADITIONAL)
ATTN: EMILY  PEREZ                PHONE NO : 609 688 5347   
469 NORTH HARRISON STREET         SE DECISION MADE: 03-OCT-12
PRINCETON NJ 08543                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II
ELITECHGROUP                      510(k) NO: K122858(TRADITIONAL)
ATTN: DEBRA K HUTSON              PHONE NO : 425 482 5174   
21720 23RD DR SE SUITE 150        SE DECISION MADE: 03-OCT-12
BOTHELL WA 98021                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIGAFIX INTERFERENCE SCREW
SBM SCIENCES FOR BIO MATERIALS    510(k) NO: K122228(SPECIAL)
ATTN: DENIS  CLEMENT              PHONE NO : 335 624 22101
ZI DU MONGE                       SE DECISION MADE: 03-OCT-12
LOURDES    FR 65100               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HT-WEDGE
D.T. DAVIS ENTERPRISES LTD. T/A HO510(k) NO: K121287(TRADITIONAL)
ATTN: SUSAN  PAVELKO              PHONE NO : 610 694 9600   
513 SOUTH CLEWELL STREET          SE DECISION MADE: 03-OCT-12
BETHLEHEM PA 18015                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS
MITSUBISHI HEAVY INDUSTRIES, LTD. 510(k) NO: K122450(TRADITIONAL)
ATTN: YOICHI  WAKIYAMA            PHONE NO : 818 229 12135
4-6-22 KAN-ON-SHIN-MACHI NISHI-KU SE DECISION MADE: 03-OCT-12
HIROSHIMA-SHI    JA 733-8553      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GEMINUS FOSSA SPECIFIC PLATE SYSTEM
SKELETAL DYNAMICS, LLC            510(k) NO: K122737(SPECIAL)
ATTN: ANA M ESCAGEDO              PHONE NO : 305 596 7585   
8905 SW 87 AVENUE, SUITE 201      SE DECISION MADE: 03-OCT-12
MIAMI FL 33176                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K122599(TRADITIONAL)
ATTN: KIRA  GORDON                PHONE NO : 914 524 2996   
511 BENEDICT AVE.                 SE DECISION MADE: 03-OCT-12
TARRYTOWN NY 10591                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIDA VI.8 DIAGNOSTIC ULTRASOUND GM-72P00A, L13-5V1 TRANSDUCER
PANASONIC HEALTHCARE CO., LTD.    510(k) NO: K122009(TRADITIONAL)
ATTN: RAM  BEDI                   PHONE NO : 425 985 8670   
2425 SQUAK MOUNTAIN LOOP SW       SE DECISION MADE: 03-OCT-12
ISSAQUAH WA 98027                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUF
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K120125(TRADITIONAL)
ATTN: ROBIN  MARTIN               PHONE NO : 414 336 9228   
8200 WEST TOWER AVE.              SE DECISION MADE: 03-OCT-12
Milwaukee WI 53223                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: EK DELIVERY DEVICE
TDAK MEDICAL, INC                 510(k) NO: K121579(TRADITIONAL)
ATTN: GREG  HOLLAND               PHONE NO : 949 262 0411   
3722 AVE. SAUSALITO               SE DECISION MADE: 03-OCT-12
IRVINE CA 92606                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMARTBUILDER SYSTEM
OSSTEM IMPLANT CO.,LTD            510(k) NO: K120951(TRADITIONAL)
ATTN: PATRICK  LIM                PHONE NO : 888 678 0001   
85 BEN FAIRLESS DR.               SE DECISION MADE: 03-OCT-12
FAIRLESS HILLS PA 19030           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LOGIQ S7 EXPERT, LOGIQ S7 PRO
GE HEALTHCARE                     510(k) NO: K122114(TRADITIONAL)
ATTN: BRYAN  BEHN                 PHONE NO : 414 721 4214   
9900 INNOVATION DRIVE             SE DECISION MADE: 03-OCT-12
WAUWATOSA WI 53226                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K122862(SPECIAL)
ATTN: CHRIS  MCKEE                PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 03-OCT-12
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELEGANT NITRILE POWDER FREE EXAMINATION GLOVE BLUE VIOLET
PROFIT POINT MANUFACTURING SDN BHD510(k) NO: K120110(TRADITIONAL)
ATTN: ROBERT  HILL                PHONE NO : 607 787 9786
LOT PTD 27735 (PLO 9) 26624 (PLO 1SE DECISION MADE: 04-OCT-12
KLUANG    MY 86000                510(k) STATEMENT

DEVICE: ACTIVE SCREW BONE SCREW
INTELLIGENT IMPLANT SYSTEMS, LLC  510(k) NO: K121682(TRADITIONAL)
ATTN: MICHAEL J NUTT              PHONE NO : 704 424 1009   
3300 INTERNATIONAL AIRPORT DRIVE SSE DECISION MADE: 04-OCT-12
CHARLOTTE NC 28208                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HERO II DENTAL IMPLANT SYSTEM, IS DENTAL IMPLANT SYSTEM
KJ MEDITECH CO., LTD              510(k) NO: K121047(TRADITIONAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 869 3080   
951 STARBUCK ST. UNIT J           SE DECISION MADE: 04-OCT-12
FULLERTON CA 92833                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATOR
ADVANCED STERILIZATION PRODUCTS   510(k) NO: K122044(SPECIAL)
ATTN: NANCY  CHU                  PHONE NO : 949 453 6435   
33 TECHNOLOGY DRIVE               SE DECISION MADE: 04-OCT-12
Irvine CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MIXJECT WITH SPRAY HEAD
MEDIMOP MEDICAL PROJECTS, LTD.    510(k) NO: K122023(TRADITIONAL)
ATTN: LLANIT  GOLDGRABER          PHONE NO : 972 977 57122
17 HATIDHAR ST.                   SE DECISION MADE: 04-OCT-12
RAANANA    IS 43665               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NIRVANA A PERSONAL LUBRICANT
CHURCH & DWIGHT CO., INC.         510(k) NO: K120706(TRADITIONAL)
ATTN: EMILY  PEREZ                PHONE NO : 609 688 5347   
469 NORTH HARRISON STREET         SE DECISION MADE: 04-OCT-12
PRINCETON NJ 08543                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRYPTIK CC ANTERIOR INTERSOMATIC CERVICAL CAGE
SPINEART                          510(k) NO: K122366(SPECIAL)
ATTN: FRANK  PENNESI              PHONE NO : 412 279 94025
COINTRIN 20 ROUTE DE PRE-BOIS CP18SE DECISION MADE: 04-OCT-12
GENEVA    SZ 1215                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XPEED ANY RIDGE INTERNAL IMPLANT SYSTEM
MEGAGEN IMPLANT CO., LTD          510(k) NO: K122231(SPECIAL)
ATTN: APRIL  LEE                  PHONE NO : 714 525 0114   
325 N PUENTE ST. UNIT B           SE DECISION MADE: 04-OCT-12
BREA CA 92821                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MINISPIR
MIR MEDICAL INTL. RESEARCH SRL    510(k) NO: K122384(SPECIAL)
ATTN: GERDA  VAN HOUTS            PHONE NO : 390 622 754777
VIA DEL MAGGIOLINO 125            SE DECISION MADE: 04-OCT-12
ROMA    IT 00155                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Z-MED Z-MED II
NUMED, INC.                       510(k) NO: K122012(TRADITIONAL)
ATTN: NICHELLE  LAFLESH           PHONE NO : 315 328 4491   
2880 MAIN ST.                     SE DECISION MADE: 04-OCT-12
HOPKINTON NY 12965                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALAMO T
ALLIANCE PARTNERS, LLC            510(k) NO: K120401(TRADITIONAL)
ATTN: JENNIFER  PALINCHIK         PHONE NO : 440 933 8850   
33490 PIN OAK PARKWAY             SE DECISION MADE: 05-OCT-12
AVON LAKE OH 44012                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BTL ELITE
BTL INDUSTRIES, INC               510(k) NO: K120093(TRADITIONAL)
ATTN: MARCY  MOORE                PHONE NO : 919 363 2432   
16 APPLETON STREET                SE DECISION MADE: 05-OCT-12
WALTHAM MA 02453                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REPROCESSED SURGICAL ELECTRIC INSTRUMENT
STERILMED, INC.                   510(k) NO: K120040(TRADITIONAL)
ATTN: JASON  SKRAMSTED            PHONE NO : 763 488 3483   
11400 73RD AVE. NORTH, No. 100    SE DECISION MADE: 05-OCT-12
MAPLE GROVE MN 55369              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMITH & NEPHEW RADIOPAQUE TRIAL NECKS
SMITH & NEPHEW, INC.              510(k) NO: K113039(TRADITIONAL)
ATTN: NATALIE P WILLIAMS          PHONE NO : 901 399 5161   
7135 GOODLETT FARMS PARKWAY       SE DECISION MADE: 05-OCT-12
CORDOVA TN 38016                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EPOC CHLORIDE TEST AND EPOC CREATININE TEST
EPOCAL, INC.                      510(k) NO: K113726(TRADITIONAL)
ATTN: ROY  LAYER                  PHONE NO : 613 738 6192
2060 WALKLEY RD.                  SE DECISION MADE: 05-OCT-12
OTTAWA, ONTARIO    CA K1G-3P5     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BENCOX II STEM, BENCOX METAL HEAD
CORENTEC CO., LTD                 510(k) NO: K122099(SPECIAL)
ATTN: J.S.  DANIEL                PHONE NO : 82 07 43933819
11TH CHUNGHO TOWER, 748-1 BANPO 1 SE DECISION MADE: 05-OCT-12
SEOCHO GU, SEOUL    KS 137-040    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SIMPLE T NASAL MASK
RESPIRONICS, INC.                 510(k) NO: K121631(SPECIAL)
ATTN: MICHELLE  BRINKER           PHONE NO : 724 387 4146   
1001 MURRY RIDGE LN.              SE DECISION MADE: 05-OCT-12
MURRYSVILLE PA 15668              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TBS INSIGHT
MEDIMAPS GROUP SA                 510(k) NO: K121716(TRADITIONAL)
ATTN: CHRISTOPHE  LELONG          PHONE NO : 41 22 8848644
18 CHEMIN DES AULX                SE DECISION MADE: 05-OCT-12
PLAN LES OUATES    SZ 1228        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MD211G3 21.3" DIAGNOSTIC IMAGING LCD MONITOR
PRODIGY TECHNOLOGY CONSULTANT CO.,510(k) NO: K122843(TRADITIONAL)
ATTN: ANGUS  HSU                  PHONE NO : 886 22 6037288
1F, NO. 181, SEC 2, WUNHUA 1ST RD.SE DECISION MADE: 05-OCT-12
TAIPEI    TW                      510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: PORTA 100HF
JOB CORPORATION                   510(k) NO: K122697(TRADITIONAL)
ATTN: TAKAHIRO  HARUYAMA          PHONE NO : 424 247 9447   
1411 W. 190TH STREET SUITE 120    SE DECISION MADE: 05-OCT-12
GARDENA CA 92048                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM
KCI USA, INC. (KINETIC CONCEPTS, I510(k) NO: K120499(TRADITIONAL)
ATTN: MARGARET  MARSH             PHONE NO : 210 255 6481   
6203 FARINON DRIVE                SE DECISION MADE: 05-OCT-12
SAN ANTONIO TX 78249              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: C1-6-D ULTRASOUND TRANSDUCER
GE HEALTHCARE                     510(k) NO: K122921(SPECIAL)
ATTN: BRYAN  BEHN                 PHONE NO : 414 721 4214   
9900 W INNOVATION DRIVE           SE DECISION MADE: 05-OCT-12
WAUWATOSA WI 53226                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DFP4343C7
MDI CONSULTANTS, INC.             510(k) NO: K122589(TRADITIONAL)
ATTN: JIGAR  SHAH                 PHONE NO : 516 482 9001   
55 NORTHERN BOULEVARD SUITE 200   SE DECISION MADE: 05-OCT-12
GREAT NECK NY 11021               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TIGER SPINE SYSTEM
CORELINK LLC                      510(k) NO: K121728(SPECIAL)
ATTN: J.D.  WEBB                  PHONE NO : 512 388 0199   
1001 OAKWOOD BLVD                 SE DECISION MADE: 05-OCT-12
ROUND ROCK TX 78681               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT
ALFA WASSERMANN DIAGNOSTIC TECHNOL510(k) NO: K122757(TRADITIONAL)
ATTN: HYMAN  KATZ, PH.D.          PHONE NO : 973 852 0158   
4 HENDERSON DRIVE                 SE DECISION MADE: 05-OCT-12
WEST CALDWELL NJ 07006            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CVUE ADVANCED HYDRA VUE
UNILENS CORP., USA                510(k) NO: K121652(TRADITIONAL)
ATTN: ALAN J FRAZER               PHONE NO : 727 544 2531   
10431 72ND ST. NORTH              SE DECISION MADE: 05-OCT-12
LARGO FL 33777                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CORIN TRIFIT TS HIP
CORIN USA                         510(k) NO: K121563(TRADITIONAL)
ATTN: LUCINDA  GERBER             PHONE NO : 813 977 4469   
10500 UNIVERSITY CENTER DRIVE SUITSE DECISION MADE: 05-OCT-12
TAMPA FL 33612                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE)
VILEX, INC.                       510(k) NO: K112837(TRADITIONAL)
ATTN: SYLVIA  SOUTHARD            PHONE NO : 931 474 7550   
111 MOFFITT STREET                SE DECISION MADE: 09-OCT-12
MCMINNVILLE TN 37110              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY T
COVIDIEN                          510(k) NO: K122531(SPECIAL)
ATTN: TED  KUHN                   PHONE NO : 303 305 2272   
6135 GUNBARREL AVE.               SE DECISION MADE: 09-OCT-12
BOULDER CO 80021                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REMSTAR SE
RESPIRONICS, INC.                 510(k) NO: K122769(SPECIAL)
ATTN: FRANK  KADI                 PHONE NO : 724 387 4134   
1740 GOLDEN MILE HIGHWAY          SE DECISION MADE: 09-OCT-12
MONROEVILLE PA 15146              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CROSS-OVER ACETABULAR SHELL & LINER
STELKAST COMPANY                  510(k) NO: K122773(SPECIAL)
ATTN: DAVID  STUMPO               PHONE NO : 724 731 2208   
200 HIDDEN VALLEY RD.             SE DECISION MADE: 09-OCT-12
MCMURRAY PA 15317                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AXCESS SOFT TIP WIRE GUIDE
WILSON-COOK MEDICAL INC.          510(k) NO: K122816(SPECIAL)
ATTN: DORIS A HAWKS               PHONE NO : 336 744 0157   
4900 Bethania Station Rd          SE DECISION MADE: 09-OCT-12
Winston Salem NC 27105            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RADREX-I, SW V4.00 MODEL DRAD-3000E
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K122842(SPECIAL)
ATTN: CHARLEMAGNE  CHUA           PHONE NO : 714 669 7896   
2441 MICHELLE DR.                 SE DECISION MADE: 09-OCT-12
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEXTRA TI HAMMERTOE CORRECTION SYSTEM
NEXTREMITY SOLUTIONS, LLC         510(k) NO: K122031(TRADITIONAL)
ATTN: ARTHUR A ALFARO             PHONE NO : 732 683 9304   
167 Stone Hill Rd.                SE DECISION MADE: 09-OCT-12
Colts Neck NJ 07722               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CERNER FETALINK+(VERSION1.0)
CERNER CORP.                      510(k) NO: K121758(TRADITIONAL)
ATTN: SHELLEY S LOOBY             PHONE NO : 816 201 1368   
10234 MARION PARK DRIVE           SE DECISION MADE: 09-OCT-12
KANSAS CITY MO 64137              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BRIGHTGLASS BRIGHTGLASS M
KTK MEDICAL SUPPLIES GMBH         510(k) NO: K122025(TRADITIONAL)
ATTN: THOMAS  LOTTERMOSER         PHONE NO : 498 984 079721
INDUSTRIESTR. 16                  SE DECISION MADE: 09-OCT-12
GERMERING    GM D-821110          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K121076(TRADITIONAL)
ATTN: CHARLEMAGNE  CHUA           PHONE NO : 714 669 7896   
2441 MICHELLE DR.                 SE DECISION MADE: 09-OCT-12
TUSTIN CA 92781 2068              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FEMORAL HEADS, 2.5 AND 7.5 MM NECK LENGTH
UNITED ORTHOPEDIC CORPORATION     510(k) NO: K122504(SPECIAL)
ATTN: FANG-YUAN  HO               PHONE NO : 886 357 73351
NO 57, PARK AVE 2, SCIENCE PARK   SE DECISION MADE: 10-OCT-12
HSINCHU    TW 300                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BLUE SUI SLING
BOSTON SCIENTIFIC CORP.           510(k) NO: K121754(TRADITIONAL)
ATTN: JANET A MCGRATH             PHONE NO : 508 683 4726   
100 BOSTON SCIENTIFIC WAY M21     SE DECISION MADE: 10-OCT-12
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WECK REUSABLE OBTURATOR
TELEFLEX MEDICAL, INC.            510(k) NO: K121796(TRADITIONAL)
ATTN: HOLLY  KORNEGAY             PHONE NO : 919 433 4918   
2917 WECK DR.                     SE DECISION MADE: 11-OCT-12
RESEARCH TRIANGLE PARK NC 27709   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA
LOMA VISTA MEDICAL                510(k) NO: K121083(TRADITIONAL)
ATTN: TIFFINI  DIAGE              PHONE NO : 707 799 6732   
1307 SOUTH MARY AVE, STE 280      SE DECISION MADE: 11-OCT-12
SUNNYVALE CA 94087                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, BASE PLATES & HUMERAL STEMS
ZIMMER, INC.                      510(k) NO: K121543(TRADITIONAL)
ATTN: ANTHONY  FRANCALANCIA       PHONE NO : 
P.O. BOX 708                      SE DECISION MADE: 11-OCT-12
WARSAW IN 46581 0708              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM
ROCHE DIAGNOSTICS                 510(k) NO: K121679(TRADITIONAL)
ATTN: MIKE  FLIS                  PHONE NO : 317 521 2100   
9115 HAGUE ROAD                   SE DECISION MADE: 11-OCT-12
INDIANAPOLIS IN 46250             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WIRELESS THERMOMETER
RALING MEDICAL COMPANY            510(k) NO: K121696(TRADITIONAL)
ATTN: WU  WEI                     PHONE NO : 861 064 118658
NO. 11, HUATONG RD                SE DECISION MADE: 11-OCT-12
BEIJING    CH 102200              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PNEUTON MINI VENTILATOR PNEUTON MINI NON-INVASIVE VENTILATION (NIV) KIT ACCESSORY
AIRON CORPORATION                 510(k) NO: K121379(TRADITIONAL)
ATTN: G. ERIC  GJERDE             PHONE NO : 321 821 9433   
751 North Dr Ste 6                SE DECISION MADE: 11-OCT-12
Melbourne FL 32934                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERFIX FEMORAL IMPLANT W
CAYENNE MEDICAL, INC.             510(k) NO: K122463(SPECIAL)
ATTN: KERESHMEH  SHAHRIARI        PHONE NO : 480 502 3661   
16597 N. 92ND STREET SUITE 101    SE DECISION MADE: 11-OCT-12
SCOTTSDALE AZ 85260               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROFEMUR Z REVISION HIP STEM
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K122778(SPECIAL)
ATTN: DEAN  NACHTRAB              PHONE NO : 901 290 5812   
5677 AIRLINE RD.                  SE DECISION MADE: 11-OCT-12
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLAVORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (VANLLA, GRAPE AND STRAWBERRY)
TEKMEDIC (M) SDN BHD              510(k) NO: K121591(TRADITIONAL)
ATTN: PATRICK  LEONG              PHONE NO : 606 351095 9
PLOT 4, TANJUNG KLING INDUSTRIAL ASE DECISION MADE: 11-OCT-12
JETTY, TANJUNG KLING, MALACCA    M510(k) STATEMENT

DEVICE: FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 19MM X 1
OSTIAL CORPORATION                510(k) NO: K122178(TRADITIONAL)
ATTN: KAITLIN VON  HOFFMANN       PHONE NO : 650 903 9100   
510 CLYDE AVENUE                  SE DECISION MADE: 11-OCT-12
MOUNTAIN VIEW CA 94043            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARCHON ANTERIOR CERVICAL PLATE SYSTE,
NUVASIVE, INCORPORATED            510(k) NO: K122910(SPECIAL)
ATTN: CYNTHIA  ADAMS              PHONE NO : 858 320 4549   
7475 LUSK BOULEVARD               SE DECISION MADE: 11-OCT-12
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CXI SUPPORT CATHETER
COOK, INC.                        510(k) NO: K122796(SPECIAL)
ATTN: MOLLY  BUSENBARK            PHONE NO : 812 339 2235   
750 DANIELS WAY                   SE DECISION MADE: 11-OCT-12
Blmgtn IN 47404                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIFEPAK 1000 DEFIBRILLATOR
PHYSIO-CONTROL, INC.              510(k) NO: K122600(TRADITIONAL)
ATTN: MICHELLE  ACKERMANN         PHONE NO : 425 867 4744   
11811 WILLOWS RD., N.E. PO BOX 970SE DECISION MADE: 11-OCT-12
REDMOND WA 98073 9706             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAPSURE(R) PS SYSTEM
SPINE WAVE, INC.                  510(k) NO: K122233(SPECIAL)
ATTN: JOSEPH  MERCADO             PHONE NO : 203 944 9494   
THREE ENTERPRISE DR. SUITE 210    SE DECISION MADE: 11-OCT-12
SHELTON CT 06484                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELL
EXACTECH, INC.                    510(k) NO: K122798(SPECIAL)
ATTN: AMY  TAULBEE                PHONE NO : 352 377 1140   
2320 N.W. 66TH CT.                SE DECISION MADE: 11-OCT-12
GAINESVILLE FL 32653              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VISUALIF CHALLENGING ACCESS PLATE
SPINE SMITH PARTNERS L.P.         510(k) NO: K122168(SPECIAL)
ATTN: CLIFTON  NAIVAR             PHONE NO : 512 637 2068   
93 Red River                      SE DECISION MADE: 11-OCT-12
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KIT
KCI USA, INC. (KINETIC CONCEPTS, I510(k) NO: K121883(TRADITIONAL)
ATTN: SHANNON  SCOTT              PHONE NO : 210 515 4368   
6203 FARINON DRIVE                SE DECISION MADE: 11-OCT-12
SAN ANTONIO TX 78249              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ESA620 ELECTRICAL SAFETY ANALYZER
FLUKE BIOMEDICAL                  510(k) NO: K121722(TRADITIONAL)
ATTN: JOHN  NELSON                PHONE NO : 440 498 2579   
6045 COCHRAN RD.                  SE DECISION MADE: 11-OCT-12
SOLON OH 44139                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY
BECKMAN COULTER, INC              510(k) NO: K120199(TRADITIONAL)
ATTN: BEVERLY  HARDING            PHONE NO : 972 831 3656   
250 S. KRAEMER BLVD MAIL STOP A2 SSE DECISION MADE: 12-OCT-12
BREA CA 92821                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TREGOR DUAL MOBILITY ACETABULAR SYSTEM
ASTON MEDICAL                     510(k) NO: K111981(TRADITIONAL)
ATTN: CATHERINE  GLOSTER          PHONE NO : 805 679 1258   
577 NORTH HOPE AVE                SE DECISION MADE: 12-OCT-12
SANTA BARBARA CA 93110            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTI-UNIT ABUTMENTS WITH ANGULATIONS 17 AND 30 FOR TAPERED IMPLANT SYSTEM
PRISMATIK DENTALCRAFT, INC.       510(k) NO: K121688(TRADITIONAL)
ATTN: KATHLEEN  DRAGOVICH         PHONE NO : 949 399 1940   
2212 DUPONT DR., ST P             SE DECISION MADE: 12-OCT-12
IRVINE CA 92612                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RAPICIDE OPA-28 TEST STRIP
SERIM RESEARCH CORP.              510(k) NO: K120652(TRADITIONAL)
ATTN: PATRICIA  RUPCHOCK          PHONE NO : 574 264 3440   
3506 Reedy Dr                     SE DECISION MADE: 12-OCT-12
ELKHART IN 46514                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ETEST CEFTAROLINE
BIOMERIEUX, INC.                  510(k) NO: K121002(TRADITIONAL)
ATTN: JENNIFER  CHIA-HSUAN LIN    PHONE NO : 314 731 8639   
595 ANGLUM RD.                    SE DECISION MADE: 12-OCT-12
HAZELWOOD MO 63042                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ME HAIR2GO
SYNERON MEDICAL LTD.              510(k) NO: K121598(TRADITIONAL)
ATTN: JANICE M HOGAN              PHONE NO : 267 675 4611   
1835 MARKET ST, 29TH FLOOR        SE DECISION MADE: 12-OCT-12
PHILADELPHIA PA 19103             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AESPIRE 7900, AESPIRE VIEW
DATEX-OHMEDA                      510(k) NO: K122445(SPECIAL)
ATTN: JAMES  RASKOB               PHONE NO : 608 221 1551   
PO BOX 7550 3030 OHMEDA DR        SE DECISION MADE: 12-OCT-12
MADISON WI 53707                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UNISYN PLUS HIP STEM
CONSENSUS ORTHOPEDICS, INC.       510(k) NO: K120595(TRADITIONAL)
ATTN: MATTHEW M HULL              PHONE NO : 916 355 7100   
1115 WINDFIELD WAY, SUITE 100     SE DECISION MADE: 12-OCT-12
EL DORADO HILLS CA 95762          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K122398(TRADITIONAL)
ATTN: NOOR  MALKI                 PHONE NO : 781 269 3401   
2 EDGEWATER DRIVE                 SE DECISION MADE: 12-OCT-12
NORWOOD MA 02062                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANCHORSURE
NEOMEDIC INTERNATIONAL S.L.       510(k) NO: K120831(TRADITIONAL)
ATTN: JEFFREY R SHIDEMAN          PHONE NO : 952 835 4018   
7307 GLOUCHESTER DRIVE            SE DECISION MADE: 12-OCT-12
EDINA MN 55435                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE
MEDTRONIC INC.                    510(k) NO: K122811(SPECIAL)
ATTN: JACQUELINE A HAUGE          PHONE NO : 763 514 9967   
7611 NORTHLAND DRIVE              SE DECISION MADE: 12-OCT-12
MINNEAPOLIS MN 55428              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORTHOLOC 3DI MIDFOOT/FLATFOOT SYSTEM
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K121651(TRADITIONAL)
ATTN: LESLIE  FITCH               PHONE NO : 901 867 4120   
5677 AIRLINE RD.                  SE DECISION MADE: 12-OCT-12
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOMET MICROFIXATION NEURO PLATING SYSTEM
BIOMET MICROFIXATION              510(k) NO: K121624(TRADITIONAL)
ATTN: SHERYL  MALMBERG            PHONE NO : 904 741 9465   
1520 TRADEPORT DR.                SE DECISION MADE: 12-OCT-12
JACKSONVILLE FL 32218             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COCHLEAR BAHA IMPLANT SYSTEM
COCHLEAR AMERICAS                 510(k) NO: K121317(TRADITIONAL)
ATTN: SEAN  BUNDY                 PHONE NO : 800 523 5798   
13059 E PEAKVIEW AVE              SE DECISION MADE: 12-OCT-12
CENTENNIAL CO 80111               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL D3 AND D6
EDAN INSTRUMENTS, INC.            510(k) NO: K122574(TRADITIONAL)
ATTN: RANDY  JIANG                PHONE NO : 867 552 6856469
EQUIPMENTS PARK, NANHAI RD 1019 NOSE DECISION MADE: 12-OCT-12
SHENZHEN    CH 518067             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: PIONEER STERNAL CABLE PLATE SYSTEM
PIONEER SURGICAL TECHNOLOGY, INC  510(k) NO: K122293(TRADITIONAL)
ATTN: SARAH  MCINTYRE             PHONE NO : 906 225 5861   
375 RIVER PARK CIRCLE             SE DECISION MADE: 12-OCT-12
Marquette MI 49855                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IFUSE IMPLANT SYSTEM
SI-BONE, INC.                     510(k) NO: K122074(TRADITIONAL)
ATTN: CINDY  DOMECUS              PHONE NO : 650 343 4813   
3055 OLIN AVE. SUITE 2200         SE DECISION MADE: 12-OCT-12
SAN JOSE CA 95128                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLS
ADVANCED STERILIZATION PRODUCTS   510(k) NO: K112087(TRADITIONAL)
ATTN: NANCY  CHU                  PHONE NO : 949 453 6435   
33 TECHNOLOGY DR.                 SE DECISION MADE: 15-OCT-12
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FINGERTIP PULSE OXIMETER
ANDON HEALTH CO., LTD             510(k) NO: K121697(TRADITIONAL)
ATTN: LIU  YI                     PHONE NO : 86 22 60526161
No. 3 Jin Ping Street,Ya An Road, SE DECISION MADE: 15-OCT-12
TIANJIN    CN 300190              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUTOJECT 2 FOR GLASSY SYRINGE
OWEN MUMFORD, LTD.                510(k) NO: K122837(SPECIAL)
ATTN: DARREN  MANSELL             PHONE NO : 044 19 93812021
BROOK HILL                        SE DECISION MADE: 15-OCT-12
WOODSTOCK, OXFORDSHIRE    UK 0X20I510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMITH & NEPHEW REDAPT REVISION FEMORAL SYSTEM
SMITH & NEPHEW, INC.              510(k) NO: K121627(ABBREVIATED)
ATTN: NATALIE P WILLIAMS          PHONE NO : 901 399 5161   
7135 GOODLETT FARMS PARKWAY       SE DECISION MADE: 15-OCT-12
CORDOVA TN 38016                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROTECH DENT
AKERVALL TECHNOLOGIES INC         510(k) NO: K121272(TRADITIONAL)
ATTN: SASSA  AKERVALL             PHONE NO : 800 444 0570   
5520 STONE VALLEY DRIVE           SE DECISION MADE: 15-OCT-12
ANN ARBOR MI 48105                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GRAM POSTITVE CLINDAMYCIN
BIOMERIEUX, INC.                  510(k) NO: K122547(TRADITIONAL)
ATTN: ELIZABETH  LANDON           PHONE NO : 919 620 2329   
595 ANGLUM RD.                    SE DECISION MADE: 15-OCT-12
HAZELWOOD MO 63042                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REUSABLE CUTANEOUS ELECTRODE
AMPCARE, LLC                      510(k) NO: K121483(TRADITIONAL)
ATTN: DIANE  RUTHERFORD           PHONE NO : 972 480 9554   
1201 RICHARDSON DRIVE SUITE 280   SE DECISION MADE: 15-OCT-12
RICHARDSON TX 75080               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 14MM ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 16MM
MEDICAL DESIGN LLC.               510(k) NO: K122497(TRADITIONAL)
ATTN: KRISTI  VONDRA              PHONE NO : 605 275 1032   
6709 S. MINNESOTA AVE. STE 204    SE DECISION MADE: 15-OCT-12
SIOUX FALLS SD 57108 2593         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE)
ABBOTT MEDICAL OPTICS INC         510(k) NO: K121721(TRADITIONAL)
ATTN: ABBAS M BOHRA               PHONE NO : 714 247 8488   
1700 E. ST. ANDREW PLACE          SE DECISION MADE: 15-OCT-12
SANTA ANA CA 92705                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUARTZ SPLINT SYSTEM (UD, WOVEN, ROPE, MESH) QUARTZ SPINT RESIN QS FLOW
RECHERCHES TECHNIQUES DENTAIRES (R510(k) NO: K122348(TRADITIONAL)
ATTN: MANH-QUYNH  CHU             PHONE NO : 330 476 565666
3 RUE LOUIS NEEL                  SE DECISION MADE: 15-OCT-12
ST. EGREVE    FR 38120            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAVITY VARNISH
DENTSPLY INTERNATIONAL, INC.      510(k) NO: K122331(TRADITIONAL)
ATTN: HELEN  LEWIS                PHONE NO : 717 849 4229   
221 W. PHILADELPHIA ST., SE 60    SE DECISION MADE: 15-OCT-12
YORK PA 17404                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AESKUSLIDES ANA HEP-2
AESKU.DIAGNOSTICS                 510(k) NO: K120889(TRADITIONAL)
ATTN: HELENE  PAXTON              PHONE NO : 443 253 4135   
87 PEDRICKTOWN-WOODSTOWN RD       SE DECISION MADE: 15-OCT-12
PEDRICKTOWN NJ 08067              510(k) STATEMENT

DEVICE: DISPOSABLE SURGICAL GOWNS
WEIHAI HONGYU NONWOVEN FABRIC PROD510(k) NO: K120192(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 862 122 815850
P.O. BOX 237-023                  SE DECISION MADE: 16-OCT-12
WEIHAI    CN 200030               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ME AGAIN(R) LONG LASTING VAGINAL MOISTURIZER, VH ESSENTIALS (R) LONG LASTING VAGINAL MOISTURIZER
POLICHEM S.A.                     510(k) NO: K112217(TRADITIONAL)
ATTN: JOHN  NYGAARD               PHONE NO : 262 677 4121   
1 PHARMACAL WAY                   SE DECISION MADE: 16-OCT-12
JACKSON WI 53037                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMS LARGE PORE POLYPROPHLENE MESH
AMERICAN MEDICAL SYSTEMS          510(k) NO: K121805(TRADITIONAL)
ATTN: RENEE  MELLUM               PHONE NO : 952 939 6458   
10700 BREN ROAD WEST              SE DECISION MADE: 16-OCT-12
MINNETONKA MN 55343               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMITH & NEPHEW R3 CONSTRAINED LINERS
SMITH & NEPHEW, INC.              510(k) NO: K122139(TRADITIONAL)
ATTN: MARTIN  OSTMANN             PHONE NO : 901 399 1809   
1450 BROOKS RD.                   SE DECISION MADE: 16-OCT-12
MEMPHIS TN 38116                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, PINK
INDUSTRIAL CLOTHINGS, LTD.        510(k) NO: K122465(TRADITIONAL)
ATTN: S.N.  HARI                  PHONE NO : 943 654 22200
D 17, SEETHAWAKA EXPORT PROCESSINGSE DECISION MADE: 16-OCT-12
AUISSAWELLA    CE 10700           510(k) STATEMENT

DEVICE: ACCUMESH DEPLOYMENT SYSTEM
COVIDIEN LLC                      510(k) NO: K123066(SPECIAL)
ATTN: ELIZABETH  MCMENIMAN        PHONE NO : 781 839 1785   
15 CROSBY DRIVE                   SE DECISION MADE: 16-OCT-12
BEDFORD MA 01730                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR
XINWEI (SHANDONG) PLASTIC AND RUBB510(k) NO: K121992(TRADITIONAL)
ATTN: FRANK  LIU                  PHONE NO : 909 548 4828   
12390 EAST END AVE.               SE DECISION MADE: 16-OCT-12
CHINO CA 91710                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006
OLYMPUS MEDICAL SYSTEMS CORP.     510(k) NO: K121564(TRADITIONAL)
ATTN: LAURA  STORMS-TYLER         PHONE NO : 484 896 5688   
3500 CORPORATE PARKWAY P.O. BOX 61SE DECISION MADE: 16-OCT-12
CENTER VALLEY PA 18034 0610       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TOWERLOX PEDICLE SCREW SYSTEM
CAPTIVA SPINE                     510(k) NO: K122332(SPECIAL)
ATTN: RICH  JANSEN                PHONE NO : 612 281 5505   
13540 GUILD AVE                   SE DECISION MADE: 16-OCT-12
APPLE VALLY MN 55124              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NIPRO SAFE TOUCH HUBER INFUSION SET
NIPRO MEDICAL CORPORATION         510(k) NO: K113470(TRADITIONAL)
ATTN: JESSICA  OSWALD             PHONE NO : 305 599 7174   
3150 N.W. 107TH AVE.              SE DECISION MADE: 17-OCT-12
MIAMI FL 33172                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STINGRAY CERVICAL CAGE
OMNI SURGICAL, LP DBA SPINE360    510(k) NO: K122085(ABBREVIATED)
ATTN: DAVE  LAMB                  PHONE NO : 512 327 6400   
5000 Plaza on the Lake, Suite 305 SE DECISION MADE: 17-OCT-12
Austin TX 78746                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE NITRILE EXAMINATION GLOVE-BLUE (CHEMOTHERAPY)
MATANG MFG. SDN. BHD.             510(k) NO: K122131(TRADITIONAL)
ATTN: LESLIE  LEONG               PHONE NO : 606 263 3129
LOT 10, KAWASAN PERINDUSTRIAN SERKSE DECISION MADE: 17-OCT-12
MERLIMAU, MELAKA    MY 77300      510(k) STATEMENT

DEVICE: GLOBAL MEDI PRODUCTS RETRACTABLE SAFETY SYRINGE
GLOBAL MEDI PRODUCTS              510(k) NO: K120641(TRADITIONAL)
ATTN: ROBERT O DEAN               PHONE NO : 716 440 7362   
1083 DELWARE AVE.                 SE DECISION MADE: 17-OCT-12
BUFFALO NY 14209                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THS INSTRUMENT TRAY
HOLOGIC, INC.                     510(k) NO: K120947(TRADITIONAL)
ATTN: SARAH  FAIRFIELD            PHONE NO : 508 263 8857   
250 CAMPUS DRIVE                  SE DECISION MADE: 17-OCT-12
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CHARTER GUIDEWIRE
BRIVANT, LTD.                     510(k) NO: K122856(SPECIAL)
ATTN: KENNETH  WALSH              PHONE NO : 353 913 85037
PARKMORE WEST BUSINESS PARK       SE DECISION MADE: 17-OCT-12
GALWAY    EI EI                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY PLUS CONTROL, LEVEL 2 MODEL 268, LIQUICHEK
BIO-RAD LABORATORIES              510(k) NO: K122838(TRADITIONAL)
ATTN: SUZANNE  PARSONS            PHONE NO : 949 598 1467   
9500 JERONIMO RD.                 SE DECISION MADE: 17-OCT-12
IRVINE CA 92618 2017              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INSPIRE 8F DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL RESERVOIR
SORIN GROUP ITALIA S.R.L.         510(k) NO: K122844(SPECIAL)
ATTN: SCOTT  LIGHT                PHONE NO : 303 467 6313   
14401 W. 65TH WAY                 SE DECISION MADE: 17-OCT-12
ARVADA CO 80004                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NU SLEEP
RH ASSOCIATES LLC                 510(k) NO: K121344(ABBREVIATED)
ATTN: DANIELA  LEVY               PHONE NO : 213 447 5297   
22817 VENTURA BLVD #161           SE DECISION MADE: 17-OCT-12
WOODLAND HILLS CA 91364           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BOX PEEK VBR SYSTEM,
INNOVASIS, INC.                   510(k) NO: K121581(TRADITIONAL)
ATTN: MARSHALL C MCCARTY          PHONE NO : 801 261 2236   
614 EAST 3900 SOUTH               SE DECISION MADE: 17-OCT-12
SALT LAKE CITY UT 84107           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QBTES
QBTECH AB                         510(k) NO: K122149(TRADITIONAL)
ATTN: HANS  BOSTROM               PHONE NO : 46 70 6339209
Kungsgatan 29                     SE DECISION MADE: 17-OCT-12
Stockholm    SE 11156             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOWRIST STAPLER SYSTEM
INTUITIVE SURGICAL, INC.          510(k) NO: K113706(TRADITIONAL)
ATTN: MEGHNA  SRIDHARAN           PHONE NO : 408 523 2487   
1266 Kifer Rd                     SE DECISION MADE: 17-OCT-12
Sunnyvale CA 94086                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IPS E.MAX PRESS - ABUTMENT SOLUTIONS
IVOCLAR VIVADENT AG               510(k) NO: K120053(TRADITIONAL)
ATTN: DONNA MARIE  HARTNETT       PHONE NO : 716 691 2260   
175 PINEVIEW DR.                  SE DECISION MADE: 18-OCT-12
AMHERST NY 14228                  510(k) STATEMENT

DEVICE: STERILE BLUNT FOR SINGLE USE
SHANGHAI DOUBLE DOVE INDUSTRIAL CO510(k) NO: K120420(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 862 122 815850
P.O. BOX 237-023                  SE DECISION MADE: 18-OCT-12
SHANGHAI    CH 200237             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE
NIPRO MEDICAL CORPORATION         510(k) NO: K113469(TRADITIONAL)
ATTN: JESSICA  OSWALD             PHONE NO : 305 599 7174   
3150 N.W. 107TH AVE.              SE DECISION MADE: 18-OCT-12
MIAMI FL 33172                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SET
NIPRO MEDICAL CORPORATION         510(k) NO: K113471(TRADITIONAL)
ATTN: JESSICA  OSWALD             PHONE NO : 305 599 7174   
3150 N.W. 107TH AVE.              SE DECISION MADE: 18-OCT-12
MIAMI FL 33172                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COUGAR LS 15 LATERAL CAGE SYSTEM
MEDOS INTERNATIONAL SARL          510(k) NO: K122896(SPECIAL)
ATTN: KIRSTEN  LEHMULLER          PHONE NO : 508 828 3291   
325 PARAMOUNT DRIVE               SE DECISION MADE: 18-OCT-12
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMITH & NEPHEW ULTRA FAST-FIX MENISCAL REPAIR SYSTEM, SMITH & NEPHEW ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEM, SMITH & N
SMITH & NEPHEW, INC.              510(k) NO: K121861(TRADITIONAL)
ATTN: KARIN  DESJARDINS           PHONE NO : 508 337 4035   
150 MINUTEMAN RD.                 SE DECISION MADE: 18-OCT-12
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NMI HPICC III
NAVILYST MEDICAL, INC.            510(k) NO: K122882(SPECIAL)
ATTN: WANDA  CARPINELLA           PHONE NO : 508 658 7945   
26 FOREST STREET                  SE DECISION MADE: 18-OCT-12
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 4-WEB CERVICAL STS (SPINAL TRUSS SYSTEM)
4-WEB, INC.                       510(k) NO: K121741(TRADITIONAL)
ATTN: RICH  JANSEN, PHARM, D.     PHONE NO : 612 281 5505   
13540 GUILD AVE.                  SE DECISION MADE: 18-OCT-12
APPLE VALLEY MN 55124             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DOMAIN SURGICAL SYSTEM
DOMAIN SURGICAL, INC.             510(k) NO: K121881(TRADITIONAL)
ATTN: CURTIS  JENSEN              PHONE NO : 801 924 4958   
1370 SOUTH 2100 EAST              SE DECISION MADE: 18-OCT-12
SALT LAKE SITY UT 84108           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEE
CAREFUSION                        510(k) NO: K121849(TRADITIONAL)
ATTN: JOY  GREIDANUS              PHONE NO : 847 473 7404   
1500 WAUKEGAN ROAD                SE DECISION MADE: 18-OCT-12
MCGAW PARK IL 60085               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIRCAST VENAFLOW ELITE SYSTEM
DJO, LLC                          510(k) NO: K122499(TRADITIONAL)
ATTN: KEN  FISHER                 PHONE NO : 760 734 5599   
1430 DECISION STREET              SE DECISION MADE: 18-OCT-12
VISTA CA 92081 8553               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYSMEX XN-SERIES
SYSMEX AMERICA, INC.              510(k) NO: K112605(TRADITIONAL)
ATTN: SHARITA  BROOKS             PHONE NO : 847 996 1648   
577 Aptakisic Rd                  SE DECISION MADE: 19-OCT-12
Lincolnshire IL 60069             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
ELLIPSE TECHNOLOGIES, INC.        510(k) NO: K113219(TRADITIONAL)
ATTN: JOHN  MCLNTYRE              PHONE NO : 949 837 3600   
13900 Alton Pkwy Ste 123          SE DECISION MADE: 19-OCT-12
Irvine CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VENUS FACET SCREW SYSTEM
APOLLO SPINE, INC.                510(k) NO: K120340(TRADITIONAL)
ATTN: CHRISTINE  SANTAGATE        PHONE NO : 781 828 4400   
75 MILL STREET                    SE DECISION MADE: 19-OCT-12
STOUGHTON MA 02072                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XN CHECK
STRECK                            510(k) NO: K120742(TRADITIONAL)
ATTN: DEBORAH S KIPP              PHONE NO : 402 537 5215   
7002 SOUTH 109TH ST.              SE DECISION MADE: 19-OCT-12
OMAHA NE 68128                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XN CHECK BF
STRECK                            510(k) NO: K120744(TRADITIONAL)
ATTN: DEBORAH S KIPP              PHONE NO : 402 537 5215   
7002 SOUTH 109TH ST.              SE DECISION MADE: 19-OCT-12
OMAHA NE 68128                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XN CAL
STRECK                            510(k) NO: K120745(TRADITIONAL)
ATTN: DEBORAH S KIPP              PHONE NO : 402 537 5215   
7002 SOUTH 109TH ST.              SE DECISION MADE: 19-OCT-12
OMAHA NE 68128                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL FLAT PLANEL X-RAY DETECTOR / 1717SCC
RAYENCE CO., LTD                  510(k) NO: K122173(SPECIAL)
ATTN: DAVE  KIM                   PHONE NO : 713 467 2607   
12946 KIMBERLEY LN                SE DECISION MADE: 19-OCT-12
HOUSTON TX 77079                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM
MEDRAD, INC.                      510(k) NO: K122916(SPECIAL)
ATTN: BRIT  BAIRD                 PHONE NO : 425 636 4137   
10801 120TH AVENUE NE             SE DECISION MADE: 19-OCT-12
KIRKLAND WA 98033                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AFFINITY FUSION RECIRCULATION LINE MODEL RCL841
MEDTRONIC INC.                    510(k) NO: K122913(TRADITIONAL)
ATTN: MARY E DONLIN               PHONE NO : 763 526 9172   
7611 NORTHLAND DRIVE              SE DECISION MADE: 19-OCT-12
BROOKLYN PARK MN 55428            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERSAFITCUP CC TRIO EXTENSION
MEDACTA INTERNATIONAL             510(k) NO: K122911(SPECIAL)
ATTN: ADAM  GROSS                 PHONE NO : 805 437 7085   
4725 CALLE QUETZAL, UNIT B        SE DECISION MADE: 19-OCT-12
CAMARILLO CA 93012                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LACRICATH LACRIMAL DUCT CATHETER
QUEST MEDICAL, INC.               510(k) NO: K113867(TRADITIONAL)
ATTN: AMY  CLENDENING-WHEELER     PHONE NO : 972 332 6338   
ONE ALLENTOWN PKWY.               SE DECISION MADE: 19-OCT-12
ALLEN TX 75002                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 3M ATTEST(TM) SUPER RAPID READOUT BIOLOGICAL INDICATOR, 3M ATTEST(TM) AUTO-READER
3M COMPANY                        510(k) NO: K121484(TRADITIONAL)
ATTN: SUZANNE  LEUNG              PHONE NO : 651 575 8052   
3M CENTER, BLDG. 275-5W-06        SE DECISION MADE: 19-OCT-12
ST. PAUL MN 55144 1000            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NONDISPOSABLE STIMULATING INSTRUMENTS
NEUROVISION MEDICAL PRODUCTS, INC.510(k) NO: K121931(TRADITIONAL)
ATTN: CHRISTINE  VERGELY          PHONE NO : 805 866 6999   
2225 SPERRY AVE, SUITE 1000       SE DECISION MADE: 19-OCT-12
VENTURA CA 93003                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SDX SYSTEM
DYN'R SAS                         510(k) NO: K121845(TRADITIONAL)
ATTN: TIM  LAWTON                 PHONE NO : 334 422 10734
74 COURS GAMBETTA                 SE DECISION MADE: 19-OCT-12
AIX EN PROVENCE    FR 13100       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRACTICAL COMPRESSION DEVICE (PCD) 901A&901B
MEGO AFEK AC LTD                  510(k) NO: K121962(TRADITIONAL)
ATTN: ALEX  RAPEL                 PHONE NO : 972 779 084276
KIBBUTZ AFEK                      SE DECISION MADE: 19-OCT-12
AFEK    IS 30042                  510(k) STATEMENT

DEVICE: SMITH & NEPHEW, INC. INTRAMEDULLARY NAIL SYSTEM INSTRUMENTATION
SMITH & NEPHEW, INC.              510(k) NO: K122170(TRADITIONAL)
ATTN: BRADLEY  HEIL               PHONE NO : 901 399 6339   
7135 GOODLETT FARMS PARKWAY       SE DECISION MADE: 19-OCT-12
CORDOVA TN 38016                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZIRPRIME
KURARAY NORITAKE DENTAL INC.      510(k) NO: K121980(TRADITIONAL)
ATTN: IVAN  WASSERMAN             PHONE NO : 202 585 6529   
700 12TH ST SW SUITE 100          SE DECISION MADE: 19-OCT-12
WASHINGTON DC 20005               510(k) STATEMENT

DEVICE: ZFX DENTAL CAD SYSTEM
ZIMMER DENTAL INC.                510(k) NO: K121709(TRADITIONAL)
ATTN: CECILIA  SILVA              PHONE NO : 760 929 4300   
1900 ASTON AVE.                   SE DECISION MADE: 19-OCT-12
CARLSBAD CA 92008 7308            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERTECEM II CEMENT KIT
AAP BIOMATERIALS GMBH             510(k) NO: K121876(ABBREVIATED)
ATTN: VOLKER  STIRNAL             PHONE NO : 496 071 929220
LAGERSTRASSE 11-15                SE DECISION MADE: 19-OCT-12
DIEBURG    GM D-64807             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRANSTEK WRIST BLOOD PRESSURE MONITOR
ZHONGSHAN TRANSTEK ELECTRONICS CO.510(k) NO: K122482(ABBREVIATED)
ATTN: LEO  WANG                   PHONE NO : 086 288 6083300
NO. 1 FANGHUA STREET HI-TECH ZONE SE DECISION MADE: 22-OCT-12
CHENGDU    CH 610041              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XN CAL PF
STRECK                            510(k) NO: K120747(TRADITIONAL)
ATTN: DEBORAH S KIPP              PHONE NO : 402 537 5215   
7002 SOUTH 109TH ST.              SE DECISION MADE: 22-OCT-12
OMAHA NE 68128                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CPRMETER CPR FEEDBACK DEVICE
LAERDAL MEDICAL A/S               510(k) NO: K122050(TRADITIONAL)
ATTN: DAN  DILLION                PHONE NO : 765 763 7537   
1 GEDDES WAY                      SE DECISION MADE: 22-OCT-12
WEST LAFAYETTE IN 47906           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ATLAS GOLD PTA DILATATION CATHETER
C.R. BARD, INC.                   510(k) NO: K122984(TRADITIONAL)
ATTN: JENNIFER  LOGVIN            PHONE NO : 480 303 2752   
1625 WEST 3RD ST.                 SE DECISION MADE: 22-OCT-12
TEMPE AZ 85281 1740               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEM
BIOMET MANUFACTURING CORP.        510(k) NO: K122277(TRADITIONAL)
ATTN: ELIZABETH  WRAY             PHONE NO : 800 348 9500   
56 EAST BELL DRIVE P.O. BOX 587   SE DECISION MADE: 22-OCT-12
WARSAW IN 46581 0587              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DYNASTY BIOFOAM SHELL
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K122382(SPECIAL)
ATTN: DEAN  NACHTRAB              PHONE NO : 901 290 5812   
5677 AIRLINE RD.                  SE DECISION MADE: 22-OCT-12
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PHASIX PLUG AND PATCH
C.R. BARD INC                     510(k) NO: K120728(TRADITIONAL)
ATTN: SHERMA  WINSTON             PHONE NO : 401 825 8737   
100 CROSSINGS BOULEVARD           SE DECISION MADE: 22-OCT-12
WARWICK RI 02886                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
SURGICAL SPECIALTIES CORP. DBA ANG510(k) NO: K122898(TRADITIONAL)
ATTN: KIRSTEN  STOWELL            PHONE NO : 610 404 3367   
100 DENNIS DR.                    SE DECISION MADE: 22-OCT-12
Reading PA 19606                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LONGEVITY IT HIGHLY CROSSLINKED POLYETHYENE LINERS
ZIMMER, INC.                      510(k) NO: K123019(SPECIAL)
ATTN: REBECCA  BROOKS             PHONE NO : 574 371 8033   
1800 WEST CENTER STREET           SE DECISION MADE: 22-OCT-12
WARSAW IN 46580                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDRANGE ELECTROSURGICAL EXPANSION SYSTEM
MEDRANGE CORPORATION              510(k) NO: K122092(TRADITIONAL)
ATTN: KUOFANG  HUANG              PHONE NO : 714 784 5202   
480 Apollo St Ste D               SE DECISION MADE: 23-OCT-12
Brea CA 92821                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RESOLUTE FACET SCREW SYSTEM
NEUROSTRUCTURES, LLC              510(k) NO: K121551(TRADITIONAL)
ATTN: MEREDITH  MAY               PHONE NO : 719 337 7579   
4628 NORTHPARK DR                 SE DECISION MADE: 23-OCT-12
COLORADO SPRINGS CO 80918         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HX-461
SEERS TECHNOLOGY CO, LTD          510(k) NO: K120545(TRADITIONAL)
ATTN: PETER  CHUNG                PHONE NO : 412 687 3976   
300 ATWOOD                        SE DECISION MADE: 23-OCT-12
PITTSBURGH PA 15213               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AURICAL HIT
GN OTOMETRICS                     510(k) NO: K122028(TRADITIONAL)
ATTN: DANIEL  KAMM                PHONE NO : 239 234 1735   
8870 RAVELLO CT                   SE DECISION MADE: 23-OCT-12
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IPULSE SMOOTHSKIN HAIR REMOVAL SYSTEM
CYDEN LIMITED                     510(k) NO: K122280(TRADITIONAL)
ATTN: AUSTIN  SPEIER              PHONE NO : 202 822 1850   
2001 PENNSYLANIA AVE SUITE 950    SE DECISION MADE: 23-OCT-12
WASHINGTON DC 20006               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROTON RADIATION THERAPY BEAM-SHAPING APERTURE PROTON RADIAION THERAPY BEAM-SHPING RANGE COMPENSATOR
PROTON SYSTEMS                    510(k) NO: K121657(TRADITIONAL)
ATTN: MIKE  BEGALA                PHONE NO : 512 327 9997   
611 WEST 5TH STREET THIRD FLOOR   SE DECISION MADE: 23-OCT-12
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FORTEX PEDICLE SCREW SYSTEM
X-SPINE SYSTEMS, INC              510(k) NO: K120832(SPECIAL)
ATTN: DAVID  KIRSCHMAN            PHONE NO : 937 847 8400   
452 Alexandersville Rd            SE DECISION MADE: 23-OCT-12
Miamisburg OH 45342               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NUVASIVE SAGE LATERAL PLATE SYSTEM
NUVASIVE, INC.                    510(k) NO: K121815(TRADITIONAL)
ATTN: SHEILA  BRUSCHI             PHONE NO : 858 320 4515   
7475 LUSK BLVD                    SE DECISION MADE: 23-OCT-12
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GEO
RESMED LTD.                       510(k) NO: K121705(SPECIAL)
ATTN: JIM  CASSI                  PHONE NO : 858 836 6081   
9001 SPECTRUM CENTER BLVD.        SE DECISION MADE: 23-OCT-12
SAN DIEGO CA 92123                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARESTREAM VUE PACS
CARESTREAM HEALTH, INC.           510(k) NO: K122523(TRADITIONAL)
ATTN: ALEXANDRA  CHAMBERLAIN      PHONE NO : 585 627 8790   
150 VERONA STREET                 SE DECISION MADE: 23-OCT-12
ROCHESTER NY 14608                510(k) STATEMENT

DEVICE: ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE
COVIDIEN                          510(k) NO: K123109(SPECIAL)
ATTN: RENEE  BORGESANO            PHONE NO : 203 492 5325   
60 MIDDLETOWN AVE.                SE DECISION MADE: 23-OCT-12
NORTH HAVEN CT 06473              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OSSEOFLEX SB INFLATABLE BONE TAMP
OSSEON THERAPEUTICS, INC.         510(k) NO: K122533(TRADITIONAL)
ATTN: KEITH  BURGER               PHONE NO : 707 636 5940   
2330 Circadian Way                SE DECISION MADE: 23-OCT-12
Santa Rosa CA 95407               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CDC ZIRCONIA BLANKS
CONTINENTAL DENTAL CERAMICS, INC. 510(k) NO: K122972(TRADITIONAL)
ATTN: JERRY  DOVIACK, CDT         PHONE NO : 310 618 8821   
1873 WESTERN WAY                  SE DECISION MADE: 24-OCT-12
TORRANCE CA 90501                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCER
CAREFUSION                        510(k) NO: K122422(TRADITIONAL)
ATTN: JOY  GREIDANUS              PHONE NO : 847 473 7404   
1500 WAUKEGAN ROAD                SE DECISION MADE: 24-OCT-12
MCGAW PARK \ IL 60085             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOMET LATERAL SPACER SYSTEM
BIOMET SPINE (AKA EBI, LLC)       510(k) NO: K122989(TRADITIONAL)
ATTN: MARGARET F CROWE            PHONE NO : 973 299 9300   
100 INTERPACE PARKWAY             SE DECISION MADE: 24-OCT-12
PARSIPPANY NJ 07054               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HOFFMANN 3
STRYKER CORP.                     510(k) NO: K122284(TRADITIONAL)
ATTN: ESTELA  CELI                PHONE NO : 201 831 6461   
325 CORPORATE DRIVE               SE DECISION MADE: 24-OCT-12
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMAGE-COM 5.0
TOM TEC IMAGING SYSTEMS GMBH      510(k) NO: K122289(TRADITIONAL)
ATTN: BERNHARD  MUMM              PHONE NO : 498 932 175605
EDISONSTR. 6                      SE DECISION MADE: 24-OCT-12
UNTERSCHLEISSHEIM    GM 85716     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTRAMEDULLARY NAIL SYSTEM
WEIGAO ORTHOPAEDIC DEVICE CO., LTD510(k) NO: K121312(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 862 122 815850
PO BOX 237-023                    SE DECISION MADE: 24-OCT-12
SHANGHAI    CH 200237             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SHAPEMATCH CUTTING GUIDE
STRYKER CORP.                     510(k) NO: K122053(TRADITIONAL)
ATTN: TAMMY  WHARTON              PHONE NO : 510 995 4462   
1600 HARBOR BAY DRIVE SUITE 200   SE DECISION MADE: 24-OCT-12
ALAMEDA CA 94502                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMAGEN3D
CARDIOVASCULAR IMAGING TECHNOLOGIE510(k) NO: K122241(TRADITIONAL)
ATTN: MELANIE  HASEK              PHONE NO : 913 410 2357   
9755 RIDGE DRIVE                  SE DECISION MADE: 24-OCT-12
LENEXA KS 66219                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CRE FIXED WIRE BALLON DILATION CATHETER
BOSTON SCIENTIFIC CORP.           510(k) NO: K122924(SPECIAL)
ATTN: JANIS F TARANTO             PHONE NO : 508 683 4560   
100 BOSTON SCIENTIFIC WAY         SE DECISION MADE: 24-OCT-12
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITROS CHEMISTRY PRODUCTS ECO2 SLIDES
ORTHO-CLINICAL DIAGNOSTICS, INC.  510(k) NO: K120765(SPECIAL)
ATTN: GAOZHEN  HANG               PHONE NO : 585 453 3962   
100 INDIGO CREEK DR.              SE DECISION MADE: 24-OCT-12
ROCHESTER NY 14626 5101           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZENITH, FEMORAL STEM ZENITH, DISTAL CENTRALIZER FOMORAL HEAD ACETABULAR INSERT
TGM MEDICAL, INC.                 510(k) NO: K121636(TRADITIONAL)
ATTN: PRAKASH  PAI                PHONE NO : 916 358 8835   
5145 Golden Foothill Parkway SUITESE DECISION MADE: 24-OCT-12
El Dorado Hills CA 95762          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RELIANCE POSTERIOR CERVICAL- THORACIC SYSTEM
RELIANCE MEDICAL SYSTEMS, LLC     510(k) NO: K122292(TRADITIONAL)
ATTN: BRET M BERRY                PHONE NO : 801 295 3280   
545 WEST 500 SOUTH SUITE 100      SE DECISION MADE: 24-OCT-12
BOUNTIFUL UT 84010                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMITH & NEPHEW SMF HIP STEM
SMITH & NEPHEW, INC.              510(k) NO: K123012(SPECIAL)
ATTN: NATALIE P WILLIAMS          PHONE NO : 901 339 5161   
1450 BROOKS RD.                   SE DECISION MADE: 24-OCT-12
MEMPHIS TN 38116                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS
IMMCO DIAGNOSTICS, INC.           510(k) NO: K113020(TRADITIONAL)
ATTN: KEVIN J LAWSON              PHONE NO : 716 691 0091   
60 PINEVIEW DR.                   SE DECISION MADE: 25-OCT-12
BUFFALO NY 14228 2120             510(k) STATEMENT

DEVICE: CLICKFINE PEN NEEDLE
P/L BIOMEDICAL                    510(k) NO: K122969(SPECIAL)
ATTN: LEE  LEICHTER               PHONE NO : 239 244 1448   
10882 STONIGTON AVE               SE DECISION MADE: 25-OCT-12
FORT MYERS FL 33913               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLICKFINE PEN NEEDLE
P/L BIOMEDICAL                    510(k) NO: K122971(SPECIAL)
ATTN: LEE  LEICHTER               PHONE NO : 239 244 1448   
10882 STONIGTON AVE               SE DECISION MADE: 25-OCT-12
FORT MYERS FL 33913               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANCHOR-L LUMBAR CAGE
STRYKER SPINE                     510(k) NO: K120869(TRADITIONAL)
ATTN: TIFFANI  ROGERS             PHONE NO : 201 760 8206   
2 PEARL COURT                     SE DECISION MADE: 25-OCT-12
ALLENDALE NJ 07401                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IRMA C02 MODEL 200101; IRMA AX 200601
PHASEIN AB                        510(k) NO: K123043(SPECIAL)
ATTN: DAVID  WEISSBURG            PHONE NO : 608 770 0223   
404 WILLIAMSON ST. SUITE 402      SE DECISION MADE: 25-OCT-12
MADISON WI 53703                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GE 8CH FOOT ANKLE COIL
GE HANGWEI MEDICAL SYSTEMS CO., LT510(k) NO: K122694(TRADITIONAL)
ATTN: GLEN  SABIN                 PHONE NO : 262 521 6848   
3200 N GRANDVIEW BLVD MAIL CODE-W-SE DECISION MADE: 25-OCT-12
WAUKESHA WI 53188                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STEALTH 360 ORBITAL PAD SYSTEM
CARDIOVASCULAR SYSTEMS, INC.      510(k) NO: K122987(SPECIAL)
ATTN: MAUREEN  MCDONNELL          PHONE NO : 651 259 1644   
651 CAMPUS DR.                    SE DECISION MADE: 25-OCT-12
ST. PAUL MN 55112                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OMNI 3 OXYGEN SYSTEM
CAIRE, INC.                       510(k) NO: K120785(SPECIAL)
ATTN: BRIAN  JARRELL              PHONE NO : 858 202 3157   
12230 WORLD TRADE DRIVE, SUITE 100SE DECISION MADE: 25-OCT-12
SAN DIEGO CA 92128                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COLORED POWDER FREE LATEX EXAMINATION GLOVE (WHITE AND BLUE)
TEKMEDIC (M) SDN BHD              510(k) NO: K121594(TRADITIONAL)
ATTN: PATRICK  LEONG              PHONE NO : 606 351095 9
PLOT 4, TANJUNG KLING INDUSTRIAL ASE DECISION MADE: 25-OCT-12
JETTY, TANJUNG KLING, MALACCA    M510(k) STATEMENT

DEVICE: FUSELOX LUMBAR INTERBODY FUSION DEVICE
CAPTIVA SPINE                     510(k) NO: K122956(SPECIAL)
ATTN: RICH  JANSEN                PHONE NO : 612 281 5505   
13540 GUILD AVE                   SE DECISION MADE: 25-OCT-12
APPLE VALLY MN 55124              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTUITIVE SURGICAL ONSITE FOR DA VINCI SURGICAL SYSTEMS
INTUITIVE SURGICAL, INC.          510(k) NO: K121921(TRADITIONAL)
ATTN: CHERECE L JONES             PHONE NO : 408 523 6925   
1266 KIFER ROAD                   SE DECISION MADE: 25-OCT-12
SUNNYVALE CA 94086 5206           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENSEAL TRIO TISSUE SEALING DEVICE
ETHICON ENDO-SURGERY, LLC         510(k) NO: K123141(SPECIAL)
ATTN: EMILY  KREUTZKAMP           PHONE NO : 513 337 1546   
4545 CREEK ROAD                   SE DECISION MADE: 25-OCT-12
CINCINNATI OH 45242               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUTO-DISABLE STERILE SAFTY SYRING FOR SINGLE USE
SUNWELL BIOTECH CO., LTD          510(k) NO: K121637(TRADITIONAL)
ATTN: CHARLIE  MACK               PHONE NO : 931 625 4938   
77325 JOYCE WAY                   SE DECISION MADE: 25-OCT-12
ECHO OR 97826                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR GRASPER WAVY RATCHETED, SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR
TRANSENTERIX, INC.                510(k) NO: K122299(TRADITIONAL)
ATTN: TAMMY B CARREA              PHONE NO : 919 765 8420   
635 DAVIS DRIVE SUITE 300         SE DECISION MADE: 25-OCT-12
DURHAM NC 27713                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEM
HAEMONETICS CORP.                 510(k) NO: K122262(TRADITIONAL)
ATTN: ERICA  DIAZ                 PHONE NO : 781 356 9798   
400 Wood Rd                       SE DECISION MADE: 25-OCT-12
BRAINTREE MA 02184                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL ELECTROCARDIOGRAPH
SHENZHEN BIOCARE ELECTRONICS CO., 510(k) NO: K122712(SPECIAL)
ATTN: DIANA  HONG                 PHONE NO : 86 212 2815850
P.O. BOX 237-023                  SE DECISION MADE: 25-OCT-12
SHANGHAI    CH 200237             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCT
HEIDELBERG ENGINEERING GMBH       510(k) NO: K121993(TRADITIONAL)
ATTN: DIANE  HORWITZ, PH.D.       PHONE NO : 703 307 2921   
2995 STEVEN MARTIN DR.            SE DECISION MADE: 25-OCT-12
FAIRFAX VA 22031                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPERMFREEZE SOLUTION
VITROLIFE SWEDEN AB               510(k) NO: K113786(TRADITIONAL)
ATTN: NINA  ARVIDSSON             PHONE NO : 463 172 18076
BOX 9080                          SE DECISION MADE: 26-OCT-12
GOTEBORG    SW SE-40092           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LEGACY-500
MT TABLES, LLC                    510(k) NO: K111588(TRADITIONAL)
ATTN: MILBURN  TENNIS             PHONE NO : 417 678 2880   
15 W. MILL STREET                 SE DECISION MADE: 26-OCT-12
AURORA MO 65605                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM
SWAN VALLEY MEDICAL, INCORPORATED 510(k) NO: K120127(TRADITIONAL)
ATTN: KEVIN  RANDALL              PHONE NO : 303 828 0844   
16576 W. 53RD WAY                 SE DECISION MADE: 26-OCT-12
GOLDEN CO 80403                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZOLL FULLY AUTOMATIC AED PLUS
ZOLL MEDICAL CORPORATION, WORLD WI510(k) NO: K120406(TRADITIONAL)
ATTN: TANMAY B SHUKLA             PHONE NO : 978 421 9171   
269 MILL ROAD                     SE DECISION MADE: 26-OCT-12
CHELMSFORD MA 01824 4105          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ECHONAVIGATOR RELEASE 1
PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K121781(ABBREVIATED)
ATTN: FRANS  JACOBS               PHONE NO : 316 512 0741
VEENPLUIS 4-6                     SE DECISION MADE: 26-OCT-12
BEST    NL 5684 PC                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKER
SUPERDIMENSION INC.               510(k) NO: K120796(TRADITIONAL)
ATTN: KARYL  HASKELL              PHONE NO : 763 210 4000   
161 CHESHIRE LANE NORTH SUITE 100 SE DECISION MADE: 26-OCT-12
Minneapolis MN 55441              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CHG ANTIBACTERIAL FOAM DRESSING, CHG ANTIBACTERIAL PATCH, CHG ANTIBACTERIAL FOAM PATCH, CHG PATCH, CHG DRESSING
MEDTECH PRODUCTS LTD.             510(k) NO: K120930(TRADITIONAL)
ATTN: CLAIRE  RYAN                PHONE NO : 440 127 0500019
ELECTRA HOUSE, CREWE BUSINESS PARKSE DECISION MADE: 26-OCT-12
CHESHIRE    UK CW1 6GL            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ABL90 FLEX
RADIOMETER MEDICAL APS            510(k) NO: K122642(SPECIAL)
ATTN: MARTIN  GABLER              PHONE NO : 45 38 273114
AKANDEVEJ 21                      SE DECISION MADE: 26-OCT-12
BRONSHOJ    DA DK-2700            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SAVIE-AQUA 55UV (METHAFILCON A) TINNTED BLUE SOFT (HYDROPHILIC) CONTACT LENS
ST. SHINE OPTICAL CO., LTD.       510(k) NO: K121201(TRADITIONAL)
ATTN: ELLA  LEE                   PHONE NO : 886 226 479356
4,5 F/L NO. 276-2 SEC. 1 TATUNG RDSE DECISION MADE: 26-OCT-12
NEW TAIPEI CITY    TW 221         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACUSON X700 DIAGNSTIC ULTRASOUND SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K123001(TRADITIONAL)
ATTN: SHELLY  PEARCE              PHONE NO : 650 694 5988   
685 East Middlefield Road         SE DECISION MADE: 26-OCT-12
Mountain View CA 94043            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM
BIO-RAD LABORATORIES, INC., CLINIC510(k) NO: K122472(TRADITIONAL)
ATTN: JACKIE  BUCKLEY             PHONE NO : 510 741 5309   
4000 Alfred Nobel Drive           SE DECISION MADE: 26-OCT-12
Hercules CA 94547                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THE CANARY SYSTEM
QUANTUM DENTAL TECHNOLOGIES INC   510(k) NO: K112139(TRADITIONAL)
ATTN: JOSH  SILVERTOWN            PHONE NO : 647 205 4402
748 BRIAR HILL AVENUE             SE DECISION MADE: 26-OCT-12
TORONTO, ONTARIO    CA M6B 1L3    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIQUIDBAND FLOW CONTROL
ADVANCED MEDICAL SOLUTIONS (PLYMOU510(k) NO: K122446(TRADITIONAL)
ATTN: MICHAEL  BROWNE             PHONE NO : 441 752 209955
WESTERN WOOD WAY LANAGAGE SCIENCE SE DECISION MADE: 26-OCT-12
PLYMOUTH    UK PL7 5BG            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COLUMBUS REVISION KNEE SYSTEM
AESCULAP IMPLANT SYSTEM, INC.     510(k) NO: K122985(SPECIAL)
ATTN: JULIE TOM  WING             PHONE NO : 610 984 9147   
3773 CORPORATE PWKY.              SE DECISION MADE: 26-OCT-12
CENTER VALLEY PA 18034            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
CARTICEPT MEDICAL, INC.           510(k) NO: K122215(SPECIAL)
ATTN: TANYA  EBERLE               PHONE NO : 770 754 3800   
6120 Windward Pkwy Ste 220        SE DECISION MADE: 26-OCT-12
Alpharetta GA 30005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLOW2, SWING
THYSSENKRUPP ACCESSIBILITY B.V.   510(k) NO: K121561(TRADITIONAL)
ATTN: ARNOLD  HEIDEN              PHONE NO : 31 180 530900
VAN UTRECHTWEG 99 KRIMPEN AAN DEN SE DECISION MADE: 26-OCT-12
ZUID-HOLLAND    NL 2921 LN        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SKINTEMP II
HUMAN BIOSCIENCES, INC.           510(k) NO: K122325(TRADITIONAL)
ATTN: JACK  SLOVICK               PHONE NO : 763 639 0238   
2913, 209TH LANE NW               SE DECISION MADE: 26-OCT-12
OAK GROVE MN 55011                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RENEW INSERT
RENEW MEDICAL, INC.               510(k) NO: K122003(TRADITIONAL)
ATTN: VICTORIA  MACKINNON         PHONE NO : 650 863 3167   
532 EMERSON STREET                SE DECISION MADE: 26-OCT-12
PALO ALTO CA 94301                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TORQUE DEVICE
BOSTON SCIENTIFIC CORPORATION     510(k) NO: K123024(SPECIAL)
ATTN: RACHEL  OWENS               PHONE NO : 763 494 1491   
ONE SCIMED PLACE                  SE DECISION MADE: 26-OCT-12
MAPLE GROVE MN 55311              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REX ANTERIOR CERVICAL PLATE SYSTEM
DIO MEDICAL CO., LTD.             510(k) NO: K121862(TRADITIONAL)
ATTN: APRIL  LEE                  PHONE NO : 714 525 0114   
325 N. PUENTE ST UNIT B           SE DECISION MADE: 30-OCT-12
BREA CA 92821                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOPRO HEMI-EDGE TOE SYSTEM
BIOPRO, INC.                      510(k) NO: K121973(TRADITIONAL)
ATTN: AL  LIPPINCOTT              PHONE NO : 952 492 5858   
3150 E. 200TH ST                  SE DECISION MADE: 30-OCT-12
PRIOR LAKE MN 55372               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ERGOSELECT/GE
ERGOLINE GMBH                     510(k) NO: K112121(TRADITIONAL)
ATTN: ANDREA  PECSI               PHONE NO : 497 462 924051
SCHWARZWALDSTRASSE 5              SE DECISION MADE: 31-OCT-12
TUTTLINGEN    GM 78532            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AAP LOQTEQ PROXIMAL LATERAL TIBIA PLATE 4.5 SYSTEM
AAP IMPLANTATE AG                 510(k) NO: K113602(TRADITIONAL)
ATTN: MARC  SEEGERS               PHONE NO : 004 930 75019192
LORENZWEG 5                       SE DECISION MADE: 31-OCT-12
BERLIN    GM 12099                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LOFRIC PRIMO, LOFRIC HYDRO-KIT
ASTRA TECH, INC.                  510(k) NO: K122078(TRADITIONAL)
ATTN: ALLISON C KOMIYAMA          PHONE NO : 858 792 1235   
11234 EL CAMINO REAL, STE 200     SE DECISION MADE: 31-OCT-12
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFIED TREVO RETRIEVER
CONCENTRIC MEDICAL, INC.          510(k) NO: K122478(TRADITIONAL)
ATTN: CHRISTINA  ROWE             PHONE NO : 510 413 2486   
301 E Evelyn Ave                  SE DECISION MADE: 31-OCT-12
MOUNTAIN VIEW CA 94041            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COSENSE
CAPNIA, INC.                      510(k) NO: K121768(TRADITIONAL)
ATTN: JULIE  BLACKLOCK            PHONE NO : 650 213 8444   
2445 FABER PLACE, STUITE 250      SE DECISION MADE: 31-OCT-12
PALO ALTO CA 94303                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WINX SLEEP THERAPY SYSTEM
APNICURE, INC.                    510(k) NO: K122130(SPECIAL)
ATTN: CHRIS  DANIEL               PHONE NO : 650 361 9300   
900 CHESAPEAKE DR                 SE DECISION MADE: 31-OCT-12
REDWOOD CITY CA 94063             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CANOPY LAMINOPLASTY FIXATION SYSTEM
GLOBUS MEDICAL INC.               510(k) NO: K121732(SPECIAL)
ATTN: SARAH  MARIE FITZGERALD     PHONE NO : 610 930 1800   
2560 GENERAL ARMISTEAD AVE.       SE DECISION MADE: 31-OCT-12
AUDUBON PA 19403                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL
MEDTRONIC XOMED                   510(k) NO: K122434(SPECIAL)
ATTN: ANTOINE  KOUCHAKJY          PHONE NO : 904 296 9600   
6743 SOUTHPOINT DR. NORTH         SE DECISION MADE: 31-OCT-12
JACKSONVILLE FL 32216             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STRYKER UNIVERSAL SMARTLOCK HYBRID MMF SYSTEM
STRYKER                           510(k) NO: K122313(TRADITIONAL)
ATTN: ROB  YAMASHITA              PHONE NO : 269 389 4258   
750 TRADE CENTER WAY STE 200      SE DECISION MADE: 31-OCT-12
PORTAGE MI 49002                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUATRO LINK KNOTLESS ANCHOR WITH INSERTER, 2.9MM-PEEK ONLY
CAYENNE MEDICAL, INC.             510(k) NO: K122314(TRADITIONAL)
ATTN: KERESHMEH  SHAHRIARI        PHONE NO : 480 502 3661   
16597 N. 92ND STREET SUITE 101    SE DECISION MADE: 31-OCT-12
SCOTTSDALE AZ 85260               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CERTEX SPINAL IMPLANT SYSTEM
X-SPINE SYSTEMS, INC              510(k) NO: K122163(TRADITIONAL)
ATTN: DAVID  KIRSCHMAN            PHONE NO : 937 847 8400   
452 Alexandersville Rd            SE DECISION MADE: 31-OCT-12
Miamisburg OH 45342               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTIFLEX TINNITUS TECHNOLOGY
STARKEY LABORATORIES              510(k) NO: K122876(TRADITIONAL)
ATTN: KEN  MEYER                  PHONE NO : 952 947 4734   
6600-6700 WASHINGTON AVE SO.      SE DECISION MADE: 31-OCT-12
EDEN PRAIRIE MN 55344             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW


                                                 TOTAL 510(k)s THIS PERIOD   260                                     
                                                 TOTAL WITH SUMMARIES        249                                     
                                                 TOTAL WITH STATEMENTS        11