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Medical Devices

January 2012 510(k) Clearances

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


DEVICE: DNE EXTERNAL FIXATION SYSTEM
D.N.E., LLC                       510(k) NO: K113106(TRADITIONAL)
ATTN: J.D.  WEBB                  PHONE NO : 512 388 0199   
1001 OAKWOOD BLVD                 SE DECISION MADE: 04-JAN-12
ROUND ROCK TX 78681               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL
INSTRUMENTATION LABORATORY CO.    510(k) NO: K113211(TRADITIONAL)
ATTN: JACQUELINE  EMERY           PHONE NO : 781 861 4350   
180 HARTWELL ROAD                 SE DECISION MADE: 04-JAN-12
BEDFORD MA 01730                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NORMATEC MVP
NORMATEC INDUSTRIES, LP           510(k) NO: K112890(TRADITIONAL)
ATTN: JONATHAN  KAHAN             PHONE NO : 202 637 5794   
555 THIRTEENTH STREET, NW         SE DECISION MADE: 04-JAN-12
WASHINGTON DC 20016               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AVIVO MOBILE PATIENT MANAGEMENT
CORVENTIS, INC.                   510(k) NO: K113187(ABBREVIATED)
ATTN: KATHLEEN  LUNDBERG          PHONE NO : 651 925 3807   
1410 ENERGY PARK DRIVE SUITE 1    SE DECISION MADE: 04-JAN-12
Saint Paul MN 55108               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NOVATION INTEGRIP ACETABULAR AUGMENTS, GROUPS 4 AND 5
EXACTECH, INC.                    510(k) NO: K113609(SPECIAL)
ATTN: VLADISLAVA  ZAITSEVA        PHONE NO : 352 377 1140   
2320 N.W. 66TH CT.                SE DECISION MADE: 04-JAN-12
GAINESVILLE FL 32653              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DYNA LOCKING CANNULATED SCREW
U&I CORP.                         510(k) NO: K112240(TRADITIONAL)
ATTN: GYEONG-JE  KWON             PHONE NO : 82 318 520102
529-1 YONGHYN-DONG                SE DECISION MADE: 04-JAN-12
UIJUNGBU, KYUNGGI-DO    KS 480-050510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FOCUS MIS SYSTEM
L & K BIOMED CO., LTD             510(k) NO: K112643(TRADITIONAL)
ATTN: HEE K JOO                   PHONE NO : 822 262 41471
ROOM 1104, ACE HIGH-END TOWER3 371SE DECISION MADE: 04-JAN-12
SEOUL    KS 153803                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIGBOSS CATHETER
BRIDGEPOINT MEDICAL               510(k) NO: K113589(SPECIAL)
ATTN: JILL  MUNSINGER             PHONE NO : 763 225 8500   
13355 10TH AVE N, SUITE #110      SE DECISION MADE: 04-JAN-12
PLYMOUTH MN 55441                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CERTUS 140 2.45GHZ ABLATION SYSTEM
NEUWAVE MEDICAL, INC.             510(k) NO: K113237(TRADITIONAL)
ATTN: DAN  KOSEDNAR               PHONE NO : 608 512 1592   
3529 Anderson St                  SE DECISION MADE: 04-JAN-12
Madison WI 53704                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL X-RAY IMAGING SYSTEM
RF CO., LTD                       510(k) NO: K111103(TRADITIONAL)
ATTN: KOJI  KUBO                  PHONE NO : 81 359 816880
6-5-3 BEAUNE HONKOMAGOME 2F HONKOMSE DECISION MADE: 05-JAN-12
BUNKYO-KU, TOKYO    JA 113-0021   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORTHOSCAN MOBILE DI MINI C-ARM
ORTHOSCAN, INC.                   510(k) NO: K113708(TRADITIONAL)
ATTN: CHRIS  EAVES                PHONE NO : 480 503 8010   
8212 E. EVANS ROAD                SE DECISION MADE: 05-JAN-12
SCOTTSDALE AZ 85260               510(k) STATEMENT
                                  THIRD PARTY REVIEW

DEVICE: NMI 2.8 MICROCATHETER
NAVILYST MEDICAL, INC.            510(k) NO: K113638(SPECIAL)
ATTN: WANDA  CARPINELLA           PHONE NO : 508 658 7929   
26 FOREST STREET                  SE DECISION MADE: 05-JAN-12
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROSPERA PRO-I, PRO-II AND PRO-III NEGATIVE PRESSURE WOUND THERAPY SYSTEM
MEDICA-RENTS CO., LTD.            510(k) NO: K112458(SPECIAL)
ATTN: DINA L WEISSMAN, J.D.       PHONE NO : 203 954 9109   
P.O. BOX 205                      SE DECISION MADE: 05-JAN-12
DERBY CT 06418                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STRYKER UNIVERSAL NEURO 3 SYSTEM
STRYKER                           510(k) NO: K112557(TRADITIONAL)
ATTN: ROB  YAMASHITA              PHONE NO : 269 389 4258   
750 TRADE CENTRE WAY STE 200      SE DECISION MADE: 05-JAN-12
PORTAGE MI 49002                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VALET MICRO CATHETER
VOLCANO CORPORATION               510(k) NO: K112035(TRADITIONAL)
ATTN: LISA  QUAGLIA               PHONE NO : 978 439 3586   
1 FORTUNE DRIVE                   SE DECISION MADE: 05-JAN-12
BILLERICA MA 01821                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM
NOVA BIOMEDICAL CORPORATION       510(k) NO: K112955(TRADITIONAL)
ATTN: PAUL W MACDONALD            PHONE NO : 781 894 0800   
200 Prospect St                   SE DECISION MADE: 05-JAN-12
WALTHAM MA 02454                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HALO60 ABLATION CATHETER
BARRX MEDICAL, INC.               510(k) NO: K112454(SPECIAL)
ATTN: DAWN  CHANG                 PHONE NO : 408 328 7357   
540 OAKMEAD PARKWAY               SE DECISION MADE: 05-JAN-12
Sunnyvale CA 94085                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROMOS MODULAR SHOULDER SYSTEM
SMITH & NEPHEW, INC.              510(k) NO: K113012(TRADITIONAL)
ATTN: MEGAN  BEVILL               PHONE NO : 901 399 5340   
1450 BROOKS ROAD                  SE DECISION MADE: 05-JAN-12
MEMPHIS TN 38116                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELECTRO-GEL
ELECTRO-CAP INTL., INC.           510(k) NO: K111717(TRADITIONAL)
ATTN: AMY B SWALLOWS              PHONE NO : 937 456 6099   
1011 WEST LEXINGTON RD.           SE DECISION MADE: 05-JAN-12
EATON OH 45320                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMITH & NEPHEW INC. UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM INSTRUMENTS
SMITH & NEPHEW, INC.              510(k) NO: K113038(TRADITIONAL)
ATTN: GINO  ROUSS                 PHONE NO : 901 399 6707   
1450 BROOKS RD.                   SE DECISION MADE: 05-JAN-12
MEMPHIS TN 38116                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APEX ARC HIP STEM
OMNILIFE SCIENCE INC.             510(k) NO: K113242(SPECIAL)
ATTN: CHRISTINE  NASSIF           PHONE NO : 774 226 1871   
50 O'CONNELL WAY                  SE DECISION MADE: 05-JAN-12
EAST TAUNTON MA 02718             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AVITA INFRARED THEROMETER WITH BLUETOOTH
AVITA CORPORATION                 510(k) NO: K110559(TRADITIONAL)
ATTN: JENNIFER  REICH             PHONE NO : 928 863 8140   
2904 N. BOLDT DR.                 SE DECISION MADE: 06-JAN-12
FLAGSTAFF AZ 86001                510(k) STATEMENT

DEVICE: MTA ANGELUS
ANGELUS INDUSTRIA DE PRODUCTOS ODO510(k) NO: K112046(TRADITIONAL)
ATTN: LINDA K SCHULZ              PHONE NO : 858 792 1235   
11234 EL CAMINO REAL, SUITE 200   SE DECISION MADE: 06-JAN-12
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: U-RIGHT TD-1240 THERMOMETER
TAIDOC TECHNOLOGY CORPORATION     510(k) NO: K113159(SPECIAL)
ATTN: LINDA  KO                   PHONE NO : 886 266 258188
3F,5F, No.127, Wugong 2nd Rd. WuguSE DECISION MADE: 06-JAN-12
New Taipei City    TW 24888       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RADIANCE
GMV AEROSPACE AND DEFENCE S.A.    510(k) NO: K112060(TRADITIONAL)
ATTN: WILLIAM  GREENROSE          PHONE NO : 603 369 3550   
220 RIVER ROAD                    SE DECISION MADE: 06-JAN-12
CLAREMONT NH 03743                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IVAS 20MM (10 GAUGE) BALLOON CATHETER
STRYKER INSTRUMENTS, INSTRUMENTS D510(k) NO: K113477(TRADITIONAL)
ATTN: CHRISTINA  MCKEE            PHONE NO : 269 389 4086   
4100 EAST MILHAM AVE.             SE DECISION MADE: 06-JAN-12
KALAMAZOO MI 49001                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER
MATERIALISE N.V.                  510(k) NO: K112301(TRADITIONAL)
ATTN: ALEXANDRA  RAZZHIVINA       PHONE NO : 321 639 6280
15 TECHNOLOGIELAAN                SE DECISION MADE: 06-JAN-12
LEUVEN    BE 3001                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SONOTT FLOWLAB(R)
EM-TEC GMBH                       510(k) NO: K111730(ABBREVIATED)
ATTN: BERNHARD  BRAND             PHONE NO : 49 880 6923621
LERCHENBERG 20                    SE DECISION MADE: 06-JAN-12
FINNING    GM 86923               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: APTUS WRIST ARTHRODESIS PLATES
MEDARTIS AG                       510(k) NO: K112169(TRADITIONAL)
ATTN: KEVIN A THOMAS              PHONE NO : 858 792 1235   
11234 EL CAMINO REAL, SUITE 200   SE DECISION MADE: 06-JAN-12
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TOUCHPACS SUITE
TOUCH MEDICAL SOLUTIONS INC.      510(k) NO: K112008(TRADITIONAL)
ATTN: JAMES  OWEN                 PHONE NO : 336 413 6967   
3455 UNIVERSITY PKWY              SE DECISION MADE: 06-JAN-12
WINSTON-SALEM NC 27106 4109       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MIRAGE QUATTRO
RESMED LTD.                       510(k) NO: K113127(SPECIAL)
ATTN: DAVID  D'CRUZ               PHONE NO : 858 836 5984   
9001 SPECTRUM CENTER BLVD.        SE DECISION MADE: 06-JAN-12
SAN DIEGO CA 92123                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GLUCOSE TEST SYSTEM
ROCHE DIAGNOSTICS                 510(k) NO: K113137(SPECIAL)
ATTN: KHONESAVANH  SAYSANA        PHONE NO : 317 521 7593   
9115 HAGUE ROAD                   SE DECISION MADE: 06-JAN-12
INDIANAPOLIS IN 46250 0416        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K112523(TRADITIONAL)
ATTN: GARO  MIMARYAN              PHONE NO : 914 524 3270   
511 BENEDICT AVE.                 SE DECISION MADE: 06-JAN-12
TARRYTOWN NY 10591                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNGO.MR ONCO, SYNGO.MR 3D LESION SEGMENTATION, SYNGO.MR ONCO ENGINE
SIEMENS MEDICAL SYSTEMS USA       510(k) NO: K111861(TRADITIONAL)
ATTN: NADIA  SOOKDEO              PHONE NO : 610 448 4918   
53 VALLEY STREAM PARKWAY          SE DECISION MADE: 06-JAN-12
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LABRALINK SUTURE ANCHOR WITH INSERTER, 2.9MM PER-LOADED WITH ONE (1) AND (2) #2 UHMWPE SUTURE
CAYENNE MEDICAL, INC.             510(k) NO: K112960(TRADITIONAL)
ATTN: KERESHMEH  SHAHRIARI        PHONE NO : 480 502 3661   
16597 N. 92ND STREET SUITE 101    SE DECISION MADE: 09-JAN-12
SCOTTSDALE AZ 85260               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEUROTECH PLUS
BIO-MEDICAL RESEARCH, LTD.        510(k) NO: K112258(TRADITIONAL)
ATTN: ANNE-MARIE  KEENAN          PHONE NO : 353 91 774316
BMR HOUSE PARKMORE BUSINESS PARK, SE DECISION MADE: 09-JAN-12
GALWAY    EI EI                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APNEA RISK EVALUATION SYSTEM (ARES)
ADVANCED BRAIN MONITORING, INC.   510(k) NO: K112514(TRADITIONAL)
ATTN: ADRIENNE  LENZ              PHONE NO : 760 720 0099   
2511 FOX RIVER CIRCLE             SE DECISION MADE: 09-JAN-12
WAUKESHA WI 53189                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHECEL DURA REPLACEMENT DEVICES
SYNTHES                           510(k) NO: K113071(TRADITIONAL)
ATTN: ANDREA M TASKER             PHONE NO : 610 719 6920   
1301 GOSHEN PARKWAY               SE DECISION MADE: 09-JAN-12
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRACER IMPLANTATION KIT, INDEX IMPLANTATION KIT
NAVOTEK MEDICAL LTD               510(k) NO: K110971(TRADITIONAL)
ATTN: STEVEN B DATLOF             PHONE NO : 267 675 4613   
1835 MARKET ST. 29TH FLOOR        SE DECISION MADE: 10-JAN-12
PHILADELPHIA PA 19103             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PREPEX SYSTEM
CIRC MEDTECH                      510(k) NO: K103695(TRADITIONAL)
ATTN: SHOSHANA  FRIEDMAN          PHONE NO : 704 899 0092   
1914 J.N. PEASE PLACE             SE DECISION MADE: 10-JAN-12
CHARLOTTE NC 28262                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROPATCH SOFT TISSUE REPAIR MATRIX
CRYOLIFE, INC.                    510(k) NO: K110581(TRADITIONAL)
ATTN: BRYAN  BROSSEAU             PHONE NO : 770 419 3355   
1655 ROBERTS BLVD., N.W.          SE DECISION MADE: 10-JAN-12
KENNESAW GA 30144                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALEUTIAN SYSTEM
K2M, INC.                         510(k) NO: K113138(SPECIAL)
ATTN: NANCY  GIEZEN               PHONE NO : 703 777 3155   
751 MILLER DR.,SE                 SE DECISION MADE: 10-JAN-12
LEESBURG VA 20175                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DSS STABILIZATION SYSTEM
PARADIGM SPINE, LLC               510(k) NO: K113625(SPECIAL)
ATTN: MICHELLE  MCDONOUGH         PHONE NO : 202 552 5800   
1331 H STREET NW 12TH FLOOR       SE DECISION MADE: 10-JAN-12
WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VOLUSON E6/E8/E8EXPERT/E10
GE HEALTHCARE                     510(k) NO: K113758(SPECIAL)
ATTN: BRYAN  BEHN                 PHONE NO : 414 721 4214   
9900 INNOVATION DRIVE             SE DECISION MADE: 10-JAN-12
WAUWATOSA WI 53226                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: I-ENDO DUAL
SATELEC-ACTEON GROUP              510(k) NO: K111623(TRADITIONAL)
ATTN: RICK  ROSATI                PHONE NO : 856 222 9988   
124 GAITHER DRIVE , SUITE 140     SE DECISION MADE: 10-JAN-12
MT LAUREL NJ 08054                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CORTRAK ENTERAL ACCESS DEVICE
CORPAK MEDSYSTEMS                 510(k) NO: K113351(SPECIAL)
ATTN: STEPHANIE  WASIELEWSKI      PHONE NO : 847 403 3484   
1001 ASBURY DR.                   SE DECISION MADE: 10-JAN-12
BUFFALO GROVE IL 60089            510(k) STATEMENT

DEVICE: NEO TITANIUM MESH, CTI-MEM
NEOBIOTECH CO., LTD.              510(k) NO: K111761(TRADITIONAL)
ATTN: RON  ARKIN                  PHONE NO : 770 565 6166   
1733 CANTON LANE                  SE DECISION MADE: 10-JAN-12
MARIETTA GA 30006                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FINE JECT INSULIN PEN NEEDLE
TWOBIENS CO., LTD.                510(k) NO: K112332(TRADITIONAL)
ATTN: PETER  CHUNG                PHONE NO : 412 687 3976   
300 ATWOOD                        SE DECISION MADE: 10-JAN-12
PITTSBURGH PA 15213               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GLADIATOR PTA BALLOON DILATION CATHETER
BOSTON SCIENTIFIC                 510(k) NO: K113681(SPECIAL)
ATTN: AMBER  JOHNSON              PHONE NO : 763 494 2643   
ONE SCIMED PLACE                  SE DECISION MADE: 11-JAN-12
MAPLE GROVE MN 55311              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUSPENSION CLAVICLE FRACTURE REPAIR SYSTEM
SUSPENSION ORTHOPAEDIC SOLUTIONS, 510(k) NO: K113405(SPECIAL)
ATTN: CURTIS  RAYMOND             PHONE NO : 203 922 0105   
80 SHELTON TECHNOLOGY CENTER      SE DECISION MADE: 11-JAN-12
SHELTON CT 06484                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SANICLAVE 200
ALTERNATIVE PIONEERING RESEARCH AN510(k) NO: K112811(TRADITIONAL)
ATTN: ISAAC  ERICKSON             PHONE NO : 651 353 7806   
17319 LAKE BLVD.                  SE DECISION MADE: 11-JAN-12
SHAFER MN 55074                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
BOSTON SCIENTIFIC CORPORATION     510(k) NO: K113651(SPECIAL)
ATTN: HARLAN  JONES               PHONE NO : 763 255 0027   
ONE SCIMED PLACE                  SE DECISION MADE: 11-JAN-12
MAPLE GROVE MN 55311              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERIS STEAM PI
STERIS CORPORATION                510(k) NO: K112256(ABBREVIATED)
ATTN: ROBERT  SULLIVAN            PHONE NO : 440 392 7695   
5960 HEISLEY ROAD                 SE DECISION MADE: 11-JAN-12
MENTOR OH 44060                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REPROCESSED HARMONIC SCALPEL
STERILMED, INC.                   510(k) NO: K111794(TRADITIONAL)
ATTN: ONYA  DENDINGER             PHONE NO : 763 488 3410   
11400 73RD AVE. NORTH             SE DECISION MADE: 11-JAN-12
MAPLE GROVE MN 55369 5562         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNERGY TISSUE MATRIX
SYNOVIS ORTHOPEDIC & WOUNDCARE    510(k) NO: K113460(TRADITIONAL)
ATTN: AMY  BOUCLY                 PHONE NO : 949 502 3240   
6 Jenner, Suite 150               SE DECISION MADE: 11-JAN-12
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY
BIOMET MANUFACTURING CORP.        510(k) NO: K113069(TRADITIONAL)
ATTN: PATRICIA S BERES            PHONE NO : 574 267 6639   
56 BELL DRIVE                     SE DECISION MADE: 11-JAN-12
WARSAW IN 46580                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AP-1000 BLOOD GLUCOSE MONITORING SYSTEM, MODEL AP-1000, MAJOR GLUCOSE CONTROL SOLUTION
BESTGEN BIOTECH CORP.             510(k) NO: K100437(TRADITIONAL)
ATTN: STEVEN  SHEN                PHONE NO : 886 282 272188
7F, NO.186, JIAN 1ST RD.,         SE DECISION MADE: 12-JAN-12
JHONGHE CITY, TAIPEI COUNTY    TW 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CUROS PORT PROTECTOR
IVERA MEDICAL, INC.               510(k) NO: K111992(TRADITIONAL)
ATTN: DON  CANAL                  PHONE NO : 888 861 8228   
2731 LOKER AVENUE WEST            SE DECISION MADE: 12-JAN-12
CARLSBAD CA 92010                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FUNNEL GUIDE CATHETER MODEL G1020608
LAZARUS EFFECT, INC               510(k) NO: K102439(TRADITIONAL)
ATTN: CARRIE  NEUBERGER           PHONE NO : 415 640 3377   
767 EL SOLYO HEIGHTS DR           SE DECISION MADE: 12-JAN-12
FELTON CA 95018                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ABSOLUTE WHITE LIGHT
DR. FRESH, INC.                   510(k) NO: K110888(TRADITIONAL)
ATTN: M. JOYCE  HEINRICH          PHONE NO : 713 734 4433   
12101 CULLEN BLVD                 SE DECISION MADE: 12-JAN-12
HOUSTON TX 77047 1131             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIFESHIELD VISION INFUSION SET WITH PRE-PIERCED RESEAL
HOSPIRA,INC.                      510(k) NO: K113683(SPECIAL)
ATTN: KAREN  KEENER               PHONE NO : 224 212 5316   
375 N. FIELD DR.                  SE DECISION MADE: 12-JAN-12
Lake Forest IL 60045              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CABLECAP
SENSORMED                         510(k) NO: K113330(TRADITIONAL)
ATTN: WILLIAM  MILAM              PHONE NO : 865 216 6307   
2450 EJ CHAPMAN DR.,              SE DECISION MADE: 12-JAN-12
KNOXVILLE TN 37996                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTED
THE PROCTER & GAMBLE COMPANY      510(k) NO: K113699(SPECIAL)
ATTN: KATHLEEN  BLIESZNER         PHONE NO : 513 634 3168   
6110 CANTER HILL AVENUE           SE DECISION MADE: 12-JAN-12
CINCINNATI OH 45224               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SYSTEM
THE ORTHOPAEDIC IMPLANT COMPANY   510(k) NO: K113123(TRADITIONAL)
ATTN: KEVIN  WALLS                PHONE NO : 720 962 5412   
5401 S. COTTONWOOD CT.            SE DECISION MADE: 12-JAN-12
GREENWOOD VILLAGE CO 80121        510(k) STATEMENT

