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U.S. Department of Health and Human Services

Medical Devices

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November 2012 510(k) Clearances

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


DEVICE: FRONTIER SADL INTERBODY FUSION DEVICE
FRONTIER MEDICAL DEVICES, INC.    510(k) NO: K112700(TRADITIONAL)
ATTN: RICH  JANSEN                PHONE NO : 612 281 5505   
13540 GUILD AVENUE                SE DECISION MADE: 01-NOV-12
APPLE VALLEY MN 55124             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXTENDED LIFE BATTERY
AED BATTERY EXCHANGE, LLC         510(k) NO: K120350(TRADITIONAL)
ATTN: KEITH  HOCHHALTER           PHONE NO : 847 487 9375   
1000 BROWN STREET SUITE 310       SE DECISION MADE: 01-NOV-12
WAUCONDA IL 60084                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COLLAGEN DENTAL WOUND DRESSINGS
COLLAGEN MATRIX, INC.             510(k) NO: K122115(TRADITIONAL)
ATTN: PEGGY  HANSEN               PHONE NO : 201 405 1477   
15 THORNTON ROAD                  SE DECISION MADE: 01-NOV-12
OAKLAND NJ 07436                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STRYKER CMF MEDPOR CUSTOMIZED IMPLANT
HOWMEDICA OSTEONICS CORP.         510(k) NO: K121315(TRADITIONAL)
ATTN: STEPHANIE  FULLARD          PHONE NO : 770 254 4400   
15 Dart Rd                        SE DECISION MADE: 01-NOV-12
NEWNAN GA 30265                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRESSURIZED INFUSION PUMP
MUI SCIENTIFIC                    510(k) NO: K122294(TRADITIONAL)
ATTN: TAMMY  MUI                  PHONE NO : 905 890552 5
145 TRADERS BLVD. EAST, # 34      SE DECISION MADE: 01-NOV-12
MISSISSAUGA    CA L4Z 3L3         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LEVANT, HOMEGLIDE
THYSSENKRUPP ACCESSIBILITY B.V.   510(k) NO: K121560(TRADITIONAL)
ATTN: ARNOLD  HEIDEN              PHONE NO : 31 180 530900
VAN UTRECHTWEG 99 KRIMPEN AAN DEN SE DECISION MADE: 01-NOV-12
ZUID-HOLLAND    NL 2921 LN        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON
AUDIFON-USA INC.                  510(k) NO: K121793(ABBREVIATED)
ATTN: JANE E PERRONE              PHONE NO : 386 668 8812   
403 CHAIRMAN CT., STE. 1          SE DECISION MADE: 01-NOV-12
DEBARY FL 32713                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999
STRYKER SPINE                     510(k) NO: K122637(TRADITIONAL)
ATTN: TINA  MORNAK                PHONE NO : 201 760 8193   
2 PEARL COURT                     SE DECISION MADE: 01-NOV-12
ALLENDALE NJ 07401                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM
BIO-LOGIC SYSTEMS CORP.           510(k) NO: K122496(TRADITIONAL)
ATTN: TIMOTHY  KARLOVSKY          PHONE NO : 847 949 5200   
ONE BIOLOGIC PLAZA                SE DECISION MADE: 01-NOV-12
MUNDELEIN IL 60060                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TAP PAP NASAL PILLOW MASK
AIRWAY MANAGEMENT, INC.           510(k) NO: K122350(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DRIVE              SE DECISION MADE: 01-NOV-12
BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TAMARIN BLUE PTCA RX DILATATION CATHETER
NATEC MEDICAL LTD                 510(k) NO: K112735(TRADITIONAL)
ATTN: E.J.  SMITH                 PHONE NO : 888 729 9674   
1468 HARWELL AVENUE               SE DECISION MADE: 02-NOV-12
CROFTON MD 21114                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BARD PTV DILATATION CATHETER
C.R. BARD, INC.                   510(k) NO: K122367(TRADITIONAL)
ATTN: ERIN  FOX                   PHONE NO : 480 379 2841   
1625 W. THIRD STREET              SE DECISION MADE: 02-NOV-12
TEMPE AZ 85281                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RN TEMPORARY ABUTMENT, CAD-TEMP, PMMA WN TEM
STRAUMANN USA, LLC                510(k) NO: K122192(TRADITIONAL)
ATTN: ELAINE  ALAN                PHONE NO : 978 747 2513   
60 MINUTEMAN ROAD                 SE DECISION MADE: 02-NOV-12
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RESUSCITAIRE WITH AUTOBREATH
DRAEGER MEDICAL SYSTEMS, INC.     510(k) NO: K120642(TRADITIONAL)
ATTN: GALE  WINARSKY              PHONE NO : 215 660 2239   
3135 QUARRY RD.                   SE DECISION MADE: 02-NOV-12
TELFORD PA 18969                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EC 2.7 ENDOSCOPIC CUTTER
MEDTRONIC ADVANCED ENERGY, LLC    510(k) NO: K120909(TRADITIONAL)
ATTN: MARTIN J LEIGHTON           PHONE NO : 603 294 5446   
180 INTERNATIONAL DRIVE           SE DECISION MADE: 02-NOV-12
PORTSMOUTH NH 03801               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLO-GUARD BREATHING FILTER
INTERSURGICAL, INC.               510(k) NO: K121026(TRADITIONAL)
ATTN: MICHAEL  ZALEWSKI           PHONE NO : 315 451 2900   
417 ELECTRONICS PKWY.             SE DECISION MADE: 02-NOV-12
LIVERPOOL NY 13088                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REVELATION POROUS COATED HIP STEM, SIZE 8
ENCORE MEDICAL, L.P.              510(k) NO: K122636(SPECIAL)
ATTN: TEFFANY  HUTTO              PHONE NO : 512 834 6255   
9800 METRIC BLVD.                 SE DECISION MADE: 02-NOV-12
AUSTIN TX 78758                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCH
CARL ZEISS MEDITEC AG             510(k) NO: K122938(TRADITIONAL)
ATTN: JUDY  BRIMACOMBE            PHONE NO : 925 557 4616   
5160 HACIENDA DRIVE               SE DECISION MADE: 02-NOV-12
DUBLIN CA 94568                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX)
CEPHEID                           510(k) NO: K121539(TRADITIONAL)
ATTN: KERRY J FLOM                PHONE NO : 408 400 8460   
904 CARIBBEAN DRIVE               SE DECISION MADE: 02-NOV-12
SUNNYVALE CA 94089 1189           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITREAADVANCED
VITAL IMAGES, INC.                510(k) NO: K121213(TRADITIONAL)
ATTN: DANIEL  BIANK               PHONE NO : 982 487 9514   
5850 OPUS PARKWAY, SUITE 300      SE DECISION MADE: 02-NOV-12
MINNETONKA MN 55343 4414          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0T
INVIVO CORPORATION                510(k) NO: K122646(TRADITIONAL)
ATTN: LISA  SIMPSON               PHONE NO : 352 336 0010   
3545 SW 47TH AVE.                 SE DECISION MADE: 02-NOV-12
GAINESVILLE FL 32608              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARDIOBLATE CRYOFLEX SURGICAL ABLATION PROBES
MEDTRONIC INC.                    510(k) NO: K121878(SPECIAL)
ATTN: KARI  CHRISTIANSON          PHONE NO : 763 514 9529   
8200 CORAL SEA STREET NE MAIL STOPSE DECISION MADE: 02-NOV-12
MOUNDS VIEW MN 55112              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLIGHTPLAN FOR LIVER
GE HEALTHCARE                     510(k) NO: K121200(TRADITIONAL)
ATTN: CAROL  ALLOIAN              PHONE NO : 224 280 1008   
9900 W INNOVATION DR              SE DECISION MADE: 02-NOV-12
WAUWATOSA WI 53226 4856           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING
C.R. BARD, INC.                   510(k) NO: K123179(SPECIAL)
ATTN: MICHELE  DAVIS              PHONE NO : 770 784 6274   
8195 INDUSTRIAL BLVD.             SE DECISION MADE: 02-NOV-12
COVINGTON GA 30014                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DC-8/DC-8 PRO/DC-8, CV/DC-8, EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K123185(TRADITIONAL)
ATTN: ZHAI  PEI                   PHONE NO : 867 558188 5604
MINDRAY BUILDING, KEJI 12TH ROAD SSE DECISION MADE: 02-NOV-12
SHENZHEN    CH 518057             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: TANGO M2 BLOOD PRESSURE MONITOR
SUNTECH MEDICAL, INC.             510(k) NO: K122401(SPECIAL)
ATTN: CHUCK  SETZER               PHONE NO : 919 654 2300   
507 AIRPORT BOULEVARD SUITE 117   SE DECISION MADE: 02-NOV-12
MORRISVILLE NC 27560              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LATEX MALE CONDOM (SMOOTH SURFACE) LATEX MALE CONDOM (TEXTURED SURFACE)
MEDICAL-LATEX (DUA) SDN. BHD      510(k) NO: K120555(ABBREVIATED)
ATTN: UMA  DEVI                   PHONE NO : 607 597 8100
PLO 8 SENAI INDUSTRIAL ESTATE     SE DECISION MADE: 02-NOV-12
SENAI    MY 81400                 510(k) STATEMENT

DEVICE: COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM
C.R. BARD, INC.                   510(k) NO: K122436(SPECIAL)
ATTN: KETI  SINO                  PHONE NO : 401 825 8575   
100 CROSSINGS BOULEVARD           SE DECISION MADE: 02-NOV-12
WARWICK RI 02886                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRUSCULPT
CUTERA, INC.                      510(k) NO: K122389(SPECIAL)
ATTN: CONNIE  HOY                 PHONE NO : 415 657 5586   
3240 BAYSHORE BLVD                SE DECISION MADE: 02-NOV-12
BRISBANE CA 94005                 510(k) STATEMENT

DEVICE: BIOPLEX 2200 EBV IGM KIT
BIO-RAD LABORATORIES              510(k) NO: K123021(TRADITIONAL)
ATTN: JUANG  WANG                 PHONE NO : 510 741 4609   
5500 SECOND ST                    SE DECISION MADE: 02-NOV-12
BENICIA CA 94510                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURFFLASH(R) PLUS SAFETY I.V. CATHETER
KOFU FACTORY OF TERUMO CORP.      510(k) NO: K123267(TRADITIONAL)
ATTN: SANDI  HARTKA               PHONE NO : 410 392 7243   
950 ELKTON BLVD                   SE DECISION MADE: 02-NOV-12
ELKTON MD 21921                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: IUI CATHETERS
KITAZATO MEDICAL CO., LTD.        510(k) NO: K112396(TRADITIONAL)
ATTN: RICHARD  VINCINS            PHONE NO : 512 327 9997   
611 WEST 5TH STREET               SE DECISION MADE: 02-NOV-12
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM
ACCLARENT, INC.                   510(k) NO: K120280(TRADITIONAL)
ATTN: DAN  HARFE                  PHONE NO : 650 687 6056   
1525-B OBRIEN DR.                 SE DECISION MADE: 05-NOV-12
MENLO PARK CA 94025               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MINIME 2 NASAL MASK
SLEEPNET CORPORATION              510(k) NO: K121692(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DRIVE              SE DECISION MADE: 05-NOV-12
BONITA SPRINGS FL 34134 2958      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DYMAXEON SPINE SYSTEM
B2B SPINE PTY LTD                 510(k) NO: K121786(TRADITIONAL)
ATTN: JUSTIN  EGGLETON            PHONE NO : 202 552 5804   
1331 H ST NW 12 FL                SE DECISION MADE: 05-NOV-12
WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO
SIEMENS MEDICAL SOLUTIONS, INC.   510(k) NO: K121434(TRADITIONAL)
ATTN: MICHELLE L BYRNE            PHONE NO : 610 448 4293   
51 VALLEY STREAM PARKWAY MAIL CODESE DECISION MADE: 05-NOV-12
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VAPR P50 SUCTION ELECTRODE VAPR S90 SUCTION ELECTRODE VAPR P50 SUCTION ELECTRODE WITH HANDCONTROLS VAPRS90 SUCTION ELECT
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K122425(TRADITIONAL)
ATTN: YAYOI  FUJIMAKI             PHONE NO : 508 828 3541   
325 PARAMOUNT DR.                 SE DECISION MADE: 05-NOV-12
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT
TGM MEDICAL, INC.                 510(k) NO: K121509(TRADITIONAL)
ATTN: PRAKASH  PAI                PHONE NO : 916 358 8835   
5145 Golden Foothill Parkway SuiteSE DECISION MADE: 05-NOV-12
El Dorado Hills CA 95762          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CS2 HIP SYSTEM
CONSENSUS ORTHOPEDICS, INC.       510(k) NO: K122512(TRADITIONAL)
ATTN: MATTHEW M HULL              PHONE NO : 916 355 7100   
1115 WINDFIELD WAY, SUITE 100     SE DECISION MADE: 05-NOV-12
EL DORADO HILLS CA 95762          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THE ABLATION SYSTEM
HALT MEDICAL INC.                 510(k) NO: K121858(TRADITIONAL)
ATTN: CLARISA  TATE               PHONE NO : 925 271 0626   
131 Sand Creek Road, Suite B      SE DECISION MADE: 05-NOV-12
Brentwood CA 94513                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OSOM INFLUENZA A&B TEST MODEL 190
SEKISUI DIAGNOSTICS, LLC          510(k) NO: K123182(SPECIAL)
ATTN: MARK  STAVRO                PHONE NO : 858 777 2633   
6659 Top Gun St                   SE DECISION MADE: 05-NOV-12
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALTIS SINGLE INCISION CLING SYSTEM
COLOPLAST A/S                     510(k) NO: K121562(TRADITIONAL)
ATTN: JANELL A COLLEY             PHONE NO : 612 287 4211   
1601 WEST RIVER ROAD NORTH        SE DECISION MADE: 05-NOV-12
MINNEAPOLIS MN 55411              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLEXIPORT ECOCUFF
WELCH ALLYN, INC.                 510(k) NO: K122058(TRADITIONAL)
ATTN: KEVIN  CROSSEN              PHONE NO : 315 685 2609   
4341 STATE ST. RD. P.O. BOX 220   SE DECISION MADE: 05-NOV-12
SKANEATELES FALLS NY 13153 0220   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INSURGICAL SINGLE USE POWER EQUIPMENT
INSURGICAL LLC                    510(k) NO: K112599(TRADITIONAL)
ATTN: DAVID C FURR                PHONE NO : 512 906 9654   
8708 CAPEHART COVE                SE DECISION MADE: 06-NOV-12
AUSTIN TX 78733                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERIGENE CYP2C19 NUCLEIC ACID TES (2C19)
NANOSPHERE, INC                   510(k) NO: K120466(TRADITIONAL)
ATTN: MARK  DEL VECCHIO           PHONE NO : 847 400 9000   
4088 COMMERCIAL AVENUE            SE DECISION MADE: 06-NOV-12
NORTHBROOK IL 60062               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NYLUS PICC
SEMPRUS BIOSCIENCES               510(k) NO: K113225(TRADITIONAL)
ATTN: NANDINI  MURTHY             PHONE NO : 781 710 5378   
ONE KENDALL SQUARE BUILDING 1400W,SE DECISION MADE: 06-NOV-12
CAMBRIDGE MA 02139                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HU-FRIEDY DENTAL CARTRIDGE SYRINGE
HU-FRIEDY MFG. CO. LLC            510(k) NO: K120659(TRADITIONAL)
ATTN: MARIA  VRABIE               PHONE NO : 773 975 3975   
3232 N ROCKWELL STREET            SE DECISION MADE: 06-NOV-12
CHICAGO IL 60618                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BLUE POWDERED NITRILE EXAMINATION GLOVE
NORTHSTAR HEALTHCARE HOLDINGS     510(k) NO: K122998(TRADITIONAL)
ATTN: ANTHONY  GIACCIO            PHONE NO : 815 385 0100   
1202 SOUTH ROUTE 31               SE DECISION MADE: 06-NOV-12
MCHENRY IL 60050                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: VRESELECT CULTURE MEDIUM
BIO-RAD                           510(k) NO: K122187(TRADITIONAL)
ATTN: FRAN  WHITE                 PHONE NO : 978 927 3808   
180 CABOT STREET                  SE DECISION MADE: 06-NOV-12
BEVERLY MA 01915                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRINITY WRINKLE REMOVER
CAROL COLE COMPANY                510(k) NO: K120560(TRADITIONAL)
ATTN: BOB  DUFFY                  PHONE NO : 858 487 1859   
16405 SUMMER SAGE RD              SE DECISION MADE: 06-NOV-12
POWAY CA 92064                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COMEN MULTI-PARAMETER PATIENT MONITOR
GOLDWAY (US), INC.                510(k) NO: K112877(TRADITIONAL)
ATTN: JIMMY  WU                   PHONE NO : 626 799 0998   
2600 MISSION STREET SUITE 100     SE DECISION MADE: 07-NOV-12
SAN MARINO CA 91108               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENCORE TONGUE SUSPENSION SYSTEM
SIESTA MEDICAL, INC.              510(k) NO: K121814(TRADITIONAL)
ATTN: MICHAEL  KOLBER             PHONE NO : 408 505 6626   
101 CHURCH STREET SUITE 3         SE DECISION MADE: 07-NOV-12
LOS GATOS CA 95030                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM
ZIMMER, INC.                      510(k) NO: K121771(TRADITIONAL)
ATTN: KELLI J ANDERSON            PHONE NO : 574 371 8087   
P.O. BOX 708                      SE DECISION MADE: 07-NOV-12
WARSAW IN 46581 0708              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INOBLENDER
INO THERAPEUTICS                  510(k) NO: K122689(SPECIAL)
ATTN: ROBERT  BOVY                PHONE NO : 608 226 3450   
2902 DAIRY DRIVE                  SE DECISION MADE: 07-NOV-12
MADISON WI 53718                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLEARLUMEN THROMBECTOMY SYSTEM
WALK VASCULAR LLC                 510(k) NO: K120508(TRADITIONAL)
ATTN: DAVID  LOOK                 PHONE NO : 949 752 9642   
17171 DAIMLER ST                  SE DECISION MADE: 07-NOV-12
IRVINE CA 92614                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OCELOT SYSTEM
AVINGER, INC.                     510(k) NO: K122380(TRADITIONAL)
ATTN: ALBERT  BONISKE             PHONE NO : 650 241 7004   
400 CHESAPEAKE DRIVE              SE DECISION MADE: 07-NOV-12
REDWOOD CITY CA 94063             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER)
HANGZHOU HUA'AN MEDICAL & HEALTH I510(k) NO: K122912(SPECIAL)
ATTN: AHNEO  YANG                 PHONE NO : 865 718873 4065
BLDG 2, BAIMIAO IND. PARK ECONOMICSE DECISION MADE: 07-NOV-12
WUCHANG, HANGZHOU, ZHEJIANG    CH 510(k) STATEMENT

