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U.S. Department of Health and Human Services

Medical Devices

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September 2012 510(k) Clearances

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


DEVICE: ORTHOFIX GALAXY FIXATION SYSTEM
ORTHOFIX SRL                      510(k) NO: K113770(TRADITIONAL)
ATTN: CANDACE F CEDERMAN          PHONE NO : 503 722 7494   
15058 ARMEL DR.                   SE DECISION MADE: 04-SEP-12
OREGON CITY OR 97045              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TENS BACK PAIN RELIEF SYSTEM
SAVIA LIMITED                     510(k) NO: K113321(TRADITIONAL)
ATTN: GUENTER  GINSBERG           PHONE NO : 239 948 2001   
11820 RED HIBISCUS                SE DECISION MADE: 04-SEP-12
BONITA SPRINGS FL 34135           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IOI TOTAL HIP
ICONACY ORTHOPEDIC IMPLANTS, LLC  510(k) NO: K121034(TRADITIONAL)
ATTN: ROY Y HORI, PHD             PHONE NO : 574 269 4622   
PO BOX 1033                       SE DECISION MADE: 04-SEP-12
WARSAW IN 46581 1033              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CVINSIGHT
INTELOMED, INC                    510(k) NO: K120052(TRADITIONAL)
ATTN: JAN  BERKOW                 PHONE NO : 412 213 3251   
4284 LAMPL LN                     SE DECISION MADE: 04-SEP-12
ALLISON PARK PA 15101             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
VATECH CO., LTD.                  510(k) NO: K122155(SPECIAL)
ATTN: DAVE  KIM                   PHONE NO : 713 467 2607   
12946 KIMBERLEY LN                SE DECISION MADE: 04-SEP-12
HOUSTON TX 77079                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARC ENDOCUFF
BODDINGTONS PLASTICS LTD          510(k) NO: K122565(TRADITIONAL)
ATTN: JOHN  BOVIS                 PHONE NO : 440 1622 833700
UNIT 6 WHEELBARROW PARK ESTATE PATSE DECISION MADE: 04-SEP-12
TONBRIDGE, KENT    UK TN12 9QL    510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES
MAUNA KEA TECHNOLOGIES            510(k) NO: K122042(TRADITIONAL)
ATTN: MICHAEL  DANIEL             PHONE NO : 415 407 0223   
8 SNOWBERRY COURT                 SE DECISION MADE: 04-SEP-12
ORINDA CA 94563                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALAMO P
ALLIANCE PARTNERS, LLC            510(k) NO: K122047(TRADITIONAL)
ATTN: JENNIFER  PALINCHIK         PHONE NO : 440 933 8850   
33490 PIN OAK PARKWAY             SE DECISION MADE: 04-SEP-12
AVON LAKE OH 44012                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TEST, BLOOD GLUCOSE SYSTEM
HMD BIOMEDICAL, INC.              510(k) NO: K120064(TRADITIONAL)
ATTN: JESSICA  TUNG               PHONE NO : 886 360 17000
NO 181, MINGSHENG ST              SE DECISION MADE: 05-SEP-12
XINPU TOWNSHIP, HSINCHU COUNTY    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER
COVIDIEN, FORMERLY VALLEYLAB, A DI510(k) NO: K113572(TRADITIONAL)
ATTN: JOHN VAN  HOVEN             PHONE NO : 303 476 7502   
5920 LONGBOW DR.                  SE DECISION MADE: 05-SEP-12
BOULDER CO 80301                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TIXOS IMPLANT SYSTEM
LEADER ITALIA S.R.L.              510(k) NO: K120792(TRADITIONAL)
ATTN: STUART R GOLDMAN            PHONE NO : 512 327 9998   
611 WEST 5TH ST, THIRD FLOOR      SE DECISION MADE: 05-SEP-12
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: METS SMILES TOTAL KNEE REPLACEMENT
STANMORE IMPLANTS WORLDWIDE LTD   510(k) NO: K120992(TRADITIONAL)
ATTN: NANCY C MACDONALD           PHONE NO : 781 329 2993   
690 CANTON STREET SUITE 302       SE DECISION MADE: 05-SEP-12
WESTWOOD MA 02090                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOHORIZONS TAPERED INTERNAL PLUS IMPLANTS
BIOHORIZONS IMPLANT SYSTEMS, INC. 510(k) NO: K121787(SPECIAL)
ATTN: MICHAEL  DAVIS              PHONE NO : 205 967 7880   
2300 RIVERCHASE CENTER            SE DECISION MADE: 05-SEP-12
BIRMINGHAM AL 35244               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON DILATATION CATHETER - 4MM X 19MM X 135CM
OSTIAL CORPORATION                510(k) NO: K122379(SPECIAL)
ATTN: KAITLIN VON  HOFFMANN       PHONE NO : 650 903 9100   
510 CLYDE AVENUE                  SE DECISION MADE: 05-SEP-12
MOUNTAIN VIEW CA 94043            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEOSS PROACTIVE TAPERED IMPLANT
NEOSS LTD                         510(k) NO: K113376(TRADITIONAL)
ATTN: CHERITA  JAMES              PHONE NO : 703 563 9800   
901 KING STREET SUITE 200         SE DECISION MADE: 05-SEP-12
ALEXANDRIA VA 22314               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON
DEGANIA SILICONE, LTD.            510(k) NO: K122030(TRADITIONAL)
ATTN: ZOYA  LEE                   PHONE NO : 972 467 55122
KIBBUTZ DEGANIA BET               SE DECISION MADE: 05-SEP-12
EMEK HAYARDEN    IS 15130         510(k) STATEMENT

DEVICE: MOLLRING MULTITASC
LEMAITRE VASCULAR, INC.           510(k) NO: K121415(TRADITIONAL)
ATTN: ANDREW  HODGKINSON          PHONE NO : 781 221 2266   
63 2ND AVENUE                     SE DECISION MADE: 05-SEP-12
BEDFORD MA 01803                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UGEO G60 DIAGNOSTIC ULTRASOUND SYSTEM
SAMSUNG MEDISON CO., LTD          510(k) NO: K122583(TRADITIONAL)
ATTN:                             PHONE NO : 
42, TEHERAN-RO 108-GIL GANGNAM-GU SE DECISION MADE: 05-SEP-12
SEOUL    KS                       510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS)
MEDICAL COMPONENTS INC            510(k) NO: K121383(TRADITIONAL)
ATTN: JEAN  CALLOW                PHONE NO : 215 256 4201   
1499 DELP DRIVE                   SE DECISION MADE: 05-SEP-12
HARLEYSVILLE PA 19438             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RELIANCE ANTERIOR CERVICAL PLATE SYSTEM
RELIANCE MEDICAL SYSTEMS, LLC     510(k) NO: K122216(TRADITIONAL)
ATTN: BRET M BERRY                PHONE NO : 801 294 3280   
545 SOUTH 500 WEST SUITE 100      SE DECISION MADE: 05-SEP-12
BOUNTIFUL UT 84010                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTION
I-SENS, INC.                      510(k) NO: K121654(SPECIAL)
ATTN: HYUN  JOON OH               PHONE NO : 822 916619 1
465-6 WOLGYE-DONG, NOWON-GU       SE DECISION MADE: 05-SEP-12
SEOUL    KS 139-845               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TERUMO SURFLASH SAFETY I.V. CATHETER
TERUMO CORPORATION                510(k) NO: K122544(TRADITIONAL)
ATTN: SANDI  HARTKA               PHONE NO : 410 392 7231
1727-1, TSUIJIARAI, SHOWA-CHO NAKASE DECISION MADE: 05-SEP-12
YAMANASHI    JA 409-3853          510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: STRYKER SDC3 HD INFORMATION MANAGEMENT SYSTEM
STRYKER ENDOSCOPY                 510(k) NO: K121893(TRADITIONAL)
ATTN: LIFEI  LIU                  PHONE NO : 408 754 2315   
5900 OPTICAL CT.                  SE DECISION MADE: 05-SEP-12
SAN JOSE CA 95138                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: LOQTEQ LARGE FRAGMENT SET LOQTEQ CORTICAL SCREW 4.5, SMALL HEAD, T25, SELF TAPPING LOQTEQ CORTICAL SCREW 4.5, T25, SELF
AAP IMPLANTATE AG                 510(k) NO: K113648(TRADITIONAL)
ATTN: MARC  SEEGERS               PHONE NO : 493 075 019192
LORENZWEG 5                       SE DECISION MADE: 06-SEP-12
BERLIN    GM 12099                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMPELLA 2.5 PLUS CATHETER
ABIOMED, INC.                     510(k) NO: K112892(SPECIAL)
ATTN: CAROLYN  PEKAR              PHONE NO : 978 646 1639   
22 CHERRY HILL DR.                SE DECISION MADE: 06-SEP-12
DANVERS MA 01923                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FOCUS TOUCH CONCEPTION SYSTEM
INTIMATE BRIDGE 2 CONCEPTION, INC 510(k) NO: K112200(TRADITIONAL)
ATTN: NIKI C SPANIEL              PHONE NO : 724 327 0230   
3919 WILLIAM PENN HIGHWAY SUITE 20SE DECISION MADE: 06-SEP-12
MURRYSVILLE PA 15668              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PADLOCK CLIP-12
APONOS MEDICAL CORP.              510(k) NO: K120814(TRADITIONAL)
ATTN: JOHN  FEE                   PHONE NO : 603 702 0066   
16 HILLSIDE RD.                   SE DECISION MADE: 06-SEP-12
KINGSTON NH 03848                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM
CONFORMIS, INC.                   510(k) NO: K121974(TRADITIONAL)
ATTN: AMITA S SHAH                PHONE NO : 781 345 9164   
11 NORTH AVENUE                   SE DECISION MADE: 06-SEP-12
BURLINGTON MA 01803               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM
DIASORIN, INC.                    510(k) NO: K122397(TRADITIONAL)
ATTN: CAROL A DEPOUW              PHONE NO : 651 351 5850   
1951 NORTHWESTERN AVE. P.O. BOX 28SE DECISION MADE: 06-SEP-12
STILLWATER MN 55082 0285          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES
DATASCOPE CORP., CARDIAC ASSIST DI510(k) NO: K122628(SPECIAL)
ATTN: CARLA S CERQUEIRA           PHONE NO : 973 709 7340   
15 LAW DR.                        SE DECISION MADE: 06-SEP-12
FAIRFIELD NJ 07004 0011           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE
ADVANCED SURGICAL CONCEPTS        510(k) NO: K121309(SPECIAL)
ATTN: JONATHAN  KAHAN             PHONE NO : 202 637 5794   
355 THIRTEENTH STREET, NW COLUMBIASE DECISION MADE: 06-SEP-12
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LOUTREX TOPICAL CREAM
ACELLA PHARMACEUTICALS, LLC       510(k) NO: K120730(TRADITIONAL)
ATTN: LARA  NOAH                  PHONE NO : 803 831 7657   
248 LATITUDE LANE SUITE 104       SE DECISION MADE: 06-SEP-12
LAKE WYLIE SC 29710               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LENSSX LASER SYSTEM
ALCON LENSX, INC.                 510(k) NO: K120732(TRADITIONAL)
ATTN: JUDY  GORDON                PHONE NO : 949 715 0609   
733 BOLSANA DRIVE                 SE DECISION MADE: 06-SEP-12
LAGUNA BEACH CA 92651             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DEPUY CTA REVERSE SHOULDER SYSTEM
DEPUY FRANCE                      510(k) NO: K122442(SPECIAL)
ATTN: MEGAN  BURNS                PHONE NO : 574 372 7745   
700 ORTHOPAEDIC DRIVE             SE DECISION MADE: 06-SEP-12
WARSAW IN 46580                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAXLOCK EXTREME SYSTEM
ORTHOHELIX SURGICAL DESIGNS, INC. 510(k) NO: K122005(SPECIAL)
ATTN: DEREK  LEWIS                PHONE NO : 330 969 9562   
1065 Medina Rd. SUITE 500         SE DECISION MADE: 06-SEP-12
Medina OH 44256                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SNOWDEN PENCER LAPAROSCOPIC ERGONOMIC REPOSABLE SCISSORS
CAREFUSION 2200, INC.             510(k) NO: K113407(TRADITIONAL)
ATTN: KATE  FULLER                PHONE NO : 847 473 7334   
1500 WAUKEGAN ROAD                SE DECISION MADE: 07-SEP-12
MCGAW PARK IL 60085               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM
TRANSONIC SYSTEMS, INC.           510(k) NO: K113821(TRADITIONAL)
ATTN: NAVEEN  THURAMALLA          PHONE NO : 607 257 5300   
34 Dutch Mill Rd                  SE DECISION MADE: 07-SEP-12
ITHACA NY 14850                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INFRARED THERMOMETER
FAMIDOC TECHNOLOGY CO., LTD       510(k) NO: K113761(TRADITIONAL)
ATTN: LEON  CAO                   PHONE NO : 867 552 7864342
East 2/F,Zhixiang Building,71 BLOCSE DECISION MADE: 07-SEP-12
SHENZHEN    CH 518101             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PONTO BONE ANCHORED HEARING SYSTEM
OTICON MEDICAL AB                 510(k) NO: K121228(TRADITIONAL)
ATTN: KAROLIN ISBERG  JERNBY      PHONE NO : 463 174 86153
EKONOMIVAGEN 2                    SE DECISION MADE: 07-SEP-12
ASKIM    SW SE-436 33             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: B&W DENTAL IMPLANT SYSTEM
B&W SRL                           510(k) NO: K120875(TRADITIONAL)
ATTN: PRIYA  BHUTANI              PHONE NO : 54 11 48637878
CORRIENTES 3859                   SE DECISION MADE: 07-SEP-12
BUENOS AIRES    AR AR             510(k) STATEMENT

DEVICE: MINIARC PRO SINGLE-INCISION SLING SYSTEM
AMERICAN MEDICAL SYSTEMS          510(k) NO: K121641(TRADITIONAL)
ATTN: RENEE  MELLUM               PHONE NO : 952 930 6458   
10700 BREN ROAD WEST              SE DECISION MADE: 07-SEP-12
MINNETONKA MN 55343               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITROS CHEMISTRY PRODUCTS DHDL SLIDES
ORTHO-CLINICAL DIAGNOSTICS, INC.  510(k) NO: K120609(SPECIAL)
ATTN: MARLENE A HANNA             PHONE NO : 585 453 4041   
100 INDIGO CREEK DR.              SE DECISION MADE: 07-SEP-12
ROCHESTER NY 14646 5101           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERACIA
SHOFU DENTAL CORPORATION          510(k) NO: K121749(TRADITIONAL)
ATTN: DAVID P MORAIS              PHONE NO : 760 736 3277   
1225 STONE DRIVE                  SE DECISION MADE: 07-SEP-12
SAN MARCOS CA 92078               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEMOCUE HBA1C 501
INFOPIA CO., LTD                  510(k) NO: K121366(SPECIAL)
ATTN: MARIA F GRIFFIN             PHONE NO : 704 843 1675   
55 NORTHERN BLVD. SUITE 200       SE DECISION MADE: 07-SEP-12
GREAT NECK NY 11021               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITREAVIEW
VITAL IMAGES, INC.                510(k) NO: K122136(TRADITIONAL)
ATTN: IAN  NEMEROV                PHONE NO : 952 487 9622   
5850 Opus Pkwy Ste 300            SE DECISION MADE: 07-SEP-12
MINNETONKA MN 55343               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MASIMO SET USPO2 PULSE OXIMETRY CABLE
MASIMO CORPORATION                510(k) NO: K121914(SPECIAL)
ATTN: DAVID  COLLETTE             PHONE NO : 949 297 7000   
40 PARKER                         SE DECISION MADE: 07-SEP-12
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS
SMITH & NEPHEW, INC.              510(k) NO: K121714(TRADITIONAL)
ATTN: BRADLEY  HEIL               PHONE NO : 901 399 6339   
1450 BROOKS RD.                   SE DECISION MADE: 07-SEP-12
MEMPHIS TN 38116                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARROW PICC POWERED BY ARROW VPS STYLET
ARROW INTERNATIONAL(SUBSIDIARY OF 510(k) NO: K121941(SPECIAL)
ATTN: ELIZABETH  DUNCAN           PHONE NO : 610 378 0131   
2400 BERNVILLE RD.                SE DECISION MADE: 07-SEP-12
READING PA 19605                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZYNO MEDICAL ADMINISTRATION SET
ZYNO MEDICAL LLC                  510(k) NO: K120685(ABBREVIATED)
ATTN: CHAOYOUNG  LEE              PHONE NO : 508 650 2008   
10 TECH CIRCLE                    SE DECISION MADE: 07-SEP-12
NATICK MA 01760                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MINI PATCH
WELL-LIFE HEALTHCARE LIMITED      510(k) NO: K121353(ABBREVIATED)
ATTN: CHIN-CHIN  HSIEH            PHONE NO : 886 229 282112
1FL, NO.16, LANE 454 JUNGJENG RD. SE DECISION MADE: 07-SEP-12
YUNGHE CITY, TAIPEI COUNTY    TW C510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE
VASCULAR SOLUTIONS ZERUSA LTD.    510(k) NO: K122301(TRADITIONAL)
ATTN: JENNIFER  RUETHER           PHONE NO : 763 656 4370   
6464 SYCAMORE COURT               SE DECISION MADE: 07-SEP-12
MINNEAPOLIS MN 55369              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MR VESSELLQ XPRESS
GE MEDICAL SYSTEMS SCS            510(k) NO: K122164(TRADITIONAL)
ATTN: HELEN  PENG                 PHONE NO : 262 548 5091   
3000 NORTH GRANDVIEW W1140        SE DECISION MADE: 07-SEP-12
WAUKESHA WI 53188                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM CURVED LINEAR ARRAY 2-5 MHZ TRANSDUCER LINEAR ARRAY 5-11 MHZ TRANSDUCER PHASE ARRA
BENQ MEDICAL TECHNOLOGY CORPATION 510(k) NO: K121983(TRADITIONAL)
ATTN: BOB  LEIKER                 PHONE NO : 925 556 1302   
7263 CRONIN CIRCLE                SE DECISION MADE: 07-SEP-12
DUBLIN CA 94568                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B
BECTON, DICKINSON AND COMPANY     510(k) NO: K121797(TRADITIONAL)
ATTN: GREGORY P PAYNE, RAC        PHONE NO : 858 795 7890   
10865 ROAD TO THE CURE, SUITE 200 SE DECISION MADE: 07-SEP-12
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BENCOX MIRABO CUP BENCOX MIRABO INSERT (STANDARD& ELEVATED TYES) BENCOX MIRABO CUP SCREW HOLE PLUG
CORENTEC CO., LTD                 510(k) NO: K120924(SPECIAL)
ATTN: J.S.  DANIEL                PHONE NO : 820 743 933819
11TH CHUNGHO TOWER 748-1 BANPO 1 DSE DECISION MADE: 10-SEP-12
SEOCHO GU, SEOUL    KS 137-040    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE
BAROSENSE, INC                    510(k) NO: K120126(SPECIAL)
ATTN: SHELIA  STEVENS, PHD        PHONE NO : 650 362 6000   
250 CHESAPEAKE DRIVE              SE DECISION MADE: 10-SEP-12
REDWOOD CITY CA 94063             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UNITY TOATAL KNEE SYSTEM
CORIN U.S.A.                      510(k) NO: K113060(TRADITIONAL)
ATTN: LUCINDA  GERBER             PHONE NO : 813 977 4469   
10500 UNIVERSITY CENTER DR., SUITESE DECISION MADE: 10-SEP-12
TAMPA FL 33612                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ESENSOR RESPIRATORY VIRAL PANEL
CLINICAL MICRO SENSORS, INC.      510(k) NO: K113731(TRADITIONAL)
ATTN: JOEL  CENTENO               PHONE NO : 760 448 4304   
5964 LA PLACE COURT               SE DECISION MADE: 10-SEP-12
CARLSBAD CA 92008                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
SIAM SEMPERMED CORP. LTD.         510(k) NO: K122363(ABBREVIATED)
ATTN: WILLIAM E HARRIS            PHONE NO : 727 787 7250   
13900 49TH STREET NORTH           SE DECISION MADE: 10-SEP-12
CLEARWATER FL 33762               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX
MAQUET CARDIOVASCULAR, LLC        510(k) NO: K122612(TRADITIONAL)
ATTN: MARYLOU  INSINGA            PHONE NO : 973 709 7442   
45 BARBOUR POND DRIVE             SE DECISION MADE: 10-SEP-12
WAYNE NJ 07470                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KDL DISPOSABLE INFUSION SET
SHANGHAI KINDLY ENT. DEVELOPMENT G510(k) NO: K112204(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 86 216 4264467
P.O. BOX 237-023                  SE DECISION MADE: 10-SEP-12
SHANGHAI    CH 200237             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ETS BLUE POWDER-FREE PATIENT NITRILE EXAMINATION GLOVES
NORTHSTAR HEALTHCARE HOLDINGS     510(k) NO: K121947(TRADITIONAL)
ATTN: WESLEY  TOAVS               PHONE NO : 441 278 3827
HAMILTON HOUSE, 10 QUEEN ST       SE DECISION MADE: 10-SEP-12
HAMILTON, BERMUDA    EI HM11      510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: TAPERSET HIP SMALL STEMS
CONSENSUS ORTHOPEDICS, INC.       510(k) NO: K121935(SPECIAL)
ATTN: MATTHEW M HULL              PHONE NO : 916 355 7156   
1115 WINDFIELD WAY, SUITE 100     SE DECISION MADE: 10-SEP-12
EL DORADO HILLS CA 95762          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VISIONS PV .035 DITITAL IVUS CATHETER
VOLCANO CORPORATION               510(k) NO: K121273(ABBREVIATED)
ATTN: MARILYN  POURAZAR           PHONE NO : 858 720 4116   
3661 Valley Centre Drive Suite 200SE DECISION MADE: 10-SEP-12
San Diego CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LANX SPINAL FIZATION SYSTEM
LANX, INC.                        510(k) NO: K121316(TRADITIONAL)
ATTN: WILLIAM  SANDUL             PHONE NO : 303 443 7500   
310 INTERLOCKEN PARKWAY SUITE 120 SE DECISION MADE: 10-SEP-12
BROOMFIELD CO 80021               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
ANDON HEALTH CO., LTD             510(k) NO: K121372(SPECIAL)
ATTN: LIU  YI                     PHONE NO : 862 260 526161
No. 3 Jin Ping Street,Ya An Road, SE DECISION MADE: 10-SEP-12
TIANJIN    CN 300190              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EARLYSENSE CENTRAL DISPLAY SYSTEM
EARLYSENSE LTD.                   510(k) NO: K121885(SPECIAL)
ATTN: DALIA  ARGAMAN              PHONE NO : 972 375 22330X160
12 TZVI ST                        SE DECISION MADE: 10-SEP-12
RAMAT-GAN    IS 52504             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DELICOT
AMERICAN SURGICAL COMPANY, LLC    510(k) NO: K121822(SPECIAL)
ATTN: ERIK  PIASIO                PHONE NO : 781 592 7200   
82 SANDERSON AVENUE               SE DECISION MADE: 10-SEP-12
Lynn MA 01902                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTEGRA CAMINO ICP MONITOR
INTRGRA LIFESCIENCES CORPORATION  510(k) NO: K121573(TRADITIONAL)
ATTN: ERIN  DOYLE                 PHONE NO : 609 936 3634   
311 ENTERPRISE DRIVE              SE DECISION MADE: 10-SEP-12
PLAINSBORO NJ 08536               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MYOSURE XL TISSUE REMOVAL DEVICE (1 PACK) MYOSURE XL TISSUE REMOVAL DEVICE (3 PACK)
HOLOGIC, INC.                     510(k) NO: K122498(SPECIAL)
ATTN: SARAH  FAIRFIELD            PHONE NO : 508 263 8857   
250 CAMPUS DRIVE                  SE DECISION MADE: 10-SEP-12
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED)
ABBOTT LABORATORIES               510(k) NO: K120009(TRADITIONAL)
ATTN: JOHN  RIZOS                 PHONE NO : 847 935 1813   
100 ABBOTT PARK ROAD DEPT 9V6, AP5SE DECISION MADE: 11-SEP-12
ABBOTT PARK IL 60064              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EUROIMMUN ANTI-LKM-1 ELISA(LGG)
EUROIMMUN US                      510(k) NO: K112223(TRADITIONAL)
ATTN: KATHRYN  KOHL               PHONE NO : 973 656 1000   
1100 THE AMERICAN ROAD            SE DECISION MADE: 11-SEP-12
MORRIS PLAINS NJ 07950            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EUROIMMUN ANTI-SLA/LP ELISA(LGG)
EUROIMMUN US                      510(k) NO: K112221(TRADITIONAL)
ATTN: KATHRYN  KOHL               PHONE NO : 973 656 1000   
1100 THE AMERICAN ROAD            SE DECISION MADE: 11-SEP-12
MORRIS PLAINS NJ 07950            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE BLACK NITRILE EXAMINATION GLOVES
TG MEDICAL SDN BHD                510(k) NO: K113393(TRADITIONAL)
ATTN: NOOR A SAIDIN               PHONE NO : 033 392 7880
LOT 5091, JALAN TERATAI, BT 5, OFFSE DECISION MADE: 11-SEP-12
KLANG, SELANGOR    MY 41050       510(k) STATEMENT

DEVICE: ABUTMENT FOR COMPETITIVE IMPLANT NOBEL ACTIVE CONNECTION
BIOMET 3I                         510(k) NO: K120776(SPECIAL)
ATTN: TAMARA  WEST                PHONE NO : 561 776 6831   
4555 RIVERSIDE DR.                SE DECISION MADE: 11-SEP-12
Palm Bch Gdns FL 33410            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWER-FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR
SHEN WEI (USA), INC.              510(k) NO: K121528(TRADITIONAL)
ATTN: ALBERT  LI                  PHONE NO : 540 429 8692   
33278 CENTRAL AVE., SUITE 102     SE DECISION MADE: 11-SEP-12
UNION CITY CA 94587               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT
BECKMAN COULTER, INC.             510(k) NO: K121492(SPECIAL)
ATTN: ANNETTE  HELLIE             PHONE NO : 714 961 4517   
250 SOUTH KRAEMER BLVD A2.SW.09   SE DECISION MADE: 11-SEP-12
BREA CA 92822                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROTH NET RETRIEVER
UNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K122462(SPECIAL)
ATTN: CARROLL  MARTIN             PHONE NO : 440 639 4494   
5976 HEISELY RD.                  SE DECISION MADE: 11-SEP-12
MENTOR OH 44060                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOMATOM DEFINITION
SIEMENS MEDICAL SYSTEMS, INC.     510(k) NO: K122471(SPECIAL)
ATTN: KIMBERLY  MANGUN            PHONE NO : 610 448 4912   
51 VALLEY STREAM PARKWAY          SE DECISION MADE: 11-SEP-12
MALVERN PA 19355 1406             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION)
PROSURG, INC.                     510(k) NO: K120766(TRADITIONAL)
ATTN: A.  DESAI                   PHONE NO : 408 945 4044   
2195 TRADE ZONE BLVD.             SE DECISION MADE: 11-SEP-12
SAN JOSE CA 95131                 510(k) STATEMENT

DEVICE: C2-9-D ULTRASOUND TRANSDUCER
GE HEALTHCARE                     510(k) NO: K122515(SPECIAL)
ATTN: BRYAN  BEHN                 PHONE NO : 414 721 4214   
9900 INNOVATION DRIVE             SE DECISION MADE: 11-SEP-12
WAUWATOSA WI 53226                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RANGE SPINAL SYSTEM
K2M, INC.                         510(k) NO: K121630(TRADITIONAL)
ATTN: NANCY  GIEZEN               PHONE NO : 703 777 3155   
751 MILLER DR., S.E., SUITE F1    SE DECISION MADE: 11-SEP-12
Leesburg VA 20175                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUINTEX CERVICAL PLATING SYSTEM
AESCULAP IMPLANT SYSTEMS, LLC     510(k) NO: K121801(TRADITIONAL)
ATTN: LISA  BOYLE                 PHONE NO : 610 797 9300   
3773 CORPORATE PARKWAY            SE DECISION MADE: 11-SEP-12
CENTER VALLEY PA 18034            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTEGRA JARIT VIDEO ASSISTED THORACIC SURGERY INSTRUMENTS
INTEGRA LIFESCIENCES CORPORATION  510(k) NO: K120012(TRADITIONAL)
ATTN: STEPHANIE  SHEESLEY         PHONE NO : 717 840 2774   
589 DAVIES DRIVE                  SE DECISION MADE: 11-SEP-12
YORK PA 17402                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NUVASIVE PRECEPT SPINAL SYSTEM
NUVASIVE, INC.                    510(k) NO: K122352(TRADITIONAL)
ATTN: ELIAS  KETCHUM              PHONE NO : 858 320 4588   
7475 LUSK BLVD                    SE DECISION MADE: 11-SEP-12
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VOLUSON P6, VOLUSON P8
GE HEALTHCARE                     510(k) NO: K122387(TRADITIONAL)
ATTN: BRYAN  BEHN                 PHONE NO : 414 721 4214   
9900 INNOVATION DRIVE             SE DECISION MADE: 11-SEP-12
WAUWATOSA WI 53226                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROTECTOR, INJECTOR, CONNECTOR
BD MEDICAL-MEDICAL SURGICAL SYSTEM510(k) NO: K120384(TRADITIONAL)
ATTN: JOHN  ROBERTS               PHONE NO : 201 847 5473   
1 BECTON DRIVE                    SE DECISION MADE: 12-SEP-12
FRANKLIN LAKES NJ 07417           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVES
SGMP CO., LTD.                    510(k) NO: K112693(TRADITIONAL)
ATTN: JANNA P TUCKER              PHONE NO : 775 342 2612   
198 AVENUE DE LA D'EMERALD        SE DECISION MADE: 12-SEP-12
SPARKS NV 89434                   510(k) STATEMENT

DEVICE: LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D LAVA ULTIMATE IMPLANT CROWN RESTOR
3M COMPANY                        510(k) NO: K122569(TRADITIONAL)
ATTN: GINGER  CANTOR              PHONE NO : 651 733 1317   
2510 CONWAY AVENUE                SE DECISION MADE: 12-SEP-12
ST. PAUL MN 55144                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE
CARESTREAM DENTAL LLC             510(k) NO: K122427(SPECIAL)
ATTN: DANIEL  HOEFER              PHONE NO : 770 226 3287   
1765 THE EXCHANGE                 SE DECISION MADE: 12-SEP-12
ATLANTA GA 30339                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STRYKER VIDEO URETEROSCOPE
STRYKER ENDOSCOPY                 510(k) NO: K121112(TRADITIONAL)
ATTN: KEVIN  POTGIETER, RAC       PHONE NO : 408 754 2000   
5900 OPTICAL CT.                  SE DECISION MADE: 12-SEP-12
SAN JOSE CA 95138                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALCO-SCREEN 02
CHEMATICS, INC.                   510(k) NO: K121256(TRADITIONAL)
ATTN: CARL  REYNOLDS              PHONE NO : 513 265 6257   
P.O. BOX 293 HIGHWAY 13 SOUTH     SE DECISION MADE: 12-SEP-12
NORTH WEBSTER IN 46555            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AYCAN MOBILE
AYCAN DIGITALSYSTEME GMBH         510(k) NO: K122260(TRADITIONAL)
ATTN: MATTHIAS  BROENNER          PHONE NO : 49 931 2704090
INNERE AUMUEHL STRASSE 5          SE DECISION MADE: 12-SEP-12
WUERZBURG    GM 97076             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITAL COUGH
LUNG ASSIST, INC.                 510(k) NO: K120277(TRADITIONAL)
ATTN: LEWIS  WARD                 PHONE NO : 303 516 1024   
4655 KIRKWOOD COURT               SE DECISION MADE: 12-SEP-12
BOULDER CO 80301                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LABONACHECK ALC
CERAGEM INTERNATIONAL, INC.       510(k) NO: K111128(TRADITIONAL)
ATTN: RAYMOND  CHUNG              PHONE NO : 213 480 7168   
3699 WILSHIRE BLVD.,SUITE 930     SE DECISION MADE: 13-SEP-12
LOS ANGELES CA 90010              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMMUNOCAP ALLERGEN COMPONENTS BUNDLE
PHADIA US INC.                    510(k) NO: K113841(TRADITIONAL)
ATTN: MARTIN  MANN                PHONE NO : 269 492 1957   
4169 COMMERCIAL AVE.              SE DECISION MADE: 13-SEP-12
PORTAGE MI 49002                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERRAD(R) 100NX STERILIZER DUO CYCLE
ADVANCED STERILIZATION PRODUCTS   510(k) NO: K111377(TRADITIONAL)
ATTN: NANCY  CHU                  PHONE NO : 949 453 6435   
33 TECHNOLOGY DR.                 SE DECISION MADE: 13-SEP-12
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVE
LIFESTYLE SAFTY PRODUCTS (HUI ZHOU510(k) NO: K112741(ABBREVIATED)
ATTN: RHONDA T ALEXANDER          PHONE NO : 757 224 0177   
MEDICAL DEVICE & DRUG DEVISION 144SE DECISION MADE: 13-SEP-12
HAMPTON VA 23666                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIAMO SSA-640A V4.0
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K122491(TRADITIONAL)
ATTN: CHARLEMAGNE  CHUA           PHONE NO : 714 730 5000   
2441 MICHELLE DRIVE               SE DECISION MADE: 13-SEP-12
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: TRIA LASER HAIR REMOVAL SYSTEM
TRIA BEAUTY, INC.                 510(k) NO: K120737(TRADITIONAL)
ATTN: JONATHAN  KAHAN             PHONE NO : 202 638 5794   
555 13TH STREET, NW COLUMBIA SQUARSE DECISION MADE: 13-SEP-12
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VAN GOGH ANTERIOR CERVICAL PLATE SYSTEM
ACCEL SPINE                       510(k) NO: K121078(TRADITIONAL)
ATTN: DANIEL  CHON                PHONE NO : 800 713 9489   
14850 Quorum Dr Ste 220           SE DECISION MADE: 13-SEP-12
Dallas TX 75254                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JAZZ SYSTEM
IMPLANET S.A.                     510(k) NO: K121541(TRADITIONAL)
ATTN: JANICE M HOGAN              PHONE NO : 267 675 4611   
1835 MARKET ST. 29TH FLOOR        SE DECISION MADE: 13-SEP-12
PHILADELPHIA PA 19103             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUS
BOSTON SCIENTIFIC CORP.           510(k) NO: K121774(TRADITIONAL)
ATTN: BETH  TOROK                 PHONE NO : 763 494 1273   
ONE SCIMED PLACE                  SE DECISION MADE: 13-SEP-12
MAPLE GROVE MN 55311              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STREPTOCOCCUS APP. SEROLOGICAL REAGENTS
MERIDIAN BIOSCIENCE, INC.         510(k) NO: K122019(TRADITIONAL)
ATTN: MICHELLE L SMITH            PHONE NO : 513 271 3700   
3471 RIVER HILLS DR.              SE DECISION MADE: 13-SEP-12
CINCINNATI OH 45244               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PATIENT POSITIONING SYSTEM
FORTE AUTOMATION SYSTEMS, INC.    510(k) NO: K122413(TRADITIONAL)
ATTN: PHIL  REECE                 PHONE NO : 815 633 2300   
8155 Burden Rd                    SE DECISION MADE: 13-SEP-12
Machesney Park IL 61115           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2
OPTIM LLC                         510(k) NO: K122593(SPECIAL)
ATTN: JEFF  BARRETT               PHONE NO : 508 347 5100   
64 TECHNOLOGY PARK RD             SE DECISION MADE: 13-SEP-12
STURBRIDGE MA 01566               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: G-DERM POWDER-FREE SYNTHETIC SURGICAL GLOVE
HUTCHINSON SANTE S.N.C.           510(k) NO: K121335(TRADITIONAL)
ATTN: RAFFI  KRIKORIAN            PHONE NO : 330 344 738700
RUE MARRET PATUREL                SE DECISION MADE: 13-SEP-12
LIANCOURT    FR F-60140           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GSI VIEWER WITH VUE OPTION
GE MEDICAL SYSTEMS SCS            510(k) NO: K121827(TRADITIONAL)
ATTN: HELEN  PENG                 PHONE NO : 262 548 5091   
3000 NORTH GRANDVIEW W1140        SE DECISION MADE: 13-SEP-12
WAUKESHA WI 53188                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VELASHAPE
SYNERON MEDICAL LTD.              510(k) NO: K122579(SPECIAL)
ATTN: SAM  WADE                   PHONE NO : 972 54 3303402
INDUSTRIAL ZONE TAVOR BLDG P.O.B 5SE DECISION MADE: 13-SEP-12
YOKNEAM, ILLIT    IS 20692        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIM
INNEROPTIC TECHNOLOGY, INC        510(k) NO: K121479(TRADITIONAL)
ATTN: CAROLINE  GREEN             PHONE NO : 919 732 2090   
106-A N CHURTON ST                SE DECISION MADE: 13-SEP-12
HILLSBOROUGH NC 27278             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DX-D FULL LEG FULL SPINE
AFGA HEALTHCARE N.V.              510(k) NO: K122119(TRADITIONAL)
ATTN: DAVID  LEDWIG               PHONE NO : 828 862 8555   
PO BOX 1927                       SE DECISION MADE: 13-SEP-12
BREVARD NC 28712                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIRTUOST
O.N. DIAGNOSTICS                  510(k) NO: K113725(TRADITIONAL)
ATTN: DAVID  KOPPERDAHL           PHONE NO : 510 204 0688   
2150 SHATTUCK AVE. SUITE 610      SE DECISION MADE: 13-SEP-12
BERKELEY CA 94704                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AFFINITY PIXIE OXYGENATION SYSTEM WITH CARMEDA BIOACTIVE SURFACE OR BALANCE BIOSURFACE
MEDTRONIC INC.                    510(k) NO: K100645(TRADITIONAL)
ATTN: JESSICA  SIXBERRY           PHONE NO : 763 514 9849   
7611 NORTHLAND DRIVE              SE DECISION MADE: 14-SEP-12
BROOKLYN PARK MN 55428            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SYRINGE KIT
SMITHS MEDICAL ASD, INC.          510(k) NO: K110053(TRADITIONAL)
ATTN: CINDY  ENGELHARDT           PHONE NO : 603 352 3812   
10 BOWMAN DR.                     SE DECISION MADE: 14-SEP-12
KEENE NH 03431                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CORIN METAFIX HIP STEM
CORIN U.S.A.                      510(k) NO: K121439(TRADITIONAL)
ATTN: LUCINDA  GERBER             PHONE NO : 813 977 4469   
10500 UNIVERSITY CENTER DR., SUITESE DECISION MADE: 14-SEP-12
TAMPA FL 33612                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMAGER II ANGIOGRAPHIC CATHETER
BOSTON SCIENTIFIC CORP.           510(k) NO: K121694(TRADITIONAL)
ATTN: HOLLY  RAMIREZ              PHONE NO : 763 484 2113   
ONE SCIMED PLACE                  SE DECISION MADE: 14-SEP-12
MAPLE GROVE MN 55311              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OXFORD ANKLE FUSION NAIL(AFN) SYSTEM
ORTHO SOLUTIONS LIMITED           510(k) NO: K121575(TRADITIONAL)
ATTN: AL  LIPPINCOTT              PHONE NO : 952 492 5858   
3150 EAST 200TH STREET            SE DECISION MADE: 14-SEP-12
PRIOR LAKE MN 55372               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LULLABY TM WARMER
WIPRO GE HEALTHCARE PRIVATE, LTD. 510(k) NO: K121625(TRADITIONAL)
ATTN: AGATA  ANTHONY              PHONE NO : 410 456 0329   
8880 GOMAN ROAD                   SE DECISION MADE: 14-SEP-12
LAUREL MD 20723 5800              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERRAD (R) CYCLESURE (R) 24 BIOLOGICAL INDICATOR
ADVANCED STERILIZATION PRODUCTS   510(k) NO: K111375(TRADITIONAL)
ATTN: NANCY  CHU                  PHONE NO : 949 453 6435   
33 TECHNOLOGY DR.                 SE DECISION MADE: 14-SEP-12
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUPRA SCAN DELIVERY SYSTEM
QUANTEL MEDICAL                   510(k) NO: K120825(TRADITIONAL)
ATTN: MAUREEN  O'CONNELL          PHONE NO : 978 207 1245   
5 TIMBER LANE                     SE DECISION MADE: 14-SEP-12
NORTH READING MA 01864            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PEEK CUSTOMIZED CRAIAL IMPLANT KIT
STRYKER                           510(k) NO: K121153(TRADITIONAL)
ATTN: MANISH  PATEL               PHONE NO : 269 389 4271   
750 TRADE CENTER WAY STE 200      SE DECISION MADE: 14-SEP-12
PORTAGE MI 49002                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZMR HIP SYSTEM  KWZ-PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
ZIMMER, INC.                      510(k) NO: K113296(TRADITIONAL)
ATTN: DANIEL J WILLIMAN           PHONE NO : 574 371 8065   
P.O. BOX 708                      SE DECISION MADE: 14-SEP-12
WARSAW IN 46581 0708              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGNITY POWER INJECTABLE TITANIUM PORT
MEDICAL COMPONENTS INC            510(k) NO: K120281(TRADITIONAL)
ATTN: ROSANNA  SEVERINI           PHONE NO : 215 256 4201   
1499 DELP DRIVE                   SE DECISION MADE: 17-SEP-12
HARLEYSVILLE PA 19438             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODEL FAMILY OF AEROLASE ND:YAG LASERS: FRIENDLYLIGHT ND: YAG LASERS, FRIENDLYLIGHT NEO, LIGHTPOD ND: YAG LASERS, LIGHTP
AEROLASE MEDICAL LASERS LLC       510(k) NO: K120235(TRADITIONAL)
ATTN: JENNIFER A HENDERSON        PHONE NO : 202 637 5783   
555 THIRTEENTH STREET             SE DECISION MADE: 17-SEP-12
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORIGINS LIPOHARVESTING SYSTEM
SOUND SURGICAL TECHNOLOGIES LLC.  510(k) NO: K120328(TRADITIONAL)
ATTN: STEPHEN C  SMITH            PHONE NO : 720 240 2970   
357 McCaslin Blvd Ste 100         SE DECISION MADE: 17-SEP-12
LOUISVILLE CO 80027               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KMC KYPHOPLASTY SYSTEM
SHANGHAI KINETIC MEDICAL CO., LTD 510(k) NO: K113742(TRADITIONAL)
ATTN: GREGORY  MATHISON           PHONE NO : 218 387 1559   
3924CASCADE BEACH ROAD            SE DECISION MADE: 17-SEP-12
LUTSEN MN 55612                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOFIBER SYTURE
TORNIER, INC.                     510(k) NO: K122487(TRADITIONAL)
ATTN: LAEL J PICKETT              PHONE NO : 612 219 7350   
10801 NESBITT AVENUE              SE DECISION MADE: 17-SEP-12
BLOOMINGTON MN 55437              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIV
AMERIWATER                        510(k) NO: K121022(TRADITIONAL)
ATTN: BRIAN  BOWMAN               PHONE NO : 937 461 8833   
1303 STANLEY AVE.                 SE DECISION MADE: 17-SEP-12
DAYTON OH 45404                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TIGRAN PERIBRUSH
TIGRAN TECHNOLOGIES AB            510(k) NO: K121114(TRADITIONAL)
ATTN: ULF  LUNDGREN               PHONE NO : 464 065 01666
Medeon Science Park               SE DECISION MADE: 17-SEP-12
Malmo    SE 205 12                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER, ACCESS
SUREFIRE MEDICAL, INC             510(k) NO: K122506(TRADITIONAL)
ATTN: MARIO  ARBESU               PHONE NO : 305 378 2651   
12415 SW 136 AVENUE UNIT 3        SE DECISION MADE: 17-SEP-12
MIAMI FL 33186                    510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES
KATALYST SURGICAL, LLC            510(k) NO: K121187(TRADITIONAL)
ATTN: MICHELLE  MCDONOUGH         PHONE NO : 202 552 5800   
1331 H ST NW, 12TH FL             SE DECISION MADE: 17-SEP-12
WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BICERA (TM) RESORBABLE BONE SUBSTITUTE
WILTROM CORPORATION LIMITED       510(k) NO: K110949(TRADITIONAL)
ATTN: YUNG-CHIH  WU               PHONE NO : 886 358 28999
NO. 221, SEC 1, CHUNG HSING RD    SE DECISION MADE: 18-SEP-12
CHUTUNG TOWNSHIP, HSINCHU    TW 31510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SCKOONCUP
SCKOON INC.                       510(k) NO: K120107(TRADITIONAL)
ATTN: MOHAMED  ELGAYAR            PHONE NO : 212 228 6903   
2301 COLLINS AVE #310             SE DECISION MADE: 18-SEP-12
MIAMI BEACH FL 33139              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ISIGHT
C & E GP SPECIALISTS, INC.        510(k) NO: K121519(TRADITIONAL)
ATTN: MARTIN  DALSING             PHONE NO : 970 243 5490   
2214 SANFORD DR                   SE DECISION MADE: 18-SEP-12
GRAND JUNCTION CO 81505           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV
BECTON, DICKINSON AND COMPANY     510(k) NO: K121633(TRADITIONAL)
ATTN: GREGORY P PAYNE             PHONE NO : 858 795 7890   
10865 ROAD TO THE CURE, SUITE 200 SE DECISION MADE: 18-SEP-12
SAN DIEGO CA 92064                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLYDESDALE SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC.     510(k) NO: K122591(SPECIAL)
ATTN: BECKY  RONNER               PHONE NO : 800 876 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 18-SEP-12
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER
BOSTON SCIENTIFIC CORP.           510(k) NO: K121614(TRADITIONAL)
ATTN: LAUREN  ANDERSON            PHONE NO : 508 683 4707   
100 BOSTON SCIENTIFIC WAY         SE DECISION MADE: 18-SEP-12
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WALK ON WHEELS HS-3500 ELECTRIC AISLE WHEELCHAIR
WALK ON WHEELS AUSTRALIA PTY LTD  510(k) NO: K120405(TRADITIONAL)
ATTN: SHEILA  RAMERMAN            PHONE NO : 541 683 3017   
927 THRONE DR.                    SE DECISION MADE: 19-SEP-12
EUGENE OR 97402                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM
NIHON KOHDEN CORP.                510(k) NO: K120397(TRADITIONAL)
ATTN: STEVE  GEERDES              PHONE NO : 949 580 1555   
90 ICON STREET                    SE DECISION MADE: 19-SEP-12
FOOTHILL RANCH CA 92610           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SLEEP PROFILER
ADVANCED BRAIN MONITORING, INC.   510(k) NO: K120450(TRADITIONAL)
ATTN: ADRIENNE  LENZ              PHONE NO : 262 290 0023   
W324 S3649 COUNTY RD E            SE DECISION MADE: 19-SEP-12
DOUSMAN WI 53118                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM
BIOMET MICROFIXATION              510(k) NO: K121302(SPECIAL)
ATTN: SHERYL  MALMBERG            PHONE NO : 904 741 9465   
1520 TRADEPORT DR.                SE DECISION MADE: 19-SEP-12
JACKSONVILLE FL 32218             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORTHOCAD SOFTWARE OPTION
ESAOTE, S.P.A.                    510(k) NO: K120288(TRADITIONAL)
ATTN: ALLISON  SCOTT, RAC         PHONE NO : 317 569 9500   
9001 WESLEYAN ROAD SUITE 200      SE DECISION MADE: 19-SEP-12
INDIANAPOLIS IN 46268             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MINDCHILD MERIDIAN FETAL HEART RATE MONITOR
MINDCHILD MEDICAL                 510(k) NO: K120018(TRADITIONAL)
ATTN: LEO  BASTA                  PHONE NO : 617 834 9866   
755 WESTMINSTER STREET UNIT 120   SE DECISION MADE: 19-SEP-12
PROVIDENCE RI 02903               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MERIT HYDROPHILIC GUIDE WIRE
MERIT MEDICAL SYSTEMS, INC.       510(k) NO: K120644(TRADITIONAL)
ATTN: MARK  MULLANEY              PHONE NO : 353 917 03761
PARKMORE BUSINESS PARK WEST       SE DECISION MADE: 19-SEP-12
GALWAY    EI EI                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)
TANGSHAN ZHONGHONG PULIN PLASTIC C510(k) NO: K120968(TRADITIONAL)
ATTN: CHU  XIAOAN                 PHONE NO : 861 082 387441
RM 1606 BLDG 1 JIANXIANG YUAN NO.2SE DECISION MADE: 19-SEP-12
BEIJING    CH CH                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: METS MODULAR DISTAL FEMUR
STANMORE IMPLANTS WORLDWIDE LTD   510(k) NO: K121029(TRADITIONAL)
ATTN: NANCY C MACDONALD           PHONE NO : 781 329 2993   
690 CANTON STREET SUITE 302       SE DECISION MADE: 19-SEP-12
WESTWOOD MA 02090                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: METS MODULAR TOTAL FEMUR
STANMORE IMPLANTS WORLDWIDE LTD.  510(k) NO: K121055(TRADITIONAL)
ATTN: NANCY C MACDONALD           PHONE NO : 781 329 2993   
690 CANTON STREET SUITE 302       SE DECISION MADE: 19-SEP-12
WESTWOOD MA 02090                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MASIMO SET AND MASIMO RAINBOW SET PULSE OXIMETERS AND SENSORS
MASIMO CORPORATION                510(k) NO: K120657(TRADITIONAL)
ATTN: PATRICIA  MILBANK           PHONE NO : 949 297 7000   
40 PARKER                         SE DECISION MADE: 19-SEP-12
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM
PENUMBRA, INC.                    510(k) NO: K121917(TRADITIONAL)
ATTN: MICHAELA  MAHL              PHONE NO : 510 748 3288   
1351 Harbor Bay Parkway           SE DECISION MADE: 19-SEP-12
Alameda CA 94502                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITASCAN LT SCANMASTER
VITACON MEDICAL INC.              510(k) NO: K121689(TRADITIONAL)
ATTN: RON  EVANS                  PHONE NO : 604 291 7747
5355 Parkwood Place               SE DECISION MADE: 19-SEP-12
Richmond    CA V6V 2N1            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDURAMESH
LUCERO MEDICAL, LLC               510(k) NO: K122622(SPECIAL)
ATTN: JENNIFER  PALINCHIK         PHONE NO : 440 933 8850   
33490 PIN OAK PARKWAY             SE DECISION MADE: 19-SEP-12
AVON LAKE OH 44012                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST
NANOSPHERE, INC                   510(k) NO: K122514(TRADITIONAL)
ATTN: MARK  DEL VECCHIO           PHONE NO : 847 400 9000   
4088 COMMERCIAL AVENUE            SE DECISION MADE: 19-SEP-12
NORTHBROOK IL 60062               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL
HOLOGIC, INC.                     510(k) NO: K122563(SPECIAL)
ATTN: SARAH  FAIRFIELD            PHONE NO : 508 263 8857   
250 CAMPUS DRIVE                  SE DECISION MADE: 19-SEP-12
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM
TAIDOC TECHNOLOGY CORPORATION     510(k) NO: K121224(SPECIAL)
ATTN: LINDA  KO                   PHONE NO : 886 266 258188
3F,5F, No.127, Wugong 2nd Rd. WuguSE DECISION MADE: 19-SEP-12
New Taipei City    TW 24888       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIO
RIEMSER ARZEIMITTEL AG            510(k) NO: K113282(SPECIAL)
ATTN: JAMES M CLINTON             PHONE NO : 919 247 0479   
5105 FAIROAKS RD                  SE DECISION MADE: 20-SEP-12
DURHAM NC 27712                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS
INOVA DIAGNOSTICS, INC.           510(k) NO: K113863(TRADITIONAL)
ATTN: GABRIELLA  LAKOS            PHONE NO : 858 586 9900   
9900 OLD GROVE RD.                SE DECISION MADE: 20-SEP-12
SAN DIEGO CA 92131 1638           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION)
INOVISE MEDICAL, INC.             510(k) NO: K120462(TRADITIONAL)
ATTN: EARL  ANDERSON              PHONE NO : 503 431 3800   
8770 SW NIMBUS AVE. SUITE D       SE DECISION MADE: 20-SEP-12
Beaverton OR 97008                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEOMED ORAL/ENTERAL SYRINGE
NEOMED, INC.                      510(k) NO: K122373(SPECIAL)
ATTN: MELINDA  HARRISON           PHONE NO : 770 516 2225   
100 Londonderry Ct Suite 112      SE DECISION MADE: 20-SEP-12
Woodstock GA 30188                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ULTRASAFE PASSIVE NEEDLE GUARD
SAFETY SYRINGES, INC.             510(k) NO: K122558(SPECIAL)
ATTN: SUZANNE  RICHARDSON         PHONE NO : 760 918 9908   
2875 Loker Ave E                  SE DECISION MADE: 20-SEP-12
CARLSBAD CA 92010                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIPER AND EXPEDIUM NAVIGATED INSTRUMENTS
MEDOS INTERNATIONAL SARL          510(k) NO: K120867(TRADITIONAL)
ATTN: LAURA  BLEYENDAAL           PHONE NO : 508 828 3267   
325 PARAMOUNT DRIVE               SE DECISION MADE: 20-SEP-12
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: METS MODULAR PROXIMAL FEMUR
STANMORE IMPLANTS WORLDWIDE LTD.  510(k) NO: K121056(TRADITIONAL)
ATTN: NANCY C MACDONALD           PHONE NO : 781 329 2993   
690 CANTON STREET SUITE 302       SE DECISION MADE: 20-SEP-12
WESTWOOD MA 02090                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERISPINE LC CAGE
SAFE ORTHOPAEDICS                 510(k) NO: K122021(ABBREVIATED)
ATTN: P.  DUMOUCHEL               PHONE NO : 330 134 215000
PARC DES BELLEVUES- ALLEE R LUXEMBSE DECISION MADE: 20-SEP-12
ERAGNY SUR OISE    FR 95610       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2
RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K121724(TRADITIONAL)
ATTN: RON  HASELHORST             PHONE NO : 847 913 1113   
353 CORPORATE WOODS PKWY.         SE DECISION MADE: 20-SEP-12
VERNON HILLS IL 60061             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 1.5T SIGNA HDXT 3.0 SIGNA HDXT SIGNA VIBRABT
GE MEDICAL SYSTEMS, LLC           510(k) NO: K121676(TRADITIONAL)
ATTN: SHASHIDHAR  CS              PHONE NO : 262 521 6848   
3200 N. GRANDVIEW BLVD.           SE DECISION MADE: 20-SEP-12
WAUKESHA WI 53188                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP)
ORTHOFIX SRL                      510(k) NO: K122541(SPECIAL)
ATTN: CANDACE F CEDERMAN          PHONE NO : 503 201 2485   
22423 SKYVIEW DRIVE               SE DECISION MADE: 20-SEP-12
WEST LINN OR 97068                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: E-CUBE 7
ALPINION MEDICAL SYSTEMS CO., LTD 510(k) NO: K121729(TRADITIONAL)
ATTN: YUCHI  CHU                  PHONE NO : 425 949 4907   
SUITE 226, 10604 NE 38TH PLACE    SE DECISION MADE: 20-SEP-12
KIRKLAND WA 98033                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BLUE, LATEX POWDER FREE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH PROTEIN LABLING CLAIM (50UG/DM
NORTHSTAR HEALTHCARE HOLDINGS     510(k) NO: K121926(TRADITIONAL)
ATTN: WESLEY  TOAVS               PHONE NO : 441 278 3827
HAMILTON HOUSE, 10 QUEEN ST       SE DECISION MADE: 20-SEP-12
HAMILTON, BERMUDA    EI HM11      510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: CHAMP CHAMP TRANSIT
CONVAID PRODUCTS, INC.            510(k) NO: K120501(TRADITIONAL)
ATTN: MERVYN  WATKINS             PHONE NO : 310 618 0111   
2830 CALIFORNIA ST.               SE DECISION MADE: 20-SEP-12
TORRANCE CA 90503                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY
MEDEFIL, INC.                     510(k) NO: K121262(SPECIAL)
ATTN: PRADEEP  AGGARWAL           PHONE NO : 630 682 4600   
250 WINDY POINT DR.               SE DECISION MADE: 20-SEP-12
GLENDALE HEIGHTS IL 60139         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CHOICE SPINE FIXATION SYSTEM
CHOICE SPINE, LP                  510(k) NO: K121850(TRADITIONAL)
ATTN: KIM  FINCH                  PHONE NO : 865 246 3969   
400 Erin Dr                       SE DECISION MADE: 20-SEP-12
KNOXVILLE TN 37919                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3
RANDOX LABORATORIES, LTD.         510(k) NO: K113720(TRADITIONAL)
ATTN: PAULINE  ARMSTRONG          PHONE NO : 440 289 4422413
55 DIAMOND RD.                    SE DECISION MADE: 20-SEP-12
CRUMLIN, COUNTY ANTRIM    UK BT29 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VESTIBULAR ANALYSIS APPARATUS
CAPACITY SPORTS, LLC              510(k) NO: K121590(TRADITIONAL)
ATTN: PAMELA M BUCKMAN            PHONE NO : 925 980 7007   
2800 PLEASANT HILL SUITE 175      SE DECISION MADE: 20-SEP-12
PLEASANT HILL CA 94523            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEXTGEN ALTIUS OCT SYSTEM
BIOMET SPINE (AKA EBI, LLC)       510(k) NO: K122378(SPECIAL)
ATTN: VIVIAN  KELLY               PHONE NO : 973 299 9300   
100 INTERPACE PARKWAY             SE DECISION MADE: 20-SEP-12
PARSIPPANY NJ 07054               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CG+ ARROW PICC POWERED BY ARROW VPS STYLET
ARROW INTERNATIONAL(SUBSIDIARY OF 510(k) NO: K122545(SPECIAL)
ATTN: ELIZABETH  DUNCAN           PHONE NO : 610 378 0131   
2400 BERNVILLE RD.                SE DECISION MADE: 20-SEP-12
READING PA 19605                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ECHOSOFT(TM)
ECHOMETRIX LLC                    510(k) NO: K111142(TRADITIONAL)
ATTN: LARRY A KROGER              PHONE NO : 262 549 6646   
2210 WOODHILL WAY                 SE DECISION MADE: 21-SEP-12
WAUKESHA WI 53189                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HUMID-VENT HEPA
TELEFLEX MEDICAL                  510(k) NO: K112958(TRADITIONAL)
ATTN: LIZ  PAUL                   PHONE NO : 919 433 8076   
2917 WECK DR.                     SE DECISION MADE: 21-SEP-12
RESEARCH TRIANGLE PARK NC 27709   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OSTIAL PRO STENT POSITIONING SYSTEM
MERIT MEDICAL SYSTEMS, INC.       510(k) NO: K122089(SPECIAL)
ATTN: DAVID  THOMAS               PHONE NO : 801 316 4956   
1600 WEST MERIT PKWY.             SE DECISION MADE: 21-SEP-12
SOUTH JORDAN UT 84095             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODE
BIOMERICS                         510(k) NO: K121773(TRADITIONAL)
ATTN: EMILY  MADSEN               PHONE NO : 801 355 2705   
2700 S 900 W                      SE DECISION MADE: 21-SEP-12
SALT LAKE CITY UT 84119           510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ADIPREP ADIPOSE TRANSFER SYSTEM
HARVEST TECHNOLOGIES, CORP.       510(k) NO: K121005(TRADITIONAL)
ATTN: GABRIEL J MURACA, JR.       PHONE NO : 508 732 7500   
40 GRISSOM RD, SUITE 100          SE DECISION MADE: 21-SEP-12
PLYMOUTH MA 02360                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT  SPEEDLOCK HIP DRILL SPEEDLOCK HIP GUIDE CROWN TIP SPEEDLOCK HIP PATHFINDER
ARTHROCARE CORPORATION            510(k) NO: K120943(TRADITIONAL)
ATTN: CHERYL  FREDRICK            PHONE NO : 521 358 5751   
7000 WEST WILLIAM CANNON DRIVE BUISE DECISION MADE: 21-SEP-12
AUSTIN TX 78735 0000              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VOLUSON E6/E8/E8EXPERT/E10
GE HEALTHCARE                     510(k) NO: K122327(TRADITIONAL)
ATTN: BRYAN  BEHN                 PHONE NO : 414 721 4214   
9900 W INNOVATION DRIVE           SE DECISION MADE: 21-SEP-12
WAUWATOSA WI 53226                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRISM ACQUIRE PRISM PROCESS PRISM VIEW
PRISM CLINICAL IMAGING, INC.      510(k) NO: K122026(SPECIAL)
ATTN: JAMES L REUSS               PHONE NO : 262 754 3840   
890 Elm Grove Rd., Suite 215      SE DECISION MADE: 21-SEP-12
Elm Grove WI 53122                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALMA LASERS FAMILY OF PIXEL RF TIPS
ALMA LASERS INC.                  510(k) NO: K121150(TRADITIONAL)
ATTN: KATHY  MAYNOR               PHONE NO : 352 586 3113   
485 HALF DAY RD. SUITW NO. 100    SE DECISION MADE: 21-SEP-12
BUFFALO GROVE IL 60089            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ASPIRE HD PLUS, ASPIRE HD-S
FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K121674(TRADITIONAL)
ATTN: PETER  ALTMAN               PHONE NO : 203 602 3576   
419 WEST AVE.                     SE DECISION MADE: 21-SEP-12
STAMFORD CT 06902 6300            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TROOPER OXYGEN CONCENTRATOR
VBOX, INC.                        510(k) NO: K121260(TRADITIONAL)
ATTN: THEODORE  JAGGER            PHONE NO : 651 407 6206   
2342 EAST COUNTY ROAD J           SE DECISION MADE: 21-SEP-12
WHITE BEAR LAKE MN 55110          510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM
MEDICAL COMPONENTS INC            510(k) NO: K121848(SPECIAL)
ATTN: JEAN  CALLOW                PHONE NO : 215 256 4201   
1499 DELP DRIVE                   SE DECISION MADE: 21-SEP-12
HARLEYSVILLE PA 19438             510(k) STATEMENT

DEVICE: BIOMET MICROFIXATION FACIAL PLATING SYSTEM
BIOMET MICROFIXATION              510(k) NO: K121589(SPECIAL)
ATTN: LAUREN  JASPER              PHONE NO : 904 741 9259   
1520 TRADEPORT DR.                SE DECISION MADE: 21-SEP-12
JACKSONVILLE FL 32218             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIAZYME HSCRP POC TEST KIT
DIAZYME LABORATORIES              510(k) NO: K121558(TRADITIONAL)
ATTN: ABHIJIT  DATTA              PHONE NO : 858 455 4762   
12889 GREGG COURT                 SE DECISION MADE: 21-SEP-12
POWAY CA 92064                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DALI SPINAL FIXATION SYSTEM
ACCEL SPINE                       510(k) NO: K121568(TRADITIONAL)
ATTN: DANIEL  CHON                PHONE NO : 800 713 9489   
14850 Quorum Dr Ste 220           SE DECISION MADE: 21-SEP-12
Dallas TX 75254                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AQUILION ONE VISION, V4.90
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K122109(TRADITIONAL)
ATTN: PAUL  BIGGINS               PHONE NO : 714 669 7808   
2441 Michelle Dr                  SE DECISION MADE: 21-SEP-12
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BLOOD PRESSURE MONITOR WITH STETHOSCOPE
HANGZHOU RELI-ON CO., LTD         510(k) NO: K122259(TRADITIONAL)
ATTN: CHARILE  MACK               PHONE NO : 931 625 4938   
77325 JOYCE WAY                   SE DECISION MADE: 24-SEP-12
ECHO OR 97826                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THE PL-1064 LASER SYSTEM
SHEAUMANN LASER, INC              510(k) NO: K120938(TRADITIONAL)
ATTN: TIMOTHY J SHEA              PHONE NO : 407 590 2050   
189 WINDING OAKS LANE             SE DECISION MADE: 24-SEP-12
OVIEDO FL 32765                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INOMAX DS (DELIVERY SYSTEM)
INO THERAPEUTICS                  510(k) NO: K121021(TRADITIONAL)
ATTN: DAVID  TRUEBLOOD            PHONE NO : 608 395 3910   
2902 DAIRY DRIVE                  SE DECISION MADE: 24-SEP-12
MADISON WI 53718                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GEMINI LITHOTRIPTER
DORNIER MEDTECH AMERICA, INC.     510(k) NO: K121656(SPECIAL)
ATTN: JOHN  HOFFER                PHONE NO : 770 514 6163   
1155 ROBERTS BLVD.                SE DECISION MADE: 24-SEP-12
KENNESAW GA 30144                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LEW MDI O-BALL COLLARED IMPLANT,
PARK DENTAL RESEARCH CORP.        510(k) NO: K121707(TRADITIONAL)
ATTN: RONALD  BULARD              PHONE NO : 580 798 4418   
2401 N Commerce St Ste B          SE DECISION MADE: 24-SEP-12
Ardmore OK 73401                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BENEHOLD CHG TRANSPARENT FILM DRESSING (10X12CM) (8.5X12CM) (6.5X7 CM)
AVERY DENNISON BELGIE, BVBA       510(k) NO: K113836(TRADITIONAL)
ATTN: JERZY  WOJCIK               PHONE NO : 312 629 4608   
20N. WACKER DRIVE SUITE 2240      SE DECISION MADE: 24-SEP-12
CHICAGO IL 60606                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST
TIANJIN NEW BAY BIORESEARCH CO., L510(k) NO: K112449(TRADITIONAL)
ATTN: HANN-PING  WANG             PHONE NO : 714 693 0301   
5230 VIA PRIMARIA                 SE DECISION MADE: 24-SEP-12
YORBA LINDA CA 92886              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CHF-Y0005
OLYMPUS MEDICAL SYSTEMS CORP.     510(k) NO: K113120(TRADITIONAL)
ATTN: SHERI  MUSGNUNG             PHONE NO : 484 896 3147   
3500 CORPORATE PARKWAY P.O. BOX 61SE DECISION MADE: 25-SEP-12
CENTER VALLEY PA 18034 0610       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTHREX SUTURE (UHMWPE)
ARTHREX, INC.                     510(k) NO: K122374(SPECIAL)
ATTN: IVETTE  GALMEZ              PHONE NO : 239 643 5553   
1370 CREEKSIDE BLVD.              SE DECISION MADE: 25-SEP-12
NAPLES FL 34108 1945              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURELASE CO2 LASER SYSTEM
CLINICON CORP.                    510(k) NO: K121580(TRADITIONAL)
ATTN: GERALD  PALECKI             PHONE NO : 760 715 5954   
1107 259TH ST NW                  SE DECISION MADE: 25-SEP-12
STANWOOD WA 98292 4834            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZOLL R SERIES
ZOLL MEDICAL CORPORATION, WORLD WI510(k) NO: K120907(TRADITIONAL)
ATTN: CHARLES W KOLIFRATH         PHONE NO : 978 421 9786   
269 MILL ROAD                     SE DECISION MADE: 25-SEP-12
CHELMSFORD MA 01824 4105          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FAXITRON SPECIEN RADIOGRAPHY SYSTEM
FAXITRON BIOPTICS LLC             510(k) NO: K122428(TRADITIONAL)
ATTN: DOUGLAS C WIEGMAN           PHONE NO : 847 276 3765   
3440 E. BRITANNIA DRIVE SUITE 150 SE DECISION MADE: 25-SEP-12
TUCSON AZ 85706                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TOSHIBA 3T 32CH HEAD SPEEDER COIL,
QUALITY ELECTRODYNAMICS           510(k) NO: K122638(TRADITIONAL)
ATTN: KATHLEEN  ARAS              PHONE NO : 440 481 2964   
700 BETA DRIVE SUITE 100          SE DECISION MADE: 25-SEP-12
MAYFIELD VILLAGE OH 44143 0000    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BENCOX FORET & BENCOX DELTA
CORENTEC CO., LTD                 510(k) NO: K121665(TRADITIONAL)
ATTN: J.S.  DANIEL                PHONE NO : 820 743933 819
11TH CHUNGHO TOWER 748-1 BANPO 1 DSE DECISION MADE: 25-SEP-12
SEOCHO GU, SEOUL    KS 137-040    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ATTAIN CLARITY 6225 VENOGRAM BALLOON CATHETER
MEDTRONIC INC.                    510(k) NO: K121219(TRADITIONAL)
ATTN: WENDY  SAUNDERS             PHONE NO : 763 526 8134   
8200 CORAL SEA STREET MS MVSII    SE DECISION MADE: 25-SEP-12
MOUNDS VIEW MN 55112              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DMRC NANOFLOW DMRC NANOCOMPOSITE EBOND SURE ETCH GEL SURE ETCH LIQUID
DANVILLE MATERIALS, INC.          510(k) NO: K121880(TRADITIONAL)
ATTN: LINDSAY  TILTON             PHONE NO : 925 973 0710   
3420 FOSTORIA WAY, SUITE A-200    SE DECISION MADE: 25-SEP-12
SAN RAMON CA 94583                510(k) STATEMENT

DEVICE: STERLING MEDICAL IMPULSE 3 STIMULATOR
ARMSTRONG INDUSTRIES, INC. DHA MED510(k) NO: K121305(TRADITIONAL)
ATTN: RALPH H ARMSTRONG           PHONE NO : 972 547 1400   
7290 VIRGINIA PARKWAY SUITE 3000  SE DECISION MADE: 25-SEP-12
MCKINNEY TX 75071                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CUSTOM CRANIOFACIAL IMPLANT (CCI)
KELYNIAM GLOBAL, INC.             510(k) NO: K121755(TRADITIONAL)
ATTN: NICHOLAS  BREAULT           PHONE NO : 800 280 8192   
97 River Rd STE A                 SE DECISION MADE: 25-SEP-12
Canton CT 06019                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERRAD (R) 100NX DUO CYCLE TEST PACK
ADVANCED STERILIZATION PRODUCTS   510(k) NO: K111391(TRADITIONAL)
ATTN: NANCY  CHU                  PHONE NO : 949 453 6435   
33 TECHNOLOGY DR.                 SE DECISION MADE: 26-SEP-12
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXSPIRON
RESPIRATORY MOTION, INC.          510(k) NO: K120087(TRADITIONAL)
ATTN: CHAS  BURR                  PHONE NO : 781 789 1646   
11 MYSTIC AVENUE                  SE DECISION MADE: 26-SEP-12
WINCHESTER MA 01890 2920          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ITERATIVE RECONSTRUCTION TECHNIQUE SOFTWARE APPLICATION
PHILIPS HEALTHCARE (CLEVELAND)    510(k) NO: K113483(TRADITIONAL)
ATTN: CHRISTINE  ANDERSON         PHONE NO : 440 483 7732   
595 MINER RD.                     SE DECISION MADE: 26-SEP-12
CLEVELAND OH 44143                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EMBRYOGEN
ORIGIO A/S                        510(k) NO: K120136(TRADITIONAL)
ATTN: ERIC  GRUFF                 PHONE NO : 858 735 0320   
15696 OAKSTAND ROAD               SE DECISION MADE: 26-SEP-12
POWAY CA 92064                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37
HITACHI ALOKA MEDICAL, LTD.       510(k) NO: K122341(TRADITIONAL)
ATTN:                             PHONE NO : 
10 FAIRFIELD BLVD.                SE DECISION MADE: 26-SEP-12
WALLINGFORD CT CT 06492 7502      510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ATHEROEDGE
ATHEROPOINT LLC                   510(k) NO: K122022(TRADITIONAL)
ATTN: JASJIT S SURI               PHONE NO : 916 749 5628   
208 OTTER GLEN CT                 SE DECISION MADE: 26-SEP-12
ROSEVILLE CA 95661                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COOLRAIL LINEAR PEN MODEL MCRI
ATRICURE, INC.                    510(k) NO: K122611(SPECIAL)
ATTN: JIM  LUCKY, RAC             PHONE NO : 513 755 5754   
6217 CENTRE PARK DRIVE            SE DECISION MADE: 26-SEP-12
WEST CHESTER OH 45069             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DURABLUE STERILIZATION WRAP, MODEL NUMBERS CH100, CH200, CH300, CH400, CH500 AND CH600, STERRAD NX STERILIZATION
CARDINAL HEALTH 200, LLC          510(k) NO: K122507(TRADITIONAL)
ATTN: LAVENIA  FORD               PHONE NO : 847 887 3323   
1430 WAUKEGAN ROAD                SE DECISION MADE: 26-SEP-12
WAUKEGAN IL 60085                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ELECTRONIC STETHOSCOPE
SHARP CORPORATION                 510(k) NO: K121144(TRADITIONAL)
ATTN: DIANE  RUTHERFORD           PHONE NO : 972 480 9554   
1201 RICHARDSON DRIVE SUITE 280   SE DECISION MADE: 26-SEP-12
RICHARDSON TX 75080               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORACLE LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM
ACCEL SPINE                       510(k) NO: K121567(TRADITIONAL)
ATTN: DANIEL  CHON                PHONE NO : 800 713 9489   
14850 Quorum Dr Ste 220           SE DECISION MADE: 26-SEP-12
Dallas TX 75254                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SHORT LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT MODEL 3017-000 (LEFT) AND 3018-000 (RIGHT); 6 HOLE MEDIUM MIDSHAFT
ADVANCED ORTHOPAEDIC SOLUTIONS, IN510(k) NO: K122623(SPECIAL)
ATTN: ALLYSON  PARKS              PHONE NO : 310 533 9966   
386 BEECH AVENUE UNIT B6          SE DECISION MADE: 26-SEP-12
TORRANCE CA 90501                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FREEDOM ND: YAG LASER SYSTEM
LUTRONIC CORPORATION              510(k) NO: K113843(TRADITIONAL)
ATTN: JHUNG WON  VOJIR            PHONE NO : 215 205 2219   
6 NESHAMINY INTERPLEX, SUITE 207  SE DECISION MADE: 27-SEP-12
TREVOSE PA 19053                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RAPICIDE OPA-28
MINNTECH CORP.                    510(k) NO: K120306(TRADITIONAL)
ATTN: BRENT  GREIGER, MS, RAC     PHONE NO : 763 553 3300   
14605 28TH AVE. NORTH             SE DECISION MADE: 27-SEP-12
MINNEAPOLIS MN 55447              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
CONFORMIS, INC.                   510(k) NO: K122033(TRADITIONAL)
ATTN: AMITA S SHAH                PHONE NO : 781 345 9164   
11 NORTH AVENUE                   SE DECISION MADE: 27-SEP-12
BURLINGTON MA 01803               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EASYONE PRO RESPIRATORY TESTING DEVICE
NDD MEDIZITECHNIK AG              510(k) NO: K120635(TRADITIONAL)
ATTN: GERARD  MASIELLO            PHONE NO : 978 470 0923   
TWO DUNDEE PARK                   SE DECISION MADE: 27-SEP-12
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TYPE 1077 ACCUSCREEN
GN OTOMETRICS                     510(k) NO: K122067(TRADITIONAL)
ATTN: TOM  RINIKER                PHONE NO : 612 865786 2
HOERSKAETTEN 9                    SE DECISION MADE: 27-SEP-12
TAATRUP    DA DK-2630             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETS
TOGO MEDIKIT CO., LTD.            510(k) NO: K121504(TRADITIONAL)
ATTN: HEATHER  CRAWFORD           PHONE NO : 512 327 9997   
611 WEST 5TH STREET               SE DECISION MADE: 27-SEP-12
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WITHINGS, SMART BODY SCALE
ZHONGSHAN TRANSTEK ELECTRONICS CO.510(k) NO: K121971(SPECIAL)
ATTN: LEO  WANG                   PHONE NO : 862 886 083300
NO. 1 FANGHUA STREET HI-TECH DISTRSE DECISION MADE: 27-SEP-12
CHENGDU, SICHUAN    CH 610041     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PMT BONE SCREWS
PROVIDENCE MEDICAL TECHNOLOGY, INC510(k) NO: K121713(TRADITIONAL)
ATTN: GLEN  MANGSETH              PHONE NO : 415 923 9376   
201 Spear St Ste 1310             SE DECISION MADE: 27-SEP-12
San Francisco CA 94105            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K122096(TRADITIONAL)
ATTN: LEIGH  SPOTTEN              PHONE NO : 424 218 8738   
2151 E. GRAND AVE.                SE DECISION MADE: 27-SEP-12
EL SEGUNDO CA 90245               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
SHANDONG JUNFENG INDUSTRIES CO., L510(k) NO: K122266(TRADITIONAL)
ATTN: CHU  XIAOAN                 PHONE NO : 861 082 387441
ROOM 1606 BLDG. 1. JIANXIANG YUAN SE DECISION MADE: 27-SEP-12
BEIJING    CH 100083              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PEERSCOPE SYSTEM
PEERMEDICAL                       510(k) NO: K120289(TRADITIONAL)
ATTN: DAN  LAOR                   PHONE NO : 972 482 46632
6 SIRENI                          SE DECISION MADE: 28-SEP-12
HAIFA    IS 32972                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BAUSCH & LOMB IOL INJECTOR
BAUSCH & LOMB, INC.               510(k) NO: K113852(TRADITIONAL)
ATTN: JASON  SMITH                PHONE NO : 800 393 6642   
30 ENTERPRISE SUITE 450           SE DECISION MADE: 28-SEP-12
ALISO VIEJO CA 92656              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET
NIPRO MEDICAL CORPORATION         510(k) NO: K112628(SPECIAL)
ATTN: JESSICA  OSWALD             PHONE NO : 305 599 7174   
3150 N.W. 107TH AVE.              SE DECISION MADE: 28-SEP-12
MIAMI FL 33172                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MPACT EXTENSION
MEDACTA INTERNATIONAL             510(k) NO: K122641(SPECIAL)
ATTN: ADAM  GROSS                 PHONE NO : 805 437 7085   
4725 CALLE QUETZAL, UNIT B        SE DECISION MADE: 28-SEP-12
CAMARILLO CA 93012                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL EYE-FUNDUS CAMERA
MEDIMAGING INTEGRATED SOLUTIONS, I510(k) NO: K120982(TRADITIONAL)
ATTN: CHIH-LU  HSU                PHONE NO : 886 357 98860
1F, NO. 7, R&D RD II HSUNCHU SCIENSE DECISION MADE: 28-SEP-12
HSINCHU    CH 30076               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WALLFLEXTM BILIARY RX STENT SYSTEM (UNCOVERED, PARTIALLY COVERED, AND FULLY COVERED) WALLFLEXTM BILIARY TRANSHEPATIC STE
BOSTON SCIENTIFIC CORPORATION     510(k) NO: K122072(TRADITIONAL)
ATTN: LAURIE  PANNELLA            PHONE NO : 508 683 4872   
100 BOSTON SCIENTIFIC WAY         SE DECISION MADE: 28-SEP-12
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOMNOGUARD SP SOFT
TOMED DR. TOUSSAINT GMBH          510(k) NO: K121761(TRADITIONAL)
ATTN: SCOTT  WHITCOMB             PHONE NO : 603 968 3172   
854 US ROUTE 3                    SE DECISION MADE: 28-SEP-12
HOLDERNESS NH 03245               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EPIC 10
BIOLASE TECHNOLOGY, INC.          510(k) NO: K121286(SPECIAL)
ATTN: ROBERT  YANG                PHONE NO : 949 361 1200   
4 CROMWELL                        SE DECISION MADE: 28-SEP-12
IRVINE CA 92618 1816              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACUSON
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K122825(TRADITIONAL)
ATTN: SHELLY  PEARCE              PHONE NO : 650 694 5988   
685 East Middlefield Road         SE DECISION MADE: 28-SEP-12
Mountain View CA 94043            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: EXACTRAC VERO
BRAINLAB AG                       510(k) NO: K122451(TRADITIONAL)
ATTN: ALEXANDER  SCHWIERSCH       PHONE NO : 004 989 9915680
KAPELLENSTRASSE 12                SE DECISION MADE: 28-SEP-12
FELDKIRCHEN    GM 85622           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GMK NARROW
MEDACTA INTERNATIONAL             510(k) NO: K122232(SPECIAL)
ATTN: ADAM  GROSS                 PHONE NO : 805 437 7085   
4725 CALLE QUETZAL, UNIT B        SE DECISION MADE: 28-SEP-12
CAMARILLO CA 93012                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 14.5-16.0 FRENCH CUFFED CATHETER REMOVAL DEVICE, SYMMETRY SURGICAL SINGEL USE
SYMMETRY MEDICAL                  510(k) NO: K122263(TRADITIONAL)
ATTN: HANNAH  FOLEY               PHONE NO : 615 964 5509   
3034 OWEN DRIVE                   SE DECISION MADE: 28-SEP-12
ANTIOCH TN 37013                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BRIGHT RESTORATIVE MATERIALS
DMP LTD                           510(k) NO: K121915(TRADITIONAL)
ATTN: DIMITRIS  PRANTSIDIS        PHONE NO : 003 022990 23041
KALYVION AVENUE MARKOPOULO INDUSTRSE DECISION MADE: 28-SEP-12
MARKOPOULO, ATTIKI    GR 19003    510(k) STATEMENT

DEVICE: OVERTUBE ENDOSCOPIC ACCESS SYSTEM
APOLLO ENDOSURGERY, INC.          510(k) NO: K122270(TRADITIONAL)
ATTN: HEATHER  CRAWFORD, RAC      PHONE NO : 512 328 9990   
7000 BEE CAVES RD. SUITE 350      SE DECISION MADE: 28-SEP-12
AUSTIN TX 78746                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC.     510(k) NO: K122433(SPECIAL)
ATTN: CHRIS  MCKEE                PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 28-SEP-12
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BESIDE RESPIRATORY PATIENT MONITORING SYSTEM BESIDE RESIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTWARE
COVIDIEN                          510(k) NO: K121806(ABBREVIATED)
ATTN: ELIZABETH  MALO             PHONE NO : 303 305 2763   
6135 GUNBARREL AVE.               SE DECISION MADE: 28-SEP-12
BOULDER CO 80301                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EZ-BLOCKER
EZ-BLOCKER B.V.                   510(k) NO: K121462(TRADITIONAL)
ATTN: LEWIS  WARD                 PHONE NO : 303 530 3279   
4655 KIRKWOOD COURT               SE DECISION MADE: 28-SEP-12
BOULDER CO 80301                  510(k) SUMMARY AVAILABLE FROM FDA


                                                 TOTAL 510(k)s THIS PERIOD   246                                     
                                                 TOTAL WITH SUMMARIES        238                                     
                                                 TOTAL WITH STATEMENTS        8