DEVICE: LUCEA LED SURGICAL LIGHT SYSTEM
MAQUET SAS                        510(k) NO: K113679(SPECIAL)
ATTN: WHITNEY  TORNING            PHONE NO : 973 709 7994   
45 BARBOUR POND DRIVE             SE DECISION MADE: 12-JAN-12
WAYNE NJ 07470                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CASPIAN
K2M, INC.                         510(k) NO: K113654(SPECIAL)
ATTN: NANCY  GIEZEN               PHONE NO : 703 777 3155   
751 MILLER DR.,SE                 SE DECISION MADE: 12-JAN-12
LEESBURG VA 20175                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING
EDWARDS LIFESCIENCES, LLC.        510(k) NO: K113667(SPECIAL)
ATTN: KAREN  JONES                PHONE NO : 801 565 6231   
12050 LONE PEAK PKWY              SE DECISION MADE: 12-JAN-12
DRAPER UT 84020                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACUTE INNOVATIONS MODULAR RIBLOC SYSTEM
ACUTE INNOVATIONS LLC             510(k) NO: K113318(TRADITIONAL)
ATTN: MARIAH  KNIGHT              PHONE NO : 503 686 7200   
21421 NW JACOBSON RD. SUITE 700   SE DECISION MADE: 12-JAN-12
HILLSBORO OR 97124                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRYLY AUTOMATIC WRIST BLOOD PRESSURE MONITOR
TRULY INSTRUMENT CO., LTD.        510(k) NO: K113085(ABBREVIATED)
ATTN: MAX  WONG                   PHONE NO : 626 284 3033   
2620  CONCORD AVENUE SUITE 106    SE DECISION MADE: 12-JAN-12
ALHAMBRA CA 91803                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CRY-ACTRACKERCAM
BRYMILL CRYOGENIC CYSTEMS         510(k) NO: K110305(SPECIAL)
ATTN: CLAUDIO  RUSSO              PHONE NO : 860 875 2460   
BUILDING 2, 105 WINDERMERE AVE    SE DECISION MADE: 13-JAN-12
ELLINGTON CT 06029                510(k) STATEMENT

DEVICE: PDE PHOTODYNAMIC EYE
HAMAMATSU PHOTONICS, K.K.         510(k) NO: K110480(TRADITIONAL)
ATTN: JEFFREY K SHAPIRO           PHONE NO : 202 737 9633   
700 13TH STREET, NW SUITE 1200    SE DECISION MADE: 13-JAN-12
WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SLIM ONEBODY SYSTEM
DENTIUM CO., LTD.                 510(k) NO: K111162(ABBREVIATED)
ATTN: EUNKYUNG  SON               PHONE NO : 714 226 0229   
6761 KATELLA AVENUE CYPRESS       SE DECISION MADE: 13-JAN-12
CYPRESS CA 90630                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THE VENOUS ASSIST SYSTEM
DAESUNG MAREF CO., LTD.           510(k) NO: K112677(TRADITIONAL)
ATTN: DANIEL  NAM                 PHONE NO : 714 523 1592   
4568 WEST 1ST STREET SUITE 104    SE DECISION MADE: 13-JAN-12
LOS ANGELES CA 90004              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NNC SOLID ABUTMENT NNC TEMPORARY COPING FOR COLID ABUTMENT NNC TEMPORARY CAP FOR COLID ABUTMENT
STRAUMANN USA                     510(k) NO: K113410(SPECIAL)
ATTN: ELAINE  ALAN                PHONE NO : 978 747 2513   
60 MINUTEMAN ROAD                 SE DECISION MADE: 13-JAN-12
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SCEPTER XC OCCLUSION BALLOON CATHETER
MICRO VENTION, INC.               510(k) NO: K113698(SPECIAL)
ATTN: NAOMI  GONG                 PHONE NO : 714 247 8055   
1311 VALENCIA AVENUE              SE DECISION MADE: 13-JAN-12
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VARIOUS
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K112417(TRADITIONAL)
ATTN: DEEP  PAL                   PHONE NO : 508 977 3998   
325 PARAMOUNT DR.                 SE DECISION MADE: 13-JAN-12
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODE
RESPIRONICS CALIFORNIA, INC.      510(k) NO: K110083(TRADITIONAL)
ATTN: MARY  FUNK                  PHONE NO : 760 918 7328   
2271 COSMOS CT.                   SE DECISION MADE: 13-JAN-12
CARLSBAD CA 92130                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BABI PLUS NEONATAL RESUSCITATION BAG
A PLUS MEDICAL                    510(k) NO: K112852(TRADITIONAL)
ATTN: THOMAS C LOESCHER           PHONE NO : 760 930 4025   
5431 AVENIDA ENCINAS SUITE G      SE DECISION MADE: 13-JAN-12
CARLSBAD CA 92008                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VANTAGE TITAN 3T
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K113093(TRADITIONAL)
ATTN: PAUL  BIGGINS               PHONE NO : 714 730 5000   
2441 MICHELLE DRIVE               SE DECISION MADE: 13-JAN-12
TUSTIN CA 92781                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOEYE HD II
OLYMPUS AMERICA, INC.             510(k) NO: K111788(TRADITIONAL)
ATTN: STACY  ABBATIELLO KLUESNER  PHONE NO : 484 896 5405   
3500 CORPORATE PARKWAY            SE DECISION MADE: 13-JAN-12
CENTER VALLEY PA 18034 0610       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDI-SIS SYRINGE INFUSION SYSTEM
ACACIA, INC.                      510(k) NO: K111381(TRADITIONAL)
ATTN: FERGIE  FERGUSON            PHONE NO : 714 257 0470   
785 CHALLENGER STREET             SE DECISION MADE: 13-JAN-12
BREA CA 92821                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THERMO PAL INFRARED EAR THERMOMETER
DIGIO2 INTERNATIONAL CO., LTD.    510(k) NO: K112189(TRADITIONAL)
ATTN: JENNIFER  REICH             PHONE NO : 928 863 8140   
2904 N. BOLDT DRIVE               SE DECISION MADE: 13-JAN-12
FLAGSTAFF AZ 86001                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACQA
TEXAS MEDICAL IMAGING CONSULTANTS 510(k) NO: K113086(TRADITIONAL)
ATTN: TINSU  PAN                  PHONE NO : 713 409 3801   
4027 UNDERWOOD ST.                SE DECISION MADE: 13-JAN-12
HOUSTON TX 77025                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EVOLVE(R) HPD 980/1470NM MULTIWAVELENGTH DIODE LASER
BIOLITEC, INC.                    510(k) NO: K112013(TRADITIONAL)
ATTN: HARRY  HAYES                PHONE NO : 413 250 0779   
1349 MAIN ROAD                    SE DECISION MADE: 13-JAN-12
GRANVILLE MA 01034                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDICAL FACETS CORICAL SCREWS, MEDICAL FACETS CANCELLOUS SCREWS, MEDICAL FACETS HEADLESS COMPRESSION SCREWS, MEDICAL
MEDICAL FACETS                    510(k) NO: K112727(TRADITIONAL)
ATTN: GLENN A RUPP                PHONE NO : 704 562 7494   
1669 FEDERAL AVENUE               SE DECISION MADE: 13-JAN-12
GASTONIA NC 2805                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OPTIMA MR450W
GE MEDICAL SYSTEMS, LLC           510(k) NO: K113490(TRADITIONAL)
ATTN: ROBIN  MARTIN               PHONE NO : 262 312 1120   
3000 N GRANDVIEW BLVD.            SE DECISION MADE: 13-JAN-12
WAUKESHA WI 53188                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40
MAQUET CRITICAL CARE AB           510(k) NO: K112114(TRADITIONAL)
ATTN: WHITNEY  TORNING            PHONE NO : 973 709 7994   
45 BARBOUR POND DRIVE             SE DECISION MADE: 13-JAN-12
WAYNE NJ 07470                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEISENBERG EFFECT SHADES
3M ESPE AG                        510(k) NO: K120011(TRADITIONAL)
ATTN: DESI W SOEGIARTO            PHONE NO : 498 152 7001169
ESPE PLATZ                        SE DECISION MADE: 13-JAN-12
SEEFELD    GM 82229               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ABUTMENT FOR COMPETITIVE IMPLANT STRAUMANN BONE LEVEL CONNECTION
BIOMET 3I                         510(k) NO: K112730(SPECIAL)
ATTN: MAYANK  CHOUDHARY           PHONE NO : 561 776 6831   
4555 RIVERSIDE DRIVE              SE DECISION MADE: 13-JAN-12
PALM BEACH GARDENS FL 33410       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GENERATION C AESTHETIC SELF-LIGATING BRACKET SYSTEM
ORTHO TECHNOLOGY, INC             510(k) NO: K112707(TRADITIONAL)
ATTN: JODI  HUTCHINS              PHONE NO : 813 991 5896   
17401 COMMERCE PARK BLVD.         SE DECISION MADE: 13-JAN-12
TAMPA FL 33647                    510(k) STATEMENT

