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U.S. Department of Health and Human Services

Medical Devices

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December 2011 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD December 2011


DEVICE: NEWPORT HT70 VENTILATOR
NEWPORT MEDICAL INSTRUMENTS, INC. 510(k) NO: K111146(TRADITIONAL)
ATTN: TOM  COLONNA                PHONE NO : 714 427 5811   
1620 SUNFLOWER AVE.               SE DECISION MADE: 01-DEC-11
COSTA MESA CA 92626               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVES (ORIGINAL BLUE, COBALT BLUE)
YTY INDUSTRY (MANJUNG) SDN. BHD.  510(k) NO: K111248(TRADITIONAL)
ATTN: JANNA  TUCKER               PHONE NO : 775 342 2612   
198 AVENUE DE LA D'EMERALD        SE DECISION MADE: 01-DEC-11
SPARKS NV 89434 9550              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ATLANTIS ABUTMENT IN ZIRCONIA FOR ASTRA TECH OSSEOSPEED PLUS IMPLANT
ASTRA TECH, INC.                  510(k) NO: K112138(TRADITIONAL)
ATTN: BETSY A BROWN               PHONE NO : 847 560 4406   
8944 TAMAROA TERR.                SE DECISION MADE: 01-DEC-11
SKOKIE IL 60076                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SNAP WOUND CARE SYSTEM
SPIRACUR, INC.                    510(k) NO: K113032(TRADITIONAL)
ATTN: SARAH  CANIO                PHONE NO : 408 400 0856   
755 N. MATHILDA AVENUE            SE DECISION MADE: 01-DEC-11
SUNNYVALE CA 94085                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMSCO V-PRO
STERIS CORP.                      510(k) NO: K112813(SPECIAL)
ATTN: ROBERT  SULLIVAN            PHONE NO : 440 354 2600   
5960 HEISLEY RD.                  SE DECISION MADE: 01-DEC-11
MENTOR OH 44060                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES
MISONIX, INC.                     510(k) NO: K112782(TRADITIONAL)
ATTN: RONALD R MANNA              PHONE NO : 631 694 9555   
1938 NEW HIGHWAY                  SE DECISION MADE: 01-DEC-11
FARMINGDALE NY 11735              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JENSEN ZIRCONIA
JENSEN INDUSTRIES, INC.           510(k) NO: K112806(ABBREVIATED)
ATTN: GARY  PHELPS                PHONE NO : 203 239 2090   
50 STILLMAN RD.                   SE DECISION MADE: 01-DEC-11
NORTH HAVEN CT 06473              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCULIF TL-PEEK IBF CAGE
COALIGN INNOVATIONS, INC.         510(k) NO: K112095(TRADITIONAL)
ATTN: JUSTIN  EGGLETON            PHONE NO : 202 552 5800   
1331 H STREET NW 12TH FLOOR       SE DECISION MADE: 01-DEC-11
WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ASAHI CHIKAI 10 NEUROVASCULAR GUIDE WIRE
ASAHI INTECