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
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