DEVICE: OSTEON II
GENOSS CO., LTD.                  510(k) NO: K112716(TRADITIONAL)
ATTN: SUNGWON  LEE                PHONE NO : 823 188 85100
1F GYEONGGI R&D CENTER 906-5 IUI-DSE DECISION MADE: 17-JAN-12
SUWON-SI YEONGTONG-GU, GYEONGG    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM
PATS CORP                         510(k) NO: K112441(TRADITIONAL)
ATTN: DANIEL  NAM                 PHONE NO : 714 523 1592   
4568 W. 1ST STREET SUITE 104      SE DECISION MADE: 17-JAN-12
LOS ANGELES CA 90004              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: K2M, PYRENEES CERVICAL PLATE SYSTEM
K2M, INC.                         510(k) NO: K113329(SPECIAL)
ATTN: NANCY  GIEZEN               PHONE NO : 703 777 3155   
751 MILLER DR.,SE                 SE DECISION MADE: 17-JAN-12
LEESBURG VA 20175                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL
BOSTON SCIENTIFIC CORPORATION     510(k) NO: K113101(TRADITIONAL)
ATTN: SUSAN  EICHLER-HUSTON       PHONE NO : 973 709 7487   
45 BARBOUR POND DRIVE             SE DECISION MADE: 17-JAN-12
WAYNE NJ 07470                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CUFFINK
CAYENNE MEDICAL, INC.             510(k) NO: K112814(TRADITIONAL)
ATTN: KERESHMEH  SHAHRIARI        PHONE NO : 480 502 3661   
16597 N.92ND ST. SUITE 101        SE DECISION MADE: 17-JAN-12
SCOTTSDALE AZ 85260               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HYPERION
CEFLA S.C. CEFLA DENTAL GROUP     510(k) NO: K113497(TRADITIONAL)
ATTN: MARISA  TESTA               PHONE NO : 390 542 653441
VIA BICOCCA N.14/C                SE DECISION MADE: 17-JAN-12
IMOLA    IT B040026               510(k) STATEMENT
                                  THIRD PARTY REVIEW

DEVICE: AERODR SYSTEM WITH P-21
KONICA MINOLTA MEDICAL & GRAPHIC, 510(k) NO: K113248(SPECIAL)
ATTN: RUSSELL  MUNVES             PHONE NO : 212 497 8208   
140 EAST 45TH ST., 25TH FLOOR TWO SE DECISION MADE: 17-JAN-12
NEW YORK NY 10017                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PEEK PREVAIL CERVICAL INTERBODY DEVICE
MEDTRONIC SOFAMOR DANEK           510(k) NO: K113252(TRADITIONAL)
ATTN: KRISTI  FRISCH              PHONE NO : 901 399 6221   
1800 PYRAMID PLACE                SE DECISION MADE: 17-JAN-12
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LEUCADIA AUTOLOK PEDICLE SCREW SYSTEM
PHYGEN, LLC                       510(k) NO: K113366(SPECIAL)
ATTN: HARTMUT  LOCH               PHONE NO : 949 752 7885   
2301 Dupont Drive, Suite 510      SE DECISION MADE: 17-JAN-12
Irvine CA 92612                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUTOSURE VOICE II PLUS, AUTOSURE PLUS BLOOD GLUCOSE TEST STRIPS,CONTREX PLUS III
APEX BIOTECHNOLOGY CORP.          510(k) NO: K113098(TRADITIONAL)
ATTN: HSUE-MEI  LEE               PHONE NO : 011 886 35641952
NO. 7, LI-HSIN ROAD V, HSINCHU SCISE DECISION MADE: 17-JAN-12
HSINCHU    TW 30078               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PARCUS 35 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS, PARCUS 45 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS
PARCUS MEDICAL, LLC               510(k) NO: K113730(SPECIAL)
ATTN: PAUL  VAGTS                 PHONE NO : 920 746 2972   
839 SOUTH NEENAH AVE.             SE DECISION MADE: 17-JAN-12
STURGEON BAY WI 54235             510(k) STATEMENT

DEVICE: QUASAR CALYPSO
SILVER BAY, LLC                   510(k) NO: K111286(TRADITIONAL)
ATTN: ROBERT  WAGNER              PHONE NO : 865 982 5552   
1131 ANTHEM VIEW LANE             SE DECISION MADE: 18-JAN-12
KNOXVILLE TN 37922                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AG-608N BLOOD GLUCOSE MONITORING SYSTEM
ANDON MEDICAL CO., LTD.           510(k) NO: K110017(TRADITIONAL)
ATTN: YI  LIU                     PHONE NO : 862 287 612426
NO. 04-23-3 AIRPORT INDUSTRIAL PARSE DECISION MADE: 18-JAN-12
TIANJIN    CH 300381              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MISSION U500 URINE ANALYZER
ACON LABORATORIES, INC.           510(k) NO: K111221(TRADITIONAL)
ATTN: QIYI  XIE                   PHONE NO : 858 875 8011   
10125 MESA RIM RD.                SE DECISION MADE: 18-JAN-12
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRIPORT, TRIPORT+, TRIPORT15, QUADPORT
ADVANCED SURGICAL CONCEPTS        510(k) NO: K111407(TRADITIONAL)
ATTN: JONATHAN S KAHAN            PHONE NO : 202 637 5794   
355 THIRTEENTH STREET, NW         SE DECISION MADE: 18-JAN-12
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL
ST. JUDE MEDICAL                  510(k) NO: K113773(TRADITIONAL)
ATTN: GEENA  GEORGE               PHONE NO : 818 493 2629   
15900 VALLEY VIEW COURT           SE DECISION MADE: 18-JAN-12
SYLMAR CA 91342                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AVITA ARM TYPE BLOOD PRESSURE MONITOR
AVITA CORPORATION                 510(k) NO: K112825(TRADITIONAL)
ATTN: JENNIFER  REICH             PHONE NO : 928 863 8140   
2904 N. BOLDT DR.                 SE DECISION MADE: 18-JAN-12
FLAGSTAFF AZ 86001                510(k) STATEMENT

DEVICE: POWDER FREE LATEX PATIENT EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM
TOP CALIBRE SDN BHD               510(k) NO: K112612(TRADITIONAL)
ATTN: TRACY  NGUI                 PHONE NO : 603 239 10516
1-1,2 JALAN SETIA PRIMA U13/S SETISE DECISION MADE: 18-JAN-12
SHAH ALAM, SELANGOR    MY 40170   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HANDHELD PULSE OXIMETER
BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K111494(SPECIAL)
ATTN: SUNNY  WANG                 PHONE NO : 861 088 204630
FLOOR 4, JINGYANG BLDG, NO.15 XIJISE DECISION MADE: 18-JAN-12
SHIJINGSHAN DISTRICT, BEIJING    C510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEGABEAM ENDOCULAR PROBE AND ASPIRATING ENDOCULAR PROBE
BIOLITEC MEDICAL DEVICES, INC     510(k) NO: K113792(TRADITIONAL)
ATTN: HARRY  HAYES                PHONE NO : 413 250 0779   
1349 MAIN ROAD                    SE DECISION MADE: 19-JAN-12
GRANVILLE MA 01034                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RS-4I MUSCLE STIMULATOR
RS MEDICAL                        510(k) NO: K112348(SPECIAL)
ATTN: PATRICK  COUGILL            PHONE NO : 866 849 6157   
14401 S.E. FIRST ST.              SE DECISION MADE: 19-JAN-12
VANCOUVER WA 98684                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, OPTIC DISC, MACULAR, GANGLION CELL AND ASIAN NORMATIVE DATABASES
CARL ZEISS MEDITEC INC            510(k) NO: K111157(TRADITIONAL)
ATTN: JUDITH A BRIMACOMBE         PHONE NO : 925 557 4616   
5160 HACIENDA DR.                 SE DECISION MADE: 19-JAN-12
DUBLIN CA 94568                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CABLE/ LEAD-WIRE (ECG, EKG, SPO2 AND INVASIVE BLOOD PRESSURE)
SHENZHEN MED-LINK ELECTRONICS TECH510(k) NO: K120010(TRADITIONAL)
ATTN: MAOLIN  YE                  PHONE NO : 867 556 158827
INDUSTRIAL HUA WANG RD DALANG LONGSE DECISION MADE: 19-JAN-12
SHENZHEN, GUANGDONG    CH 518109  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: NANOVIS SPINAL SYSTEM
NANOVIS, LLC                      510(k) NO: K113173(TRADITIONAL)
ATTN: KAREN E WARDEN PHD.         PHONE NO : 440 729 8457   
8202 SHERMAN RD.                  SE DECISION MADE: 19-JAN-12
CHESTERLAND OH 44026 2141         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KIMGUARD SMART-FOLD* STERILIZATION WRAP
KIMBERLY-CLARK CORP.              510(k) NO: K112300(SPECIAL)
ATTN: BRENDA  SHELKEY             PHONE NO : 678 352 6146   
1400 HOLCOMB BRIDGE RD. BLDG 300  SE DECISION MADE: 19-JAN-12
ROSWELL GA 30076 2199             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HISTOBRUSH
PURITAN MEDICAL PRODUCTS COMPANY L510(k) NO: K111681(TRADITIONAL)
ATTN: WILLIAM M YOUNG             PHONE NO : 207 876 3311   
31 SCHOOL ST.                     SE DECISION MADE: 19-JAN-12
GUILFORD ME 04443                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OASYS SPINAL SYSTEM
STRYKER SPINE                     510(k) NO: K111719(SPECIAL)
ATTN: SORAYA  KING                PHONE NO : 201 760 8296   
2 PEARL COURT                     SE DECISION MADE: 19-JAN-12
ALLENDALE NJ 07401                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DREAMGARD REM-SOFT, DREAMGARD REM-LITE, DREAMGARD REM-ULTRA, DREAMGARD REM-MAX
DREAMGARD, INC.                   510(k) NO: K112868(TRADITIONAL)
ATTN: SUZAN  ONEL                 PHONE NO : 202 778 9134   
1601 K STREET, NW                 SE DECISION MADE: 19-JAN-12
WASHINGTON DC 20006               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRULY AUTOMATIC ARM BLOOD PRESSURE MONITOR
TRULY INSTRUMENT CO., LTD.        510(k) NO: K113083(ABBREVIATED)
ATTN: MAX  WONG                   PHONE NO : 626 284 3033   
2620  CONCORD AVENUE SUITE 106    SE DECISION MADE: 19-JAN-12
ALHAMBRA CA 91803                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR
SIEMENS HEALTHCARE DIAGNOSTICS, IN510(k) NO: K110874(TRADITIONAL)
ATTN: NEIL  PARKER                PHONE NO : 914 524 2477   
511 BENEDICT AVE                  SE DECISION MADE: 20-JAN-12
TARRYTOWN NY 10591                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RELIANCE SPINAL SCREW SYSTEM
RELIANCE MEDICAL SYSTEMS, LLC     510(k) NO: K110896(SPECIAL)
ATTN: BRET M BERRY                PHONE NO : 801 388 0700   
545 SOUTH 500 WEST SUITE 100      SE DECISION MADE: 20-JAN-12
BOUNTIFUL UT 84010                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURGICAL TISSUE MANAGEMENT SYSTEM
OLYMPUS MEDICAL SYSTEMS CORP.     510(k) NO: K111202(TRADITIONAL)
ATTN: STACY A KLUESNER, M.S., RAC PHONE NO : 484 896 5405   
3500 CORPORATE PARKWAY            SE DECISION MADE: 20-JAN-12
CENTER VALLEY PA 18034 0610       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TORQTECH
J. MORITA USA, INC.               510(k) NO: K103697(TRADITIONAL)
ATTN: KEITH A BARRITT             PHONE NO : 202 783 5070   
1425 K STREET NW SUITE 1100       SE DECISION MADE: 20-JAN-12
WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CELLTRACKS AUTOPREP SYSTEM
VERIDEX, LLC                      510(k) NO: K110406(SPECIAL)
ATTN: JESSICA  SHELFFO            PHONE NO : 908 218 8173   
1001 US HIGHWAY 202 NORTH         SE DECISION MADE: 20-JAN-12
RARITAN NJ 08869 0606             510(k) STATEMENT

DEVICE: QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE
ANGIOTECH                         510(k) NO: K113800(SPECIAL)
ATTN: KIRSTEN  STOWELL            PHONE NO : 610 404 1000   
100 DENNIS DRIVE                  SE DECISION MADE: 20-JAN-12
READING PA 19606                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SAFE'SOUND LUER LOCK PASSIVE DEVLIVERY SYSTEM
REXAM CONSUMMER PLASTICS INC.D/B/A510(k) NO: K112936(ABBREVIATED)
ATTN: SANDRA  ANDERSON            PHONE NO : 847 325 3016   
800 CORP. GROVE DR.               SE DECISION MADE: 20-JAN-12
BUFFALO GROVE IL 60089            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISPOSABLE HEMOSTATIC Y-CONNECTORS
COEUR, INC.                       510(k) NO: K113132(TRADITIONAL)
ATTN: DEBRA F MANNING             PHONE NO : 615 547 7923   
100 PHYSICIANS WAY SUITE 200      SE DECISION MADE: 20-JAN-12
LEBANON TN 37090                  510(k) STATEMENT

DEVICE: REGENEROSS ALLOGRAFT PLUS MINERLIZED
BIOMET INTERPORE CROSS            510(k) NO: K113645(SPECIAL)
ATTN: KATHLEEN  OLIVARES          PHONE NO : 949 453 3200   
181 TECHNOLOGY DRIVE              SE DECISION MADE: 20-JAN-12
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMITH & NEPHEW HEALICOIL PK SUTURE ANCHOR
SMITH & NEPHEW, INC.              510(k) NO: K113294(TRADITIONAL)
ATTN: ELIZABETH  LAVELLE          PHONE NO : 508 261 3607   
150 MINUTEMAN RD.                 SE DECISION MADE: 20-JAN-12
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GPSCATH BALLON DILATATION CATHETER
HOTSPUR TECHNOLOGIES              510(k) NO: K113769(SPECIAL)
ATTN: ERIC  ANKERUD               PHONE NO : 978 302 9467   
880 MAUDE AVENUE SUITE A          SE DECISION MADE: 20-JAN-12
MOUNTAIN VIEW CA 94043            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LEXUS ANTERIOR CERVICAL PLATE SYSTEM
L&K BIOMED CO., LTD               510(k) NO: K113509(TRADITIONAL)
ATTN: HEE KYEONG  JOO             PHONE NO : 822 262 41471
#1104, ACE HIGH-END TOWER 3 CHA, 3SE DECISION MADE: 20-JAN-12
GEUMCHEON-GU, SEOUL    KS 153-803 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORS
NORTH AMERICAN SCIENCE ASSOC., INC510(k) NO: K113302(ABBREVIATED)
ATTN: JULIE  WHEELER              PHONE NO : 419 666 9455   
6750 WALES RD.                    SE DECISION MADE: 20-JAN-12
NORTHWOOD OH 43619                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TREPONRMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTORL MATERIALS
SIEMENS HEALTHCARE DIAGNOSTICS, IN510(k) NO: K112343(TRADITIONAL)
ATTN: KIRA  GORDON                PHONE NO : 914 524 2996   
511 BENEDICT AVE                  SE DECISION MADE: 20-JAN-12
TARRYTOWN NY 10591                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE..
RADIOMETER MEDICAL APS            510(k) NO: K112161(TRADITIONAL)
ATTN: JANA S HELLMANN             PHONE NO : 45 38 273827
AAKANDEVEJ 21                     SE DECISION MADE: 20-JAN-12
BRONSHOJ    DA DK-2700            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OPTICAGE INTERBODY FUSION DEVICE
INTERVENTIONAL SPINE, INC.        510(k) NO: K113527(TRADITIONAL)
ATTN: JANE  METCALF               PHONE NO : 949 525 1493   
13700 ALTON PKWY., SUITE 160      SE DECISION MADE: 20-JAN-12
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIAISON 25 OH VITAMIN D TOTAL ASSAY
DIASORIN, INC.                    510(k) NO: K112725(TRADITIONAL)
ATTN: JUDI  SMITH                 PHONE NO : 410 592 2060   
P.O. BOX 103                      SE DECISION MADE: 20-JAN-12
BALDWIN MD 21013                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPECTRA OPTIA APHERESIS SYSTEM
CARIDIANBCT, INC.                 510(k) NO: K113480(SPECIAL)
ATTN: TINA  O'BRIEN               PHONE NO : 303 239 2082   
10811 W. COLLINS AVE              SE DECISION MADE: 20-JAN-12
LAKEWOOD CO 80215                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICROFRANCE(R) WORMALD VASCULAR CLAMP
MEDTRONIC XOMED, INC.             510(k) NO: K112662(TRADITIONAL)
ATTN: MARSHA  SEETARAM            PHONE NO : 904 296 9600   
6743 SOUTHPOINT DR. NORTH         SE DECISION MADE: 20-JAN-12
JACKSONVILLE FL 32216             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DURABLUE STERILIZATION (AMSCO V-PRO) WRAP
CARDINAL HEALTH 200, LLC          510(k) NO: K112918(TRADITIONAL)
ATTN: LAVENIA  FORD               PHONE NO : 847 887 3323   
1430 WAUKEGAAN ROAD               SE DECISION MADE: 20-JAN-12
WAUKEGAN IL 60085                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: NEUROTECH RECOVERY
BIO-MEDICAL REASEARCH LTD.        510(k) NO: K112934(TRADITIONAL)
ATTN: ANNE-MARIE  KEENAN          PHONE NO : 353 917 74316
PARKMORE BUSINESS PARK WEST       SE DECISION MADE: 20-JAN-12
GALWAY    EI EI                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECE
BIOLITEC MEDICAL DEVICES, INC     510(k) NO: K113709(TRADITIONAL)
ATTN: HARRY  HAYES                PHONE NO : 413 250 0779   
1349 MAIN ROAD                    SE DECISION MADE: 20-JAN-12
GRANVILLE MA 01034                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3
RANDOX LABORATORIES LIMITED       510(k) NO: K110534(TRADITIONAL)
ATTN: PAULINE  ARMSTRONG          PHONE NO : 44 028 94422413
55 DIAMOND ROAD CRUMLIN           SE DECISION MADE: 23-JAN-12
CRUMLIN ANTRIM    UK BT29 4QY     510(k) STATEMENT