DEVICE: GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SET
SOLANA SURGICAL LLC               510(k) NO: K122738(TRADITIONAL)
ATTN: REBECCA  WAHL               PHONE NO : 901 818 1860   
6363 POPLAR AVE SUITE 434         SE DECISION MADE: 07-NOV-12
MEMPHIS TN 38119                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HAMMER TOE IMPLANT
TRILLIANT SURGICAL LTD            510(k) NO: K122959(TRADITIONAL)
ATTN: J D WEBB                    PHONE NO : 512 388 0199   
1001 OAKWOOD BLVD                 SE DECISION MADE: 07-NOV-12
ROUND ROCK TX 78681               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Z-SNAP OFF SCREW, Z-DOUBLE THREAD COMPRESSION SCREW, Z-GUIDE WIRE, Z-STAPLE
Z-MEDICAL GMBH & CO. KG           510(k) NO: K121277(TRADITIONAL)
ATTN: ALEXANDER  HENNINGER        PHONE NO : 497 462 945540
GANSACKER 38                      SE DECISION MADE: 07-NOV-12
TUTTLINGEN, BADEN-WUERTTEMBERG    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATOR
BAYLIS MEDICAL COMPANY INC.       510(k) NO: K122278(TRADITIONAL)
ATTN: MEGHAL  KHAKHAR             PHONE NO : 905 602 4575
2645 MATHESON BLVD. EAST          SE DECISION MADE: 07-NOV-12
MISSISSAUGA    CA L4W 5S4         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM
PIONEER SURGICAL TECHNOLOGY, INC  510(k) NO: K121725(TRADITIONAL)
ATTN: SARAH  MCINTYRE             PHONE NO : 906 225 5861   
375 RIVER PARK CIRCLE             SE DECISION MADE: 07-NOV-12
Marquette MI 49855                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100
PEGASUS RESEARCH CORP.            510(k) NO: K122857(TRADITIONAL)
ATTN: KENNETH  MILLER             PHONE NO : 714 241 7077   
3303 HARBO BLVD SUITE F3          SE DECISION MADE: 07-NOV-12
COSTA MESA CA 92626               510(k) STATEMENT

DEVICE: SMARTSTITCH PERFECTPASSER SYSTEM
ARTHOCARE CORPORATION             510(k) NO: K123268(SPECIAL)
ATTN: CHERYL  FREDERICK           PHONE NO : 512 358 5751   
7000 WEST WILLIAM CANNON DRIVE    SE DECISION MADE: 07-NOV-12
AUSTIN TX 78735                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DCS LACRIMAL STENT
DCS SURGICAL INC                  510(k) NO: K113316(TRADITIONAL)
ATTN: HARRY  ROSS                 PHONE NO : 303 929 9909   
1110 LINDEN AVE.                  SE DECISION MADE: 08-NOV-12
BOULDER CO 80304                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CORVIS ST
OCULUS OPTIKGERATE GMBH           510(k) NO: K113066(TRADITIONAL)
ATTN: ECKHARD  LOH                PHONE NO : 490 641 20050
MUNCHHOLZHAUSER STR. 29           SE DECISION MADE: 08-NOV-12
WETZLAR    GM D-35582             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AAP  LOQTEQ DISTAL MEDIAL TIBIA PLATE 3.5 SYSTEM
AAP IMPLANTATE AG                 510(k) NO: K113601(TRADITIONAL)
ATTN: MARC  SEEGERS               PHONE NO : 004 930 75019192
LORENZWEG 5                       SE DECISION MADE: 08-NOV-12
BERLIN    GM 12099                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MTF FASCIA
MUSCULOSKELETAL TRANSPLANT FOUNDAT510(k) NO: K120479(TRADITIONAL)
ATTN: RANDY  PREBULA              PHONE NO : 202 637 6548   
555 THIRTEENTH STREET, N.W.       SE DECISION MADE: 08-NOV-12
WASHINGTON DC 20004 5794          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TERUMO(R) NEEDLE
TERUMO (PHILIPPINES) CORPORATION  510(k) NO: K121607(TRADITIONAL)
ATTN: SANDI  HARTKA               PHONE NO : 410 392 7243   
950 ELKTON BLVD                   SE DECISION MADE: 08-NOV-12
ELKTON MD 21921                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STINGRAY GUIDEWIRES
BRIDGEPOINT MEDICAL               510(k) NO: K122795(SPECIAL)
ATTN: JILL  MUNSINGER             PHONE NO : 763 225 8500   
13355 10TH AVE N, SUITE #110      SE DECISION MADE: 08-NOV-12
PLYMOUTH MN 55441                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZIMMER ZFX ABUTMENT FOR NOBEL REPLACE IMPLANT SYSTEM
ZIMMER DENTAL INC.                510(k) NO: K120873(TRADITIONAL)
ATTN: MELISSA  BURBAGE            PHONE NO : 760 929 4300   
1900 ASTON AVE.                   SE DECISION MADE: 08-NOV-12
CARLSBAD CA 92008 7308            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALN OPTIONAL VANA CAVA FILTER
ALN IMPLANTS CHIRURGICAUX         510(k) NO: K113124(ABBREVIATED)
ATTN: CYNTHIA  COTTEREAU          PHONE NO : 33 545 321884
2 RUE QUENOT                      SE DECISION MADE: 09-NOV-12
JARNAC    FR 16200                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VOLTERA POWERED SUCTION PUMP
SUZRIC ENTERPRISE CO., LTD.       510(k) NO: K112853(TRADITIONAL)
ATTN: MICHAEL  LEE                PHONE NO : 886 228 096995
NO. 77, KEJI 2ST ROAD GUISHAN TOWNSE DECISION MADE: 09-NOV-12
TAOYUAN COUNTY    TW 333          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
HMD BIOMEDICAL, INC.              510(k) NO: K113314(TRADITIONAL)
ATTN: WANG  YUNHAN                PHONE NO : 886 360 17000
#181 MINSHENG STREET              SE DECISION MADE: 09-NOV-12
XINPU TOWNSHIP    TW 30542        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PSG-1100 SLEEP DIAGNOSTIC SYSTEM
NIHON KOHDEN CORP.                510(k) NO: K120888(SPECIAL)
ATTN: STEVE  GEERDES              PHONE NO : 949 580 1555   
90 ICON STREET                    SE DECISION MADE: 09-NOV-12
FOOTHILL RANCH CA 92610           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: H-MAX S FEMORAL STEMS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS
LIMACORPORATE S.P.A.              510(k) NO: K112091(TRADITIONAL)
ATTN: CHERYL  HASTINGS            PHONE NO : 574 527 4220   
P.O. BOX 696                      SE DECISION MADE: 09-NOV-12
WINONA LAKE IN 46590 696          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICRO/MINI N-PK(F) BONE ANCHOR
ANULEX TECHNOLOGIES, INC          510(k) NO: K121354(TRADITIONAL)
ATTN: RACHEL  KENNEDY             PHONE NO : 952 224 4034   
5600 ROWLAND ROAD, STE 280        SE DECISION MADE: 09-NOV-12
MINNETONKA MN 55343               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICRO/MINI N-PK(H) BONE ANCHOR
ANULEX TECHNOLOGIES, INC          510(k) NO: K121356(TRADITIONAL)
ATTN: RACHEL  KENNEDY             PHONE NO : 952 224 4034   
5600 ROWLAND ROAD, STE 280        SE DECISION MADE: 09-NOV-12
MINNETONKA MN 55343               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REGEN SPRAY APPLICATOR,
REGEN LAB SA                      510(k) NO: K122122(TRADITIONAL)
ATTN: GUY  FORTIER                PHONE NO : 514 817 6704
3428 AVENUE MARCIL                SE DECISION MADE: 09-NOV-12
MONTREAL    CA H4A 2Z3            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CRIT-LINE CLIP (CLIC)
FRESENIUS MEDICAL CARE-NORTH AMERI510(k) NO: K121599(TRADITIONAL)
ATTN: DENISE  OPPERMANN           PHONE NO : 781 699 4479   
920 WINTER STREET                 SE DECISION MADE: 09-NOV-12
WALTHAM MA 02451                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AEM DISPOSABLE SUCTION IRRIGATION HANDSET MODEL ES1700; AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES MODEL ES077X SERIES
ENCISION, INC.                    510(k) NO: K122580(TRADITIONAL)
ATTN: JIM  LEWIS                  PHONE NO : 303 444 2600   
6797 WINCHESTER CIR.              SE DECISION MADE: 09-NOV-12
BOULDER CO 80301                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIR-BAND RADIAL COMPRESSION DEVICE
DATASCOPE CORP., CARDIAC ASSIST DI510(k) NO: K122405(TRADITIONAL)
ATTN: CARLA S CERQUEIRA           PHONE NO : 973 709 7340   
15 LAW DR.                        SE DECISION MADE: 09-NOV-12
FAIRFIELD NJ 07004 0011           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEWPORT AURA VENTILATOR
NEWPORT MEDICAL INSTRUMENTS, INC. 510(k) NO: K121891(TRADITIONAL)
ATTN: TOM  COLONNA                PHONE NO : 714 427 5811   
1620 SUNFLOWER AVE.               SE DECISION MADE: 09-NOV-12
COSTA MESA CA 92626               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PERSONA NATURAL TIBIA BASEPLATES
ZIMMER INC.                       510(k) NO: K122765(TRADITIONAL)
ATTN: NICOLE J MEREDITH           PHONE NO : 574 372 4517   
P.O. BOX 708                      SE DECISION MADE: 09-NOV-12
WARSAW IN 46581 0708              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERTIFLEX DIRECT DECOMPRESSION SYSTEM
VERTIFLEX, INC.                   510(k) NO: K122662(TRADITIONAL)
ATTN: STEVE  REITZLER             PHONE NO : 949 940 4134   
1351 CALLE AVANZADO               SE DECISION MADE: 13-NOV-12
SAN CLEMENTE CA 92673             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OPTIMA MR 430S
GE MEDICAL SYSTEMS, LLC           510(k) NO: K123068(SPECIAL)
ATTN: YUAN  MA                    PHONE NO : 781 262 5581   
301 BALLARDVALE STREET SUITE 4    SE DECISION MADE: 13-NOV-12
WILMINGTON MA 01887               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX
NCONTACT SURGICAL, INC.           510(k) NO: K120857(TRADITIONAL)
ATTN: JANE  RICUPERO              PHONE NO : 919 655 1355   
1001 AVIATION PARKWAY STE 400     SE DECISION MADE: 13-NOV-12
MORRISVILLE NC 27560              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VPAP S-A
RESMED LTD.                       510(k) NO: K122324(TRADITIONAL)
ATTN: JIM  CASSI                  PHONE NO : 858 836 6081   
9001 SPECTRUM CENTER BLVD.        SE DECISION MADE: 13-NOV-12
SAN DIEGO CA 92123                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HIGH FLOW INSUFFLANTION UNIT
OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K122180(TRADITIONAL)
ATTN: DAPHNEY  GERMAIN-KOLAWOLE   PHONE NO : 484 896 5691   
3500 CORPORATE PARKWAY PO BOX 610 SE DECISION MADE: 13-NOV-12
CENTER VALLEY PA 18034 0610       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZOEFLUID STATUS MONITOR (MODEL ZOE 2B)
NONINVASIVE MEDICAL TECHNOLOGIES, 510(k) NO: K112830(TRADITIONAL)
ATTN: MARC  O'GRIOFA              PHONE NO : 704 614 3360   
6412 S. ARVILLE STREET            SE DECISION MADE: 13-NOV-12
LAS VEGAS NV 89118                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENCORE 26 ADVANTAGE KIT
BOSTON SCIENTIFIC CORP.           510(k) NO: K123214(SPECIAL)
ATTN: RACHEL  OWENS               PHONE NO : 763 494 1491   
ONE SCIMED PLACE                  SE DECISION MADE: 13-NOV-12
MAPLE GROVE MN 55311              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PASCAL LASER INDIRECT OPHTHALMOSCOPE
TOPCON MEDICAL LASER SYSTEMS, INC.510(k) NO: K123056(SPECIAL)
ATTN: PAMELA M BUCKMAN            PHONE NO : 925 980 7007   
2800 PLEASANT HILL RD SUITE 175   SE DECISION MADE: 13-NOV-12
PLEASANT HILL CA 94523            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KLS MARTIN RECON TALON
KLS MARTIN L.P.                   510(k) NO: K122860(TRADITIONAL)
ATTN: JENNIFER  DAMATO            PHONE NO : 800 625 1557   
11201 SAINT JOHNS INDUSTRIAL PARKWSE DECISION MADE: 14-NOV-12
JACKSONVILLE FL 32246             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR
MEDTRONIC INC.                    510(k) NO: K113380(TRADITIONAL)
ATTN: THOMAS  REICHEL             PHONE NO : 763 526 9693   
7000 CENTRAL AVENUE NE            SE DECISION MADE: 15-NOV-12
MINNEAPOLIS MN 55432 3576         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY
HANS BIOMED CORP.                 510(k) NO: K113728(TRADITIONAL)
ATTN: PATSY J TRISLER             PHONE NO : 301 652 5344   
5600 WISCONSIN AVENUE #509        SE DECISION MADE: 15-NOV-12
CHEVY CHASE MD 20815              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FEMMYCYCLE
FEMCAP INCORPORATED               510(k) NO: K121857(TRADITIONAL)
ATTN: ALBERT  REGO                PHONE NO : 949 770 8710   
27001 LA PAZ ROAD, SUITE 312      SE DECISION MADE: 15-NOV-12
MISSION VIEJO CA 92691            510(k) STATEMENT

DEVICE: WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU;
GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K122904(SPECIAL)
ATTN: JOE  SHIA                   PHONE NO : 240 505 7880   
504 EAST DIAMOND AVE. SUITE F     SE DECISION MADE: 15-NOV-12
GAITHERSBRUG MD 20878             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING
HEMOSTASIS, LLC                   510(k) NO: K122886(SPECIAL)
ATTN: BERNARD  HORWATH            PHONE NO : 651 231 1761   
4486 TIMBERLINE CT                SE DECISION MADE: 15-NOV-12
VADNAIS HTS MN 55127              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SJM CONFIRM IMPLANTABLE CARDIAC MONITOR
ST. JUDE MEDICAL, CARDIAC RHYTHM M510(k) NO: K122090(TRADITIONAL)
ATTN: PLESSY  PAUL                PHONE NO : 818 493 3134   
15900 VALLEY VIEW CT.             SE DECISION MADE: 15-NOV-12
SYLMAR CA 91342                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAMMOTOME REOLVE DUAL VACUUM ASSISTED BIOPSY (VAB) SYSTEM
DEVICOR MEDICAL PRODUCTS, INC.    510(k) NO: K123259(TRADITIONAL)
ATTN: SHAWNA M ROSE               PHONE NO : 513 864 9178   
300 E-BUSINESS WAY, FIFTH FLOOR   SE DECISION MADE: 15-NOV-12
Cincinnati OH 45241               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: POWERPORT CLEARVUE SLIM IMPLANTABLE PORT
C.R. BARD, INC.                   510(k) NO: K122899(TRADITIONAL)
ATTN: AMY  HONEY                  PHONE NO : 801 522 5671   
605 NORTH 5600 WEST               SE DECISION MADE: 15-NOV-12
SALT LAKE CITY UT 84116           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NAVIGATION SOFTWARE HIP-UNIVERSAL; NAVIGATION SOFTWARE HIP THR-AESCULAP
BRAINLAB AG                       510(k) NO: K122011(TRADITIONAL)
ATTN: ALEXANDER  SCHWIERSCH       PHONE NO : 498 999 15680
KAPELLENSTRASSE 12                SE DECISION MADE: 15-NOV-12
FELDKIRCHEN    GM 85622           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE, WHITE AND GREEN COLORED. NON-STERILE, LOW DERMATITIS POTENTIAL
KOSSAN LATEX INDUSTRIES(M)SDN BHD 510(k) NO: K120066(TRADITIONAL)
ATTN: CHO S FONG                  PHONE NO : 603 339 27616
LOT 6129,JALAN HAJI ABDUL MANAN, OSE DECISION MADE: 16-NOV-12
KLANG, SELANGOR D.E.    MY 41050  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STEREOS WORKSTATION
EOS IMAGING                       510(k) NO: K113344(TRADITIONAL)
ATTN: JOHN J SMITH                PHONE NO : 202 637 3638   
555 THIRTEENTH STREET, NW         SE DECISION MADE: 16-NOV-12
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOSSEOUS DENTAL IMPLANT
OT MEDICAL GMBH                   510(k) NO: K113113(TRADITIONAL)
ATTN: SABINE  SCHMAHL             PHONE NO : 494 215 5716115
KONSUL-SMIDT-STR. 8B              SE DECISION MADE: 16-NOV-12
BREMEN    GM D-28217              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZIMMER UNICOMPARTMENTAL KNEE SYSTEM VIVACIT-E ARTICULAR SURFACE
ZIMMER, INC.                      510(k) NO: K122529(TRADITIONAL)
ATTN: MARK D WARNER               PHONE NO : 574 372 4150   
P.O. BOX 708                      SE DECISION MADE: 16-NOV-12
WARSAW IN 46581 0708              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PEDIATRIC POSITIONER PAD SET
GE HEALTHCARE COILS (USA INSTRUMEN510(k) NO: K122174(TRADITIONAL)
ATTN: MICHELLE  HUETTNER          PHONE NO : 262 521 6102   
1515 DANNER DR                    SE DECISION MADE: 16-NOV-12
AURORA OH 44202 9273              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPHYGMOCOR XCEL
ATCOR MEDICAL                     510(k) NO: K122129(TRADITIONAL)
ATTN: JOHN  ABRAM                 PHONE NO : 612 987 48761
11/1059-1063 VICTORIA ROAD        SE DECISION MADE: 16-NOV-12
WEST RYDE NSW    AS 2114          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEUVIZ 64 MULTI-SLICE CT SCANNER SYSTEM
NEUSOFT MEDICAL SYSTEMS CO., LTD. 510(k) NO: K121792(TRADITIONAL)
ATTN: CHARLES  MACK               PHONE NO : 931 625 4938   
77325 JOYCE WAY                   SE DECISION MADE: 16-NOV-12
ECHO OR 97826                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCU-CHEK ULTRAFLEX INFUSION SET
ROCHE DIABETES CARE AG            510(k) NO: K122686(SPECIAL)
ATTN: CATHERINE  GREEN            PHONE NO : 413 442 42272
KIRCHBERGSTRASSE 190              SE DECISION MADE: 16-NOV-12
BURGDORF    SZ CH-3401            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CENTRICITY PACS-IW WITH UNIVERSAL VIEWER
GE HEALTHCARE                     510(k) NO: K123174(SPECIAL)
ATTN: CHERYL  BORK                PHONE NO : 847 277 6038   
540 W. NORTHWEST HIGHWAY          SE DECISION MADE: 16-NOV-12
BARRINGTON IL 60010               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VARISOURSE IX BRAHYTHERAPY AFTERLOADER VARISOURCE IX (T) BRACHYTHERAPY AFTERLOADER
VARIAN MEDICAL SYSTEMS, INC.      510(k) NO: K122236(TRADITIONAL)
ATTN: VY  TRAN                    PHONE NO : 650 424 5731   
3100 HANSEN WAY                   SE DECISION MADE: 16-NOV-12
PALO ALTO CA 94304                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TEXTURED, BLUE, LATEX, POWDER FREE EXAMINATION GLVOES, WITH PROTEIN LABELING CLAIM (50UG/DM OR LESS OF WATER SOLUBLE PRO
NORTHSTAR HEALTHCARE HOLDINGS     510(k) NO: K123026(TRADITIONAL)
ATTN: ANTHONY  GIACCIO            PHONE NO : 815 385 0100
1202 SOUTH ROUTE 31               SE DECISION MADE: 16-NOV-12
MCHENRY    BD HM11                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ABL90 FLEX
RADIOMETER MEDICAL APS            510(k) NO: K122729(SPECIAL)
ATTN: MARTIN  GABLER              PHONE NO : 453 827 3114
AKANDEVEJ 21                      SE DECISION MADE: 16-NOV-12
BRONSHOJ    DA DK-2700            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MS SA IMPLANT SYSTEM
OSSTEM IMPLANT CO LTD             510(k) NO: K122171(TRADITIONAL)
ATTN: PATRICK  LIM                PHONE NO : 888 678 0001   
85 BEN FAIRLESS DR.               SE DECISION MADE: 16-NOV-12
FAIRLESS HILLS PA 19030           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRO-LINK CERVICAL SPACER SYSTEM
LIFE SPINE, INC                   510(k) NO: K121151(TRADITIONAL)
ATTN: RANDY  LEWIS                PHONE NO : 847 884 6117   
2401 W. HASSELL RD SUITE 1535     SE DECISION MADE: 16-NOV-12
HOFFMAN ESTATES IL 60169          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 360 GAS ASSISTED ENDOSCOPIC APPLICATOR
MICROMEDICS, INC.                 510(k) NO: K122526(SPECIAL)
ATTN: JODI L RAUS                 PHONE NO : 651 452 1977   
1270 EAGAN INDUSTRIAL ROAD SUITE 1SE DECISION MADE: 16-NOV-12
Saint Paul MN 55121               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CD HORIZON SPIRE Z SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK           510(k) NO: K123246(SPECIAL)
ATTN: JULIE  BASSETT              PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 16-NOV-12
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE
INCITE INNOVATION LLC             510(k) NO: K122008(TRADITIONAL)
ATTN: JOHN  KIRWAN                PHONE NO : 413 382 0212   
1500 MAIN STREET STE. 2410        SE DECISION MADE: 16-NOV-12
SPRINGFIELD MA 01115              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HAMILTON-C2
HAMILTON MEDICAL AG               510(k) NO: K121225(TRADITIONAL)
ATTN: RALPH  AGUILA               PHONE NO : 419 166 06845
VIA CRUSCH 8                      SE DECISION MADE: 16-NOV-12
BONADUZ    SZ CH-7402             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM
SYNTHES INC                       510(k) NO: K113567(TRADITIONAL)
ATTN: ALAN T HALEY                PHONE NO : 484 356 9763   
1301 GOSHEN PARKWAY               SE DECISION MADE: 19-NOV-12
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALIVECOR HEART MONITOR FOR IPHONE
ALIVECOR, INC.                    510(k) NO: K122356(TRADITIONAL)
ATTN: MICHAEL  RIGHTER            PHONE NO : 415 347 2212   
140 GEARY STREET SUITE 500        SE DECISION MADE: 19-NOV-12
SAN FRANCISCO CA 94108            510(k) STATEMENT

DEVICE: PTFE SUPER SHEATH INTRODUCER
MARTECH MEDICAL PRODUCTS          510(k) NO: K120617(TRADITIONAL)
ATTN: ALEXIS  ERAZO               PHONE NO : 215 256 4201   
1500 DELP DR.                     SE DECISION MADE: 19-NOV-12
HARLEYSVILLE PA 19438 2900        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SENTRYSUITE PRODUCT LINE
CAREFUSION GERMANY 234 GMBH       510(k) NO: K122699(TRADITIONAL)
ATTN: ELMAR  NIEDERMEYER          PHONE NO : 499 314 972361
LEIBNIZSTRASSE 7                  SE DECISION MADE: 19-NOV-12
HOECHBERG    GM 97204             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RESTORELLE L
COLOPLAST CORP.                   510(k) NO: K122440(TRADITIONAL)
ATTN: TIM  CRABTREE               PHONE NO : 612 302 4922   
1601 WEST RIVER RD NORTH          SE DECISION MADE: 19-NOV-12
MINNEAPOLIS MN 55411              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITEK 2 AST STREPTOCOCUS VANCOMYCIN
BIOMERIEUX, INC.                  510(k) NO: K121100(TRADITIONAL)
ATTN: JOCELYN  JENNINGS           PHONE NO : 919 620 2894   
595 ANGLUM RD.                    SE DECISION MADE: 19-NOV-12
HAZELWOOD MO 63042                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZOU ANTERIOR LUMBAR PLATE SYSTEM
CORELINK LLC                      510(k) NO: K121791(TRADITIONAL)
ATTN: JUSTIN  EGGLETON            PHONE NO : 202 552 5800   
1331 H STREET 12TH FLOOR          SE DECISION MADE: 19-NOV-12
WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LOQTEQ DISTAL LATERAL FEMUR PLATE 4.5 (LEFT AND RIGHT VERSION) LOQREQ CORTICAL SCREW 4.5 T25, SELF-TAPPING
AAP IMPLANTATE AG                 510(k) NO: K121494(TRADITIONAL)
ATTN: MARC  SEEGERS               PHONE NO : 004 930750 19192
LORENZWEG 5                       SE DECISION MADE: 19-NOV-12
BERLIN    GM 12099                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NON-CONTACT THERMOMETER
K-JUMP HEALTH CO., LTD.           510(k) NO: K120711(TRADITIONAL)
ATTN: JM  LIN                     PHONE NO : 886 222 991378
NO. 56, WU KUNG 5TH RD., NEW TAIPESE DECISION MADE: 19-NOV-12
NEW TAIPEI CITY    TW 248         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MOBILECARE MONITOR
AFRAME DIGITAL, INC.              510(k) NO: K122333(TRADITIONAL)
ATTN: JILL  THORPE                PHONE NO : 571 308 0152   
1889 Preston White Drive Suite 101SE DECISION MADE: 19-NOV-12
Reston VA 20191                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACUMED PELVIC BONE PLATE SYSTEM
ACUMED LLC                        510(k) NO: K122538(TRADITIONAL)
ATTN: KARA  BUDOR                 PHONE NO : 503 207 1412   
5885 NW Cornelius Pass Rd         SE DECISION MADE: 19-NOV-12
HILLSBORO OR 97124                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RUMBLE TUFF
ACUTE IDEAS CO. LTD.              510(k) NO: K113315(TRADITIONAL)
ATTN: MATTHEW  KHO                PHONE NO : 801 609 8168   
865 N 1430 W                      SE DECISION MADE: 20-NOV-12
OREM UT 84057                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COMPRESS SEGMENTAL HUMERAL REPLACEMENT SYSTEM
BIOMET MANUFACTUTING CORP.        510(k) NO: K123297(SPECIAL)
ATTN: PATRICIA  BERES             PHONE NO : 574 267 6639   
56 EAST BELL DRIVE                SE DECISION MADE: 20-NOV-12
WARSAW IN 46581                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CDI BLOOD PARAMETER MONITORING SYSTEM 500
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K123039(TRADITIONAL)
ATTN: KEVIN  KONG                 PHONE NO : 734 663 4145   
6200 JACKSON RD.                  SE DECISION MADE: 20-NOV-12
ANN ARBOR MI 48103                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMIGO REMOTE CATHETER SYSTEM & ACCESSORIES
CATHETER ROBOTICS INC             510(k) NO: K122488(TRADITIONAL)
ATTN: JENNIFER  ENGLUND           PHONE NO : 973 691 2000   
500 INTERNATIONAL DRIVE           SE DECISION MADE: 20-NOV-12
MOUNT OLIVE NJ 07828              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
SURGICAL SPECIALTIES CORP. DBA ANG510(k) NO: K123409(TRADITIONAL)
ATTN: KIRSTEN  STOWELL            PHONE NO : 610 404 3367   
100 DENNIS DR.                    SE DECISION MADE: 20-NOV-12
Reading PA 19606                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZOLL RESCUENET 12-LEAD
ZOLL MEDICAL CORPORATION          510(k) NO: K121865(TRADITIONAL)
ATTN: CHARLES W KOLIFRATH         PHONE NO : 978 421 9786   
269 MILL ROAD                     SE DECISION MADE: 20-NOV-12
CHELMSFORD MA 01824               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HET BIPOLAR LIGATOR SYSTEM
HET SYSTEMS, LLC                  510(k) NO: K121085(TRADITIONAL)
ATTN: SHELLEY  TRIMM              PHONE NO : 707 508 5527   
1152 NAVARRO ST, STE 2001         SE DECISION MADE: 20-NOV-12
SANTA ROSA CA 95401               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATING
W. L. GORE & ASSOCIATES, INC.     510(k) NO: K121234(TRADITIONAL)
ATTN: ALICIA L HEMPHILL           PHONE NO : 928 864 4328   
3450  KILTIE LANE P.O. BOX 2400   SE DECISION MADE: 20-NOV-12
FLAGSTAFF AZ 86003 2400           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REMOTE PRESENCE SYSTEM, MODEL RP-VITA
INTOUCH HEALTH, INC.              510(k) NO: K123229(TRADITIONAL)
ATTN: STEVE  SIDWELL              PHONE NO : 805 562 8686   
6330 HOLLISTER AVE.               SE DECISION MADE: 20-NOV-12
GOLETA CA 93117                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITEK 2 GRAM NEGATIVE DOXYCYCLINE
BIOMERIEUX, INC.                  510(k) NO: K121546(TRADITIONAL)
ATTN: JENNIFER  CHIA-HSUAN LIN    PHONE NO : 314 731 8639   
595 ANGLUM RD.                    SE DECISION MADE: 20-NOV-12
HAZELWOOD MO 63042                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PENUMBRA DDC CATHETERS
PENUMBRA, INC.                    510(k) NO: K122772(TRADITIONAL)
ATTN: SETH  SCHULMAN              PHONE NO : 510 748 3247   
1351 Harbor Bay Parkway           SE DECISION MADE: 20-NOV-12
Alameda CA 94502                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3
RANDOX LABORATORIES, LTD.         510(k) NO: K121603(TRADITIONAL)
ATTN: PAULINE  ARMSTRONG          PHONE NO : 440 289 4422413
55 DIAMOND RD.                    SE DECISION MADE: 20-NOV-12
CRUMLIN, COUNTY ANTRIM    UK BT29 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PHT-6500; PHT-60CFO; PAX-I3D
MTECH GROUP                       510(k) NO: K122606(SPECIAL)
ATTN: DAVE  KIM                   PHONE NO : 713 467 2607   
12946 KIMBERLEY LN                SE DECISION MADE: 20-NOV-12
HOUSTON TX 77079                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM
PLASMA SURGICAL LIMITED           510(k) NO: K121977(TRADITIONAL)
ATTN: PETER  GIBSON               PHONE NO : 44 1235 822506
127 MILTON PARK                   SE DECISION MADE: 20-NOV-12
ABINGDON, OXFORDSHIRE    UK OX14 4510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THERMOFORMED MOUTHGUARDS
GLIDEWELL LABORATORIES-SLEEP DEVIC510(k) NO: K121365(TRADITIONAL)
ATTN: ARMIN  ZEHTABCHI            PHONE NO : 949 399 1940   
2181 DUPONT DR.                   SE DECISION MADE: 20-NOV-12
IRVINE CA 92612                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION
FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K122454(TRADITIONAL)
ATTN: DEBBIE  PEACOCK             PHONE NO : 203 602 3774   
419 WEST AVE.                     SE DECISION MADE: 20-NOV-12
STAMFORD CT 06902 6300            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 3M TRUE DEFINITION SCANNER
3M COMPANY                        510(k) NO: K122467(TRADITIONAL)
ATTN: GINGER  CANTOR              PHONE NO : 651 733 1317   
2510 CONWAY AVENUE                SE DECISION MADE: 20-NOV-12
ST. PAUL MN 55144                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: UFIT TEN-10
BIOSIGN TECHNOLOGIES, INC.        510(k) NO: K122443(ABBREVIATED)
ATTN: ALLISON  SCOTT, RAC         PHONE NO : 317 569 9500   
9001 WESLEYAN RD, SUITE 200       SE DECISION MADE: 20-NOV-12
INDIANAPOLIS IN 46268             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEALTHMATEFOREVER
HEALTHMATE INTERNATIONAL, LLC     510(k) NO: K121757(TRADITIONAL)
ATTN: MEI  DODSON                 PHONE NO : 816 248 1318   
709 E. 97TH STREET                SE DECISION MADE: 20-NOV-12
KANSAS CITY MO 64131              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: S-LOK PSS SYSTEM
SPINAL USA                        510(k) NO: K122931(TRADITIONAL)
ATTN: J.D.  WEBB                  PHONE NO : 512 388 0199   
1001 OAKWOOD BLVD                 SE DECISION MADE: 20-NOV-12
ROUND ROCK TX 78681               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 2 MODEL 272, LIQUICHEK ETHA
BIO-RAD LABORATORIES              510(k) NO: K123198(TRADITIONAL)
ATTN: SUZANNE  PARSONS            PHONE NO : 949 598 1467   
9500 JERONIMO RD.                 SE DECISION MADE: 20-NOV-12
IRVINE CA 92618 2017              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTHROSCOPIC SURGICAL INSTRUMENTS - INTERFERENCE SCREW SYSTEMS
SMITH & NEPHEW, INC.              510(k) NO: K122596(TRADITIONAL)
ATTN: SEAN  REYNOLDS              PHONE NO : 978 749 1173   
150 MINUTEMAN RD.                 SE DECISION MADE: 20-NOV-12
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VICEROY SPINAL SYSTEM
TORREY SPINE                      510(k) NO: K122229(TRADITIONAL)
ATTN: MEREDITH  MAY               PHONE NO : 719 337 7579   
4628 NORTHPARK DRIVE              SE DECISION MADE: 20-NOV-12
COLORADO SPRINGS CO 80918         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT
EXACTECH, INC.                    510(k) NO: K121220(SPECIAL)
ATTN: LINDY  KNISELY              PHONE NO : 352 377 1140   
2320 N.W. 66TH CT.                SE DECISION MADE: 20-NOV-12
GAINESVILLE FL 32653              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONTIPLEX C CONTINUOUS PERIPHERAL NERVE BLOCK NEEDLE
B. BRAUN MEDICAL, INC.            510(k) NO: K121846(TRADITIONAL)
ATTN: NANCY  SKOCYPEC             PHONE NO : 610 596 2796   
901 MARCON BLVD.                  SE DECISION MADE: 20-NOV-12
ALLENTOWN PA 18109 9341           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM
FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K121499(TRADITIONAL)
ATTN: KATHERINE Y CHOI            PHONE NO : 203 602 3568   
419 WEST AVE.                     SE DECISION MADE: 20-NOV-12
STAMFORD CT 06902 6300            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HI-TORQUE COMMAND GUIDE WIRE FAMILY
ABBOTT VASCULAR INC.              510(k) NO: K122573(TRADITIONAL)
ATTN: KAY  SETZER                 PHONE NO : 951 914 3242   
26531 YNEZ ROAD, BUILDING G MALINGSE DECISION MADE: 20-NOV-12
TEMECULA CA 92590 9018            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNGO.VIA
SIEMENS AG                        510(k) NO: K123375(TRADITIONAL)
ATTN: SABINE  SCHROEDEL           PHONE NO : 49 9131 848285
HENKESTRASSE 127                  SE DECISION MADE: 20-NOV-12
ERLANGEN, BAVARIA    GM 91052     510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: AIRSTRIP RPM FOR LIFENET CONSULT
AIRSTRIP TECHNOLOGIES, INC.       510(k) NO: K121712(TRADITIONAL)
ATTN: ROBERT A MILLER             PHONE NO : 210 805 0444   
335 E Sonterra Blvd Ste 200       SE DECISION MADE: 20-NOV-12
SAN ANTONIO TX 78258              510(k) STATEMENT

DEVICE: AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE
RADIOMETER MEDICAL APS            510(k) NO: K120326(TRADITIONAL)
ATTN: OLE  SCHOU                  PHONE NO : 453 827 3617
AKANDEVEJ 21                      SE DECISION MADE: 21-NOV-12
BRONSHOJ    DA DK-2700            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SONICSTIMU COMBO THERAPEUTIC DEVICE
SHENZHEN DONGDIXIN TECHNOLOGY CO, 510(k) NO: K120217(TRADITIONAL)
ATTN: KANG JIAN  PING             PHONE NO : 867 552 7652471
NO. 3 BUILDING XILIBAIMANG XUSHENGSE DECISION MADE: 21-NOV-12
SHENZHEN    CH 518108             510(k) STATEMENT

DEVICE: HEMASORB APPLY
ORTHOCON, INC.                    510(k) NO: K121953(SPECIAL)
ATTN: RICHARD  KRONENTHAL, PHD    PHONE NO : 914 357 2641   
1 Bridge St Ste 121               SE DECISION MADE: 21-NOV-12
Irvington NY 10533                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWERPLAY MUSCLE MASSAGER
FIG, LLC                          510(k) NO: K122154(TRADITIONAL)
ATTN: JOE  ADKINS                 PHONE NO : 216 849 7847   
2839 HARVEST MOON DRIVE           SE DECISION MADE: 21-NOV-12
ORANGE PARK FL 32073              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: .DECIMAL PHOTON BLOCK
.DECIMAL, INC.                    510(k) NO: K123015(TRADITIONAL)
ATTN: KYM  RUPP                   PHONE NO : 407 330 3300   
121 CENTRAL PARK PLACE            SE DECISION MADE: 21-NOV-12
SANFORD FL 32771                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CORIN TRINITY-I ACETABULAR SHELL
CORIN USA                         510(k) NO: K122305(TRADITIONAL)
ATTN: DIANA L MARTONE             PHONE NO : 813 977 4469   
10500 UNIVERSITY CENTER DRIVE SUITSE DECISION MADE: 21-NOV-12
TAMPA FL 33612                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VECTTOR VT-200
ALAN NEUROMEDICAL TECHNOLOGIES LLC510(k) NO: K121662(ABBREVIATED)
ATTN: DONALD A RHODES             PHONE NO : 361 992 9432   
6001-B S. STAPLES ST              SE DECISION MADE: 21-NOV-12
CORPUS CHRISTI TX 78413           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STR GRAFT
SOFT TISSUE REGENERATION, INC.    510(k) NO: K121216(TRADITIONAL)
ATTN: ROBERT A POGGIE             PHONE NO : 973 738 6097   
815 IRIS LANE                     SE DECISION MADE: 21-NOV-12
VERO BEACH FL 32963               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PLANMED NUANCE DIGIGUIDE
PLANMED OY                        510(k) NO: K121963(TRADITIONAL)
ATTN: LARS  MORING                PHONE NO : 358 207 795300
ASENTAJANKATU 6 SORVAAJANKATU 7   SE DECISION MADE: 21-NOV-12
HELSINKI    FI FI-00880           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 90254
CONCENTRIC MEDICAL, INC.          510(k) NO: K122581(TRADITIONAL)
ATTN: CHRISTINA  ROWE             PHONE NO : 510 413 2486   
301 E Evelyn Ave                  SE DECISION MADE: 21-NOV-12
MOUNTAIN VIEW CA 94041            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM
ACON LABORATORIES, INC.           510(k) NO: K122110(SPECIAL)
ATTN: QIYI  XIE                   PHONE NO : 858 525 8531   
10125 Mesa Rim Road               SE DECISION MADE: 21-NOV-12
SAN DIEGO CA 92121                510(k) STATEMENT

DEVICE: DIOWAVE LOW LEVEL COLD LASER SYSTEM
TECHNOLOGICAL MEDICAL ADVANCMENTS,510(k) NO: K121363(TRADITIONAL)
ATTN: BRUCE  COREN                PHONE NO : 866 862 6606   
1209 NORTH FLAGLER DRIVE          SE DECISION MADE: 23-NOV-12
WEST PALM BEACH FL 33401          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: G7 ACETABULAR SYSTEM
BIOMET MANUFACTURING CORP.        510(k) NO: K121874(TRADITIONAL)
ATTN: BECKY  EARL                 PHONE NO : 574 267 6639   
56 EAST BELL DRIVE P.O. BOX 587   SE DECISION MADE: 23-NOV-12
WARSAW IN 46581 0587              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KITAZATO OPU NEEDLE
KITAZATO MEDICAL CO., LTD.        510(k) NO: K112462(TRADITIONAL)
ATTN: RICHARD  VINCINS            PHONE NO : 512 327 9997   
611 WEST 5TH STREET               SE DECISION MADE: 26-NOV-12
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PICCOLO COMPOSITE PLATE SYSTEM
CARBOFIX ORTHOPEDICS LTD.         510(k) NO: K120409(TRADITIONAL)
ATTN: YAEL  RUBIN                 PHONE NO : 972 995 11511
11 HA'HOSHLIM STREET              SE DECISION MADE: 26-NOV-12
HERZELIYA    IS 46724             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POLARIS DIAL-A-DATE CONTACT LENS CASE
RELIANCE DESIGN & MANUFACTURE CORP510(k) NO: K120904(TRADITIONAL)
ATTN: CAROLINE  TONTINI           PHONE NO : 512 327 9997   
611 WEST FIFTH STREET THRID FLOOR SE DECISION MADE: 26-NOV-12
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CUROS TIP
IVERA MEDICAL, INC.               510(k) NO: K121171(TRADITIONAL)
ATTN: DON  CANAL                  PHONE NO : 888 861 8228   
2731 LOKER AVENUE WEST            SE DECISION MADE: 26-NOV-12
CARLSBAD CA 92010                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SENSUS ELECTRODE
NEUROMETRIX, INC.                 510(k) NO: K121816(TRADITIONAL)
ATTN: RAINER  MAAS                PHONE NO : 781 890 9989   
62 FOURTH AVE.                    SE DECISION MADE: 26-NOV-12
Waltham MA 02451                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STABILIZ FIXATION SYSTEM
STABILIZ ORTHOPAEDICS, LLC        510(k) NO: K120651(TRADITIONAL)
ATTN: DOUGLAS L CERYNIK, MD       PHONE NO : 973 714 5985   
3225 ARCH ST                      SE DECISION MADE: 27-NOV-12
PHILADELPHIA PA 19104             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000
DXM CO., LTD.                     510(k) NO: K121093(ABBREVIATED)
ATTN: JIGAR  SHAH                 PHONE NO : 516 482 9001   
55 NORTHERN BLVD.                 SE DECISION MADE: 27-NOV-12
GREAT NECK NY 11021               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WATER BOTTLE CAP IRRIGATON SYSTEM
ENDOCHOICE, INC.                  510(k) NO: K120862(TRADITIONAL)
ATTN: THERON  GOBER               PHONE NO : 678 534 6021   
11810 Wills Road Suite 100        SE DECISION MADE: 27-NOV-12
Alpharetta GA 30009               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MERETE LOCKING BONE PLATE SYSTEM III
MERETE MEDICAL GMBH               510(k) NO: K120787(TRADITIONAL)
ATTN: DONNA  COLEMAN              PHONE NO : 914 967 1532   
99 PURCHASE STREET                SE DECISION MADE: 27-NOV-12
RYE NY 10580                      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ABBOTT ARCHITECT FREE T4
ABBOTT LABORATORIES               510(k) NO: K123379(SPECIAL)
ATTN: JACEK  GORZOWSKI            PHONE NO : 847 938 1740   
100 ABBOTT PARK RD.               SE DECISION MADE: 27-NOV-12
ABBOTT PARK IL 60064 3500         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN
CEREMED, INC.                     510(k) NO: K122561(TRADITIONAL)
ATTN: CHELSEA  MITCHELL           PHONE NO : 310 815 2125   
3643 LENAWEE AVE.                 SE DECISION MADE: 27-NOV-12
LOS ANGELES CA 90016              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PICOSURE WORKSTATION
CYNOSURE, INC.                    510(k) NO: K121346(TRADITIONAL)
ATTN: IRINA  KULINETS             PHONE NO : 978 256 4200   
5 CARLISLE ROAD                   SE DECISION MADE: 27-NOV-12
WESTFORD MA 01886                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TANDA PEARL, ULTRAWYTE, PEARL
SYNERON BEAUTY                    510(k) NO: K122725(TRADITIONAL)
ATTN: JANICE M HOGAN              PHONE NO : 267 675 4611   
1835 MARKET ST., 29TH FLOOR       SE DECISION MADE: 27-NOV-12
PHILADELPHIA PA 19103             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTICROSS SUPPORT CATHETER
ROXWOOD MEDICAL, INC.             510(k) NO: K121763(TRADITIONAL)
ATTN: MEHRDAD  FARHANGNIA         PHONE NO : 408 373 4751   
150 EXECUTIVE PARK BLVD, STE 3700 SE DECISION MADE: 27-NOV-12
SAN FRANCISCO CA 94134            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OPTECURE BONE VOID FILLER (0.5 CC, 1CC, 2CC, 5CC, 10CC, AND 20CC), OPTECURE + CCC BONE VOID FILLER (1CC, 2CC, 5CC, 10CC,
EXACTECH, INC.                    510(k) NO: K121989(TRADITIONAL)
ATTN: GINA  CASSIDY               PHONE NO : 352 377 1140   
2320 N.W. 66TH CT.                SE DECISION MADE: 27-NOV-12
GAINESVILLE FL 32653              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AZUR CX DETACHABLE 18
MICROVENTION, INC.                510(k) NO: K123384(SPECIAL)
ATTN: CYNTHIA  VALENZUELA         PHONE NO : 714 247 8053   
1311 VALENCIA AVE                 SE DECISION MADE: 28-NOV-12
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER
VITAL SIGNS, INC., A GE HEALTHCARE510(k) NO: K121775(SPECIAL)
ATTN: STACIE  GEFFNER-ATIYA       PHONE NO : 973 956 5491   
20 CAMPUS RD                      SE DECISION MADE: 28-NOV-12
TOTOWA NJ 07512                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ILLICO FS FACET FIXATION SYSTEM
ALPHATEC SPINE, INC.              510(k) NO: K123218(SPECIAL)
ATTN: TREVOR  DENBO               PHONE NO : 760 494 6951   
5830 El Camino Real               SE DECISION MADE: 28-NOV-12
Carlsbad CA 92008                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HYDROXY VITAMIN D EIA CALIBRATOR SET DIA
DIAZYME LABORATORIES              510(k) NO: K122420(TRADITIONAL)
ATTN: ABHIJIT  DATTA              PHONE NO : 858 455 4762   
12889 GREGG COURT                 SE DECISION MADE: 28-NOV-12
POWAY CA 92064                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUAL
OBJECT RESEARCH SYSTEMS (ORS) INC.510(k) NO: K122429(TRADITIONAL)
ATTN: ERIC F OURNIER              PHONE NO : 514 843 3861
760 St-Paul west suite 101        SE DECISION MADE: 28-NOV-12
Montreal    CA H3C1M4             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: SEAL ONE
PEROUSE MEDICAL                   510(k) NO: K123035(TRADITIONAL)
ATTN: CAROLINE  DAURELLE          PHONE NO : 300 41 60911
135, ROUTE NEUVE                  SE DECISION MADE: 28-NOV-12
IRIGNY    FR 69 540               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35
MICROVENTION, INC.                510(k) NO: K122543(TRADITIONAL)
ATTN: LARAINE  PANGELINA          PHONE NO : 714 247 8000   
1311 VALENCIA AVE                 SE DECISION MADE: 28-NOV-12
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PERKINELMER XRD 1622 AP3 MED FLAT PANEL DETECTOR
PERKINELMER, INC.                 510(k) NO: K122495(TRADITIONAL)
ATTN: KAY A TAYLOR                PHONE NO : 317 418 1735   
8275 CARLOWAY ROAD                SE DECISION MADE: 28-NOV-12
INDIANAPOLIS IN 46236             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MINIFIX BALL MINIFIX ONE
BONAFIX SURGICAL AND DENTAL IMPLAN510(k) NO: K122052(TRADITIONAL)
ATTN: JUAN  TEZAK                 PHONE NO : 561 789 2411   
118 W. PRIVE CR.                  SE DECISION MADE: 28-NOV-12
DELRAY BEACH FL 33445             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BLIP MODEL BP-700WF
CAREMATIX INC.                    510(k) NO: K123020(SPECIAL)
ATTN: SUKHWANT  KHANUJA           PHONE NO : 312 627 9300   
209 W. JACKSON BLVD. SUITE 800    SE DECISION MADE: 28-NOV-12
CHICAGO IL 60606                  510(k) STATEMENT

DEVICE: CERARESIN BOND
SHOFU DENTAL CORPORATION          510(k) NO: K123119(TRADITIONAL)
ATTN: DAVID P MORAIS              PHONE NO : 760 736 3277   
1225 STONE DRIVE                  SE DECISION MADE: 28-NOV-12
SAN MARCOS CA 92078               510(k) STATEMENT

DEVICE: TXCELL SCANNING LASER DELIVERY SYSTEM
IRIDEX CORP.                      510(k) NO: K121475(TRADITIONAL)
ATTN: PAUL H HARDIMAN             PHONE NO : 650 962 8848   
1212 Terra Bella Ave              SE DECISION MADE: 28-NOV-12
MOUNTAIN VIEW CA 94043            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SJM CONFIRM
ST. JUDE MEDICAL                  510(k) NO: K122161(TRADITIONAL)
ATTN: SAKET  BHATT                PHONE NO : 408 522 6832   
701 EAST EVELYN AVENUE            SE DECISION MADE: 28-NOV-12
SUNNYVALE CA 94086 6527           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CHECKMATE SMALL BONE FUSION SYSTEM
ARTHROSURFACE, INC.               510(k) NO: K122334(TRADITIONAL)
ATTN: DAWN J WILSON               PHONE NO : 508 520 3003   
28 FORGE PARKWAY                  SE DECISION MADE: 28-NOV-12
FRANKLIN MA 02038                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTS
CHEMTRON BIOTECH, INC.            510(k) NO: K123080(TRADITIONAL)
ATTN: JANE  ZHANG                 PHONE NO : 858 530 2868   
8370 JUNIPER CREEK LANE SUITE 1-2 SE DECISION MADE: 29-NOV-12
SAN DIEGO CA 92126                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICROSTREAM FILTERLINE ICU
ORIDION MEDICAL 1987 LTD.         510(k) NO: K121927(TRADITIONAL)
ATTN: DALIA  GIVONY               PHONE NO : 972 2 5899235
7 HAMARPE ST. P.O. BOX 45025 HAR HSE DECISION MADE: 29-NOV-12
JERUSALEM    IS 91450             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIGHTSCALPEL
LIGHTSCALPEL LLC                  510(k) NO: K123037(TRADITIONAL)
ATTN: DAVID  WALTERS              PHONE NO : 425 368 1588   
16932 Woodinville Redmond Rd NE StSE DECISION MADE: 29-NOV-12
Woodinville WA 98072              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PLANER BT37 INCUBATOR
PLANER PLC                        510(k) NO: K121566(TRADITIONAL)
ATTN: ERIC  GRUFF                 PHONE NO : 858 735 0320   
15696 OAKSTAND ROAD               SE DECISION MADE: 29-NOV-12
POWAY CA 92064 3389               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TS FIXTURE SYSTEM
OSSTEM IMPLANT CO.,LTD            510(k) NO: K121995(TRADITIONAL)
ATTN: PATRICK  LIM                PHONE NO : 888 678 0001   
85 BEN FAIRLESS DR.               SE DECISION MADE: 29-NOV-12
FAIRLESS HILLS PA 19030           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRIMALIF TM LLIF UNITARY PEEK LATERAL LUMBAR INTERBODY FUSION SYSTEM
OSTEOMED LP                       510(k) NO: K123207(TRADITIONAL)
ATTN: PIEDAD  PENA                PHONE NO : 972 677 4784   
3885 Arapaho Rd                   SE DECISION MADE: 29-NOV-12
ADDISON TX 75001                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONSTRUX MINI PEEK TI SPACER SYSTEM
ORTHOFIX                          510(k) NO: K121649(TRADITIONAL)
ATTN: NATALIA  VOLOSEN            PHONE NO : 214 937 2000   
3451 PLANO PARKWAY                SE DECISION MADE: 29-NOV-12
LEWISVILLE TX 75056               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TITAN
INTERACOUSTICS A/S                510(k) NO: K121847(TRADITIONAL)
ATTN: ERIK  NIELSEN               PHONE NO : 456 371 3555
DREJERVAENGET 8                   SE DECISION MADE: 29-NOV-12
ASSENS    DA DK-5610              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARROW JUGULAR AXILLO-SUBCLAVIAN CENTRAL CATHETER (JACC)
ARROW INTERNATIONAL(SUBSIDIARY OF 510(k) NO: K121501(TRADITIONAL)
ATTN: JULIE  LAWSON               PHONE NO : 610 378 0131   
2400 BERNVILLE RD.                SE DECISION MADE: 29-NOV-12
READING PA 19605                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160
ROCHE DIAGNOSTICS                 510(k) NO: K122722(TRADITIONAL)
ATTN: LISA K KLINEDINST           PHONE NO : 317 521 1942   
9115 HAGUE ROAD                   SE DECISION MADE: 29-NOV-12
INDIANAPOLIS IN 46250 0416        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)
GEENLI PLASTIC CO, LTD            510(k) NO: K122893(TRADITIONAL)
ATTN: CHU  XIAOAN                 PHONE NO : 861 082387 441
ROOM 1606 BLDG.1 JIANXIANG YUAN NOSE DECISION MADE: 30-NOV-12
BEIJING    CH 100083              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UCP HOME DRUG SCREENING TEST CUPS
UCP BIOSCIENCES, INC.             510(k) NO: K122419(TRADITIONAL)
ATTN: NANCY  CHEN                 PHONE NO : 408 392 0064   
1445 KOLL CIRCLE, STE. 111        SE DECISION MADE: 30-NOV-12
SAN JOSE CA 95112                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CURALINE POLYURETHANE FOAM AWC DRESSING
CURALINE INC                      510(k) NO: K121361(TRADITIONAL)
ATTN: HAITHAM  MATLOUB            PHONE NO : 262 422 7432   
10554 NORTH WASHINGTON PORT ROAD  SE DECISION MADE: 30-NOV-12
MEQUON WI 53092                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HARD SHELL VENTED NASAL MASK
SLEEPNET CORPORATION              510(k) NO: K121321(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DRIVE              SE DECISION MADE: 30-NOV-12
BONITA SPRINGS FL 34134 2958      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TARGET DETACHABLE COIL
STRYKER NEUROVASCULAR             510(k) NO: K123377(SPECIAL)
ATTN: RHODA  SANTOS               PHONE NO : 510 413 2269   
47900 Bayside Parkway             SE DECISION MADE: 30-NOV-12
Fremont CA 94538 6515             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOLITAIRE 2 REVASCULARIZATION DEVICE
MICRO THERAPEUTICS DBA EV3 NEUROVA510(k) NO: K123378(SPECIAL)
ATTN: LARRY  BOUCHER              PHONE NO : 949 297 9781   
9775 TOLEDO WAY                   SE DECISION MADE: 30-NOV-12
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
TOP GLOVE SDN. BHD.               510(k) NO: K122999(TRADITIONAL)
ATTN: EDDY  ROSAYDIE              PHONE NO : 603 33 921992
LOT 4968, BATU 6,JALAN TERATAI OFFSE DECISION MADE: 30-NOV-12
KLANG, SELANGOR    MY 41050       510(k) STATEMENT

DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
HEBEI LEADER PLASTIC CO., LTD     510(k) NO: K122920(TRADITIONAL)
ATTN: CHU  XIAOAN                 PHONE NO : 86 10 82387441
ROOM 1606 BLDG. 1. JIANXIANG YUAN SE DECISION MADE: 30-NOV-12
BEIJING    CH 100083              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NAVIOPFS
BLUE BELT TECHNOLOGIES, INC.      510(k) NO: K121936(TRADITIONAL)
ATTN: RICHARD G CONFER            PHONE NO : 412 683 3844   
2828 LIBERTY AVENUE SUITE 100     SE DECISION MADE: 30-NOV-12
PITTSBURGH PA 15222               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HYLATOPICPLUS LOTION
PRECISION DERMATOLOGY INCORPORATED510(k) NO: K121559(SPECIAL)
ATTN: RONALD M GURGE              PHONE NO : 401 762 2000   
900 HIGHLAND CORPORATE DRIVE      SE DECISION MADE: 30-NOV-12
CUMBERLAND RI 02864               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K121994(TRADITIONAL)
ATTN: A. KATHLEEN B ENNIS         PHONE NO : 302 631 9352   
500 GBC DRIVE                     SE DECISION MADE: 30-NOV-12
NEWARK DE 19714                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR
MICROSULIS MEDICAL LIMITED        510(k) NO: K122762(TRADITIONAL)
ATTN: STUART  MCINTYRE            PHONE NO : 442 392 240011
UNIT 1 AND 2 FALSON COURT PARKLANDSE DECISION MADE: 30-NOV-12
DENMEAD    UK PO7 7XP             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMARTTOOLS KNEE SYSTEM
ZIMMER                            510(k) NO: K122326(TRADITIONAL)
ATTN: CHRISTOPHER  MCLEAN         PHONE NO : 514 861 4074
75, QUEEN STREET SUITE 3300       SE DECISION MADE: 30-NOV-12
MONTREAL    CA H3C 2N6            510(k) SUMMARY AVAILABLE FROM FDA


                                                 TOTAL 510(k)s THIS PERIOD   225                                     
                                                 TOTAL WITH SUMMARIES        213                                     
                                                 TOTAL WITH STATEMENTS        12