DEVICE: LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS
LIN-ZHI INTERNATIONAL, INC.       510(k) NO: K113661(TRADITIONAL)
ATTN: BERNICE  LIN                PHONE NO : 408 732 3856   
670 Almanor Ave                   SE DECISION MADE: 23-JAN-12
SUNNYVALE CA 94085                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNDE-LOCK SYNDESMOSIS REPAIR KIT
TARSUS MEDICAL INC.               510(k) NO: K111971(TRADITIONAL)
ATTN: NICHOLAS  MOURLAS           PHONE NO : 650 237 0070   
465 FAIRCHILD DRIVE SUITE 230     SE DECISION MADE: 23-JAN-12
MOUNTAIN VIEW CA 94043            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONCENPIECE,HIGH-SPEED HANDPIECE SERIES
DENTALEZ, INC.                    510(k) NO: K113301(TRADITIONAL)
ATTN: JIM  WATKINS                PHONE NO : 717 291 1161   
1816 COLONIAL VILLAGE LN.         SE DECISION MADE: 23-JAN-12
LANCASTER PA 17601                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OMWGW LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES
OMEGA LABORATORIES, INC.          510(k) NO: K112808(TRADITIONAL)
ATTN: ROBERT J BARD               PHONE NO : 248 573 5040   
400 NORTH CLEVELAND               SE DECISION MADE: 23-JAN-12
MOGADORE OH 44260                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZIMMER CONTOUR PROVISIONAL COPING
ZIMMER DENTAL INC.                510(k) NO: K113092(TRADITIONAL)
ATTN: JEREMY  MARKOVICH           PHONE NO : 760 929 4300   
1900 ASTON AVE.                   SE DECISION MADE: 23-JAN-12
CARLSBAD CA 92008 7308            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT
PRIME DENTAL MANUFACTURING, INC.  510(k) NO: K112574(TRADITIONAL)
ATTN: JAVIER  ALVAREZ             PHONE NO : 773 283 2914   
4555 WEST ADDISON STREET          SE DECISION MADE: 23-JAN-12
CHICAGO IL 60641                  510(k) STATEMENT

DEVICE: PCXX VARNICH
ROSS HEALTHCARE INC.              510(k) NO: K113146(ABBREVIATED)
ATTN: MARC N ROSS                 PHONE NO : 604 521 6626   
1750 GRANT AVE                    SE DECISION MADE: 23-JAN-12
BLAINE WA 98230                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COBAS 4800 CT / NG TEST
ROCHE MOLECULAR SYSTEMS, INC.     510(k) NO: K110923(TRADITIONAL)
ATTN: JAMES  BONDS                PHONE NO : 925 730 8729   
4300 HACIENDA DRIVE               SE DECISION MADE: 24-JAN-12
PLEASANTON CA 94588 2722          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MTF NEW BONE VOILD FILLER
MUSCULOSKELETAL TRANSPLANT FOUNDAT510(k) NO: K113167(TRADITIONAL)
ATTN: NANCY  JOY                  PHONE NO : 732 661 2381   
125 MAY STREET                    SE DECISION MADE: 24-JAN-12
EDISON NJ 08837                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERITEC CONTAINERS SYSTEM & MEDITRAY PRODUCTS
CASE MEDICAL, INC.                510(k) NO: K112904(TRADITIONAL)
ATTN: TANIA  LUPU                 PHONE NO : 201 313 1999   
19 Empire Blvd                    SE DECISION MADE: 24-JAN-12
S Hackensack NJ 07606             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROL
AALTO SCIENTIFIC LTD.             510(k) NO: K112705(TRADITIONAL)
ATTN: DESSI  LYAKOV               PHONE NO : 760 431 6942   
1959 KELLOGG AVE.                 SE DECISION MADE: 24-JAN-12
CARLSBAD CA 92008                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEGABEAM ENDO-ENT PROBE
BIOLITEC MEDICAL DEVICES, INC     510(k) NO: K113858(TRADITIONAL)
ATTN: HARRY  HAYES                PHONE NO : 413 250 0779   
1349 MAIN ROAD                    SE DECISION MADE: 24-JAN-12
GRANVILLE MA 01034                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IVAS BALLOON CATHETER
STRYKER CORPORATION               510(k) NO: K113154(TRADITIONAL)
ATTN: MEGHAN  ARREAZA             PHONE NO : 269 389 5205   
4100 E. MILHAM AVE.               SE DECISION MADE: 24-JAN-12
KALAMAZOO MI 49001                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONTIPLEX FX
B. BRAUN MEDICAL, INC.            510(k) NO: K113059(TRADITIONAL)
ATTN: LISA  GIAQUINTO             PHONE NO : 610 596 0500   
901 MARCON BLVD.                  SE DECISION MADE: 24-JAN-12
ALLENTOWN PA 18109 9341           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION
BAUSCH & LOMB, INC.               510(k) NO: K111877(TRADITIONAL)
ATTN: HEATHER  MICHAELS           PHONE NO : 585 338 8493   
1400 NORTH GOODMAN ST.            SE DECISION MADE: 24-JAN-12
ROCHESTER NY 14609 3547           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GENESIS TOUCH SYSTEM
HONEYWELL HOMMED, LLC             510(k) NO: K112858(TRADITIONAL)
ATTN: CLAUDIA  JACKSON            PHONE NO : 262 252 5838   
3400 INTERTECH DR. SUITE 200      SE DECISION MADE: 24-JAN-12
BROOKFIELD WI 53045               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SONIXTABLET ULTRASOUND SCANNER
ULTRASONIX MEDICAL CORPORATION    510(k) NO: K113663(TRADITIONAL)
ATTN: CHAS  YU                    PHONE NO : 604 279 8550
130-4311 VIKING WAY               SE DECISION MADE: 25-JAN-12
RICHMOND, BRITISH COLUMBIA    CA V510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: DP-5 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM DP-7 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
SHENZHEN MINDRAY BIO-MEIDCAL ELECT510(k) NO: K113632(SPECIAL)
ATTN: SUSAN D GOLDSTEIN           PHONE NO : 949 706 7456   
55 NORTHERN BLVD. SUITE 200       SE DECISION MADE: 25-JAN-12
NEW YORK NY 11021                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PANORAD, PANORAD SL
IMIX ADR FINLAND OY               510(k) NO: K113855(SPECIAL)
ATTN: DANIEL  KAMM                PHONE NO : 239 234 1735   
8870 RAVELLO CT                   SE DECISION MADE: 25-JAN-12
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUN 125C IONIZATION CHAMBER
SUN NUCLEAR CORP.                 510(k) NO: K112981(TRADITIONAL)
ATTN: NOEL  DOWNEY                PHONE NO : 321 259 6862   
425 PINEDA COURT                  SE DECISION MADE: 25-JAN-12
MELBOURNE FL 32940                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE
MEDTRONIC INC.                    510(k) NO: K113845(SPECIAL)
ATTN: KEVIN T LAM                 PHONE NO : 763 526 2360   
7611 NORTHLAND DRIVE              SE DECISION MADE: 25-JAN-12
MINNEAPOLIS MN 55428              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XENON(TM) PEDICLE SCREW SYSTEM
ALPHATEC SPINE, INC.              510(k) NO: K111634(TRADITIONAL)
ATTN: CHERYL  ALLEN               PHONE NO : 760 494 6770   
5818 EL CAMINO REAL               SE DECISION MADE: 25-JAN-12
CARLSBAD CA 92008                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARDIFF ANTERIOR CERVICAL PLATE SYSTEM
SEASPINE, INC.                    510(k) NO: K112206(SPECIAL)
ATTN: DAN  MILLER                 PHONE NO : 760 727 8399   
2302 LA MIRADA DR.                SE DECISION MADE: 25-JAN-12
VISTA CA 92081 7862               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THERATRODE
PHOENIX MEDICAL DEVICES, LLP      510(k) NO: K112312(TRADITIONAL)
ATTN: JIM  KLETT                  PHONE NO : 949 724 1141   
2458 ALTON PARKWAY                SE DECISION MADE: 25-JAN-12
IRVINE CA 92606                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SWISSMEDA DENTAL PLANNING SYSTEM
SWISSMEDA AG                      510(k) NO: K112251(TRADITIONAL)
ATTN: JORG  DANZBERG              PHONE NO : 414 381 82515
TECHNOPARKSTRASSE 1               SE DECISION MADE: 25-JAN-12
ZURICH    SZ 8005                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD
TORNIER, INC.                     510(k) NO: K111337(TRADITIONAL)
ATTN: HOWARD L SCHRAYER           PHONE NO : 609 924 9510   
7701 FRANCE AVE SOUTH SUITE 600   SE DECISION MADE: 25-JAN-12
EDINA MN 55435                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOCHOICE WATER BOTTLE CAP SYSTEM
ENDOCHOICE, INC.                  510(k) NO: K112576(TRADITIONAL)
ATTN: THERON  GOBER               PHONE NO : 678 534 6021   
11810 WILLS ROAD SUITE 100        SE DECISION MADE: 25-JAN-12
ALPHARETTA GA 30009               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AQUILION PRIME
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K110066(TRADITIONAL)
ATTN: PAUL  BIGGINS               PHONE NO : 714 669 7808   
2441 MICHELLE DR. P.O. BOX 2068   SE DECISION MADE: 26-JAN-12
TUSTIN CA 92781 2068              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
SIEM AEMPEMED CORP., LTD          510(k) NO: K111134(ABBREVIATED)
ATTN: WILLIAM E HARRIS, III       PHONE NO : 727 787 7250   
13900 49TH STREET                 SE DECISION MADE: 26-JAN-12
CLEARWATER FL 33762               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLICKFINE AUTOPROTECT PEN NEEDLE
YPSOMED AG                        510(k) NO: K110312(TRADITIONAL)
ATTN: ANDRE  SAUTER               PHONE NO : 004 134 4243967
BRUNNMATTSTRASSE 6                SE DECISION MADE: 26-JAN-12
BURGDORF    SZ CH-3401            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANAXBLEND MODEL 20XXX (SEVERAL), ANAXGUM MODEL 25XXX (U), MOCK-UP DIRECT MODEL 240XXX (U), MOCK-UP DIRECT FLOW MODEL 24A
ANAXDENT GMBH                     510(k) NO: K112044(ABBREVIATED)
ATTN: JOHN  BALISTRERI            PHONE NO : 858 361 9286   
14500 FIM 470                     SE DECISION MADE: 26-JAN-12
TARPLEY TX 78883                  510(k) STATEMENT

DEVICE: FORE-SIGHT ABSOLUTE TISSUE OXIMETER
CAS MEDICAL SYSTEMS, INC.         510(k) NO: K112820(TRADITIONAL)
ATTN: RON  JEFFREY                PHONE NO : 203 488 6056   
44 EAST INDUSTRIAL RD.            SE DECISION MADE: 26-JAN-12
BRANFORD CT 06405                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPINEOLOGY PEEK BULLET LUMBAR INTERBODY FUSION DEVICE
SPINEOLOGY, INC.                  510(k) NO: K113030(SPECIAL)
ATTN: BRYAN  BECKER               PHONE NO : 651 256 8500   
7800 3RD ST N., SUITE 600         SE DECISION MADE: 26-JAN-12
ST. PAUL MN 55128                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PILOT TUBE REPAIR KIT
INSTRUMENTATION INDUSTRIES, INC.  510(k) NO: K113644(SPECIAL)
ATTN: DORIS F WALTER              PHONE NO : 412 854 1133   
2990 INDUSTRIAL BLVD.             SE DECISION MADE: 26-JAN-12
BETHEL PARK PA 15102              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GAL-1A BLOOD GLUCOSE MONITORING SYSTEM
APEX BIOTECHNOLOGY CORP.          510(k) NO: K113208(SPECIAL)
ATTN: HSUE-MEI  LEE               PHONE NO : 886 356 41952
NO. 7, LI-HSIN ROAD V, HSINCHU SCISE DECISION MADE: 26-JAN-12
HSINCHU    TW 30078               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PIONEER RELEASE LAMINOPLASTY PLATING SYSTEM
PIONEER SURGICAL TECHNOLOGY, INC  510(k) NO: K113218(TRADITIONAL)
ATTN: SARAH  MCLNTYRE             PHONE NO : 906 225 5861   
375 RIVER PARK CIRCLE             SE DECISION MADE: 26-JAN-12
Marquette MI 49855                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LOGICSCAN 64 LOGICSCAN 128
TELEMED                           510(k) NO: K113184(TRADITIONAL)
ATTN: YURY  SOKOLOV               PHONE NO : 370 521 06272
DARIARUS IR GIRENO STREET 42      SE DECISION MADE: 26-JAN-12
VILNIUS    LH LT-02189            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SIMPLELINE II ABUTMENT SYSTEM
DENTIUM CO., LTD.                 510(k) NO: K112045(ABBREVIATED)
ATTN: JONGHYUN  CHOI              PHONE NO : 82 31 2072200
27-5 LEUI-DONG, YEONGTONG-GU      SE DECISION MADE: 26-JAN-12
SUWON-SI, GYEONGGI-DO    KS 442-27510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CYNOSURE CELLULAZE LASER
CYNOSURE, INC.                    510(k) NO: K102541(TRADITIONAL)
ATTN: GEORGE  CHO                 PHONE NO : 978 256 4200   
5 CARLISLE ROAD                   SE DECISION MADE: 26-JAN-12
WESTFORD MA 01886                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM
STRYKER CORP.                     510(k) NO: K111786(TRADITIONAL)
ATTN: ESTELA  CELI                PHONE NO : 201 831 6461   
325 CORPORATE DRIVE               SE DECISION MADE: 26-JAN-12
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LOGIC LAPAROSCOPIC INSTRUMENT SYSTEM
SURGICAL INNOVATIONS PLC          510(k) NO: K111986(TRADITIONAL)
ATTN: PAUL  BIRTLES               PHONE NO : 440 113 2307597
CLAYTON WOOD HOUSE, 6 CLAYTON WOODSE DECISION MADE: 26-JAN-12
LEEDS, WEST YORKSHIRE    UK LS16 6510(k) STATEMENT

DEVICE: BICARB MIXING AND DISTRIBUTION SYSTEM
ISOPURE CORP.                     510(k) NO: K112427(SPECIAL)
ATTN: KEVIN C GILLESPIE           PHONE NO : 502 722 1000   
141 CITIZENS BLVD.                SE DECISION MADE: 26-JAN-12
SIMPSONVILLE KY 40067 6548        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GIZA(R) VERTEBRAL BODY REPLACEMENT
EDEN SPINE, LLC                   510(k) NO: K112429(TRADITIONAL)
ATTN: RICH  JANSEN                PHONE NO : 612 281 5505   
13540 GUILD AVE                   SE DECISION MADE: 26-JAN-12
APPLE VALLEY MN 55124             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CALG-STR EXERCISE ECG ANALYSIS ALGORITHM
PHILIPS HEALTHCARE                510(k) NO: K112959(TRADITIONAL)
ATTN: GRETEL  LUMLEY              PHONE NO : 805 214 5101   
1525 RANCHO CONEJO BLVD SUITE 100 SE DECISION MADE: 26-JAN-12
THOUSAND OAKS CA 91320            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GAP ENDO-EXO MEDULLARY SYSTEM
PEGA MEDICAL INC.                 510(k) NO: K111232(TRADITIONAL)
ATTN: ARIEL R DUJOVNE             PHONE NO : 450 688 5144
1111 AUTOROUTE CHOMEDEY           SE DECISION MADE: 26-JAN-12
LAVAL    CA H7W 5J8               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INFX-8000V WITH
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K120073(SPECIAL)
ATTN: PAUL  BIGGINES              PHONE NO : 714 669 7808   
2441 MICHELLE DRIVE               SE DECISION MADE: 26-JAN-12
TUSTIN CA 92781                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AM-6000 ANESTHESIA MACHINE
ADVANCED INSTRUMENTATIONS, INC.   510(k) NO: K120075(TRADITIONAL)
ATTN: JORGE  MILLAN               PHONE NO : 305 925 1260   
601 WEST 20 ST                    SE DECISION MADE: 26-JAN-12
HIALEAH FL 33010                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RISE SPACER
GLOBAL MEDICAL, INC.              510(k) NO: K113447(SPECIAL)
ATTN: KELLY J BAKER               PHONE NO : 610 930 1800   
2560 GENERAL ARMISTEAD AVE.       SE DECISION MADE: 26-JAN-12
AUDUBON PA 19403                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GMK RESUFACING PATELLA SIZE 4
MEDACTA INTERNATIONAL             510(k) NO: K113571(SPECIAL)
ATTN: ADAM  GROSS                 PHONE NO : 805 437 7085   
4725 CALLE QUETZAL, UNIT B        SE DECISION MADE: 27-JAN-12
CAMARILLO CA 93012                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SANTORINI SPINAL SYSTEM
K2M, INC.                         510(k) NO: K111294(TRADITIONAL)
ATTN: NANCY  GIEZEN               PHONE NO : 703 777 3155   
751 MILLER DR.,SE                 SE DECISION MADE: 27-JAN-12
LEESBURG VA 20175                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICRODOT & MICRODOT XTRA
CAMBRIDGE SENSORS LIMITED         510(k) NO: K102383(TRADITIONAL)
ATTN: BERNADETTE  YON-HIN         PHONE NO : 44 148 0482920
UNITS 9&10 CARDINAL PARK GODMANCHESE DECISION MADE: 27-JAN-12
HUNTINGDON, CAMBRIDGESHIRE    UK P510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VALIDATE VIT D CALIBRATION VERIFICATION/ LINEARITY TEST KIT
MAINE STANDARDS CO.               510(k) NO: K113524(TRADITIONAL)
ATTN: HOLLY A CRESSMAN            PHONE NO : 207 892 1300   
765 ROOSEVELT TRAIL               SE DECISION MADE: 27-JAN-12
WINDHAM ME 04062 5365             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEUMOVENT GRAPHNET
TECME S.A.                        510(k) NO: K111595(TRADITIONAL)
ATTN: RAY  KELLY                  PHONE NO : 603 809 7668   
79 BROOKLINE ROAD                 SE DECISION MADE: 27-JAN-12
MASON NH 03048                    510(k) STATEMENT

DEVICE: BOVIE J-PLASMA HANDPIECE WITH RETRACTABLE CUTTING BLADE
BOVIE MEDICAL CORPORATION         510(k) NO: K112233(TRADITIONAL)
ATTN: RICHARD A KOZLOFF           PHONE NO : 727 384 2323   
5115 Ulmerton Road                SE DECISION MADE: 27-JAN-12
Clearwater FL 33760 0000          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOCKET GRAFT
STEINER LABORATORIES              510(k) NO: K113049(TRADITIONAL)
ATTN: GREGORY G STEINER           PHONE NO : 808 689 1710   
590 FARRINGTON HWY. #524 SUITE 132SE DECISION MADE: 27-JAN-12
KAPOLEI HI 96707                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FINGERTIP PULSE OXIMETER
GUANGDONG BIOLIGHT MEDITECH CO., L510(k) NO: K112804(SPECIAL)
ATTN: DIANA  HONG                 PHONE NO : 86 212 285850
P.O. BOX 237-023                  SE DECISION MADE: 27-JAN-12
SHANGHAI    CH 200237             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODEL HBP-1300
OMRON HEALTHCARE, INC.            510(k) NO: K113185(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DRIVE              SE DECISION MADE: 27-JAN-12
BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CATHETER CONNECTIONS' DUALCAP SOLO
CATHETER CONNECTIONS, INC.        510(k) NO: K113842(SPECIAL)
ATTN: DONALD D SOLOMON            PHONE NO : 801 209 1269   
615 Arapeen Dr Ste 302A           SE DECISION MADE: 27-JAN-12
Salt Lake City UT 84108           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICROLIFE DUAL MODE THERMOMETER,MODEL IFR1MJ1
MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K113141(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK      PHONE NO : 417 172 77000
55 NORTHERN BOULEVARD SUITE 200   SE DECISION MADE: 27-JAN-12
GREAT NECK NY 10021               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NNC GOLD ABUTMENT FOR BRIDGES
STRAUMANN USA                     510(k) NO: K113606(SPECIAL)
ATTN: ELAINE  ALAN                PHONE NO : 978 747 2513   
60 MINUTEMAN ROAD                 SE DECISION MADE: 27-JAN-12
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELECTRO-CAP SYSTEM
ELECTRO-CAP INTL., INC.           510(k) NO: K112319(TRADITIONAL)
ATTN: AMY B SWALLOWS              PHONE NO : 937 456 6099   
1011 WEST LEXINGTON RD.           SE DECISION MADE: 27-JAN-12
EATON OH 45320                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REST ASSURED READY TO WEAR NITE PROTECTOR
RANIR LLC                         510(k) NO: K112879(SPECIAL)
ATTN: GERARD J PRUD'HOMME         PHONE NO : 202 637 5735   
555 THIRTEENTH STREET, NW         SE DECISION MADE: 27-JAN-12
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VOLCANO S5I INTRAVASCULAR ULTRACOUND IMAGING AND PRESSURE SYSTEM
VOLCANO CORPORATION               510(k) NO: K113486(SPECIAL)
ATTN: JWALA  JAWHARKAR            PHONE NO : 916 281 2925   
2870 KILGORE RD.                  SE DECISION MADE: 27-JAN-12
RANCHO CORDOVA CA 95670           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPOTLIGHT ACCESS SYSTEM
JOHNSON & JOHNSON                 510(k) NO: K113273(TRADITIONAL)
ATTN: LAURA  BLEYENDAAL           PHONE NO : 508 828 3267   
325 PARAMOUNT DRIVE               SE DECISION MADE: 27-JAN-12
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NCB STRAIGHT NARROW SHAFT PLATES
ZIMMER GMBH                       510(k) NO: K113718(TRADITIONAL)
ATTN: STEPHEN H MCKELVEY          PHONE NO : 574 372 4944   
PO BOX 708                        SE DECISION MADE: 27-JAN-12
WARSAW IN 46581                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMS
BLUE SKY BIO, LLC                 510(k) NO: K112875(TRADITIONAL)
ATTN: MICHELE  VOVOLKA            PHONE NO : 847 548 8499   
888 E BELVIDERE RD. SUITE 212     SE DECISION MADE: 27-JAN-12
GRAYSLAKE IL 60030                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PATHASSIST LIGHT SEEKER
ENTELLUS MEDICAL, INC.            510(k) NO: K113522(SPECIAL)
ATTN: GARRETT P AHLBORG           PHONE NO : 763 463 7074   
6705 WEDGWOOD COURT NORTH         SE DECISION MADE: 27-JAN-12
MAPLE GROVE MN 55311              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT PROCEDURE KIT
ANGIODYNAMICS, INC.               510(k) NO: K112600(TRADITIONAL)
ATTN: TERI  JUCKETT               PHONE NO : 518 798 1215   
603 QUEENSBURY AVE.               SE DECISION MADE: 30-JAN-12
QUEENSBURY NY 12804               510(k) STATEMENT

DEVICE: GLUCOSE METER-CHECK SOLUTION FOR INFOPIA
BIONOSTICS, INC.                  510(k) NO: K113764(TRADITIONAL)
ATTN: RANDY  BYRD                 PHONE NO : 978 772 7070   
7 JACKSON RD.                     SE DECISION MADE: 30-JAN-12
Devens MA 01434                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMART READ EZTEST STEAM
MESA LABORATORIES, INC.           510(k) NO: K112018(TRADITIONAL)
ATTN: WENDY  ROYALTY              PHONE NO : 406 585 9535   
10 EVERGREEN DRIVE                SE DECISION MADE: 30-JAN-12
BOZEMAN MT 59715                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE
AM USA                            510(k) NO: K113555(SPECIAL)
ATTN: KAREN  THOMISON             PHONE NO : 615 833 2633   
5209 LINDBAR DRIVE SUITE 630      SE DECISION MADE: 30-JAN-12
NASHVILLE TN 37167                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DELL ULTRASHARP U3011 W/QUBYX PERFECTLUM BUNDLE
QUBYX LIMITED                     510(k) NO: K111385(TRADITIONAL)
ATTN: MARC  LEPPLA                PHONE NO : 334 970 32300
80, RUE MARECHAL JOFFRE           SE DECISION MADE: 30-JAN-12
NICE    FR 06000                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALDAHOL V HIGH LEVEL DISINFECTANT
MICROCHEM LABORATORIES, INC.      510(k) NO: K113015(TRADITIONAL)
ATTN: NORMAN  MINER               PHONE NO : 817 283 9100   
1107-C SOUTH AIRPORT CIRCLE       SE DECISION MADE: 30-JAN-12
EULESS TX 76040                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LRT ATTACHMENT
BCF CERTIFICATION INC.            510(k) NO: K112333(TRADITIONAL)
ATTN: LOUIS-PAUL  MARIN           PHONE NO : 514 397 5546
1100 RENE-LEVESQUE BLVD. WEST, 25TSE DECISION MADE: 30-JAN-12
MONTREAL    CA H4L 2L8            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAAS A-VALVE
PIE MEDICAL IMAGING B.V.          510(k) NO: K113076(TRADITIONAL)
ATTN: FLORIE  DANIELS             PHONE NO : 314 332 81328
BECANUSSTRAAT 13 D                SE DECISION MADE: 30-JAN-12
MAASTRICHT    NL 6216 BX          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOGEL (R) INDICATOR (R) UNDERGLOVE
MOLNLYCKE HEALTHCARE, US LLC      510(k) NO: K111413(SPECIAL)
ATTN: ANGELA L BUNN               PHONE NO : 678 250 7930   
5550 PEACHTREE PARKWAY SUITE 500  SE DECISION MADE: 30-JAN-12
NORCROSS GA 30092                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CHISON DIGITAL ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, TRANSVAGINAL MICRO-CONVEX PROBE, TRANSRECTAL LINEAR PROBE
LEIKER REGULATORY & QUALITY CONSUL510(k) NO: K112539(TRADITIONAL)
ATTN: BOB  LEIKER                 PHONE NO : 925 556 1302   
7263 CRONIN CIRCLE                SE DECISION MADE: 30-JAN-12
DUBLIN CA 94568                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLARITY OBP SYSTEM
ELEKTA LTD.                       510(k) NO: K111332(TRADITIONAL)
ATTN: GEORGE  PAPAGIANNIS         PHONE NO : 514 985 2442
2050 BLEURY, SUITE 200            SE DECISION MADE: 30-JAN-12
MONTREAL    CA H3A 2J5            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAXLOCK EXTREME SYSTEM
ORTHOHELIX SURGICAL DESIGNS, INC. 510(k) NO: K113048(TRADITIONAL)
ATTN: DEREK  LEWIS                PHONE NO : 330 869 9562   
1065 Medina Rd. SUITE 500         SE DECISION MADE: 30-JAN-12
Medina OH 44256                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MCKESSON HORIZON CARDIOLOGY
MCKESSON ISRAEL LTD.              510(k) NO: K112720(TRADITIONAL)
ATTN: TOMER  LEVY                 PHONE NO : 972 376 98000
HANECHOSHET 4                     SE DECISION MADE: 30-JAN-12
TEL AVIV    IS 69710              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UNIVERSAL DIGITAL INTERFACE WIRELESS - UDI 1417W
MERIDIAN MEDICAL SYSTEMS, LLC     510(k) NO: K111305(TRADITIONAL)
ATTN: ARIEL  MARCIANO             PHONE NO : 407 719 9853   
325 HARRIS DRIVE                  SE DECISION MADE: 31-JAN-12
AURORA OH 44202                   510(k) STATEMENT

DEVICE: TRANSTEK BLOOD PRESSURE MONITOR
ZHONGSHAN TRANSTEK ELECTRONICS CO.510(k) NO: K120058(SPECIAL)
ATTN: LEO  WANG                   PHONE NO : 086 26 86083300
NO. 1 FANGHUA STREET HI-TECH DISTRSE DECISION MADE: 31-JAN-12
CHENGDU    CH 610041              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACTIVECARE DVT ACTIVECARE+SFT
MEDICAL COMPESSION SYSTMES (DBH) L510(k) NO: K113525(TRADITIONAL)
ATTN: JONATHAN S KAHAN            PHONE NO : 202 637 5794   
555 13TH STREET, NW               SE DECISION MADE: 31-JAN-12
WASHINGTON, DC DC 20004           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLAW II POLYAXIAL COMPRESSION SYSTEM AND ORTHOLOC 3DSI LOCKING SCREWS
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K113014(TRADITIONAL)
ATTN: PEGGY S RIVERS              PHONE NO : 901 867 4759   
5677 AIRLINE RD.                  SE DECISION MADE: 31-JAN-12
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TWINFIX ULTRA TI, TWINFIX ULTRA PK, TWINFIX ULTRA HA SUTURE ANCHORS
SMITH & NEPHEW, INC.              510(k) NO: K112526(TRADITIONAL)
ATTN: MELISSA  EGAN               PHONE NO : 508 261 3645   
150 MINUTEMAN RD.                 SE DECISION MADE: 31-JAN-12
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUDIT MICROCV T-UPTAKE LINEARITY
AALTO SCIENTIFIC LTD.             510(k) NO: K112143(TRADITIONAL)
ATTN: DESSI  LYAKOV               PHONE NO : 760 431 6942   
1959 KELLOGG AVE.                 SE DECISION MADE: 31-JAN-12
CARLSBAD CA 92008                 510(k) SUMMARY AVAILABLE FROM FDA


                                                 TOTAL 510(k)s THIS PERIOD   228                                     
                                                 TOTAL WITH SUMMARIES        210                                     
                                                 TOTAL WITH STATEMENTS        18
                                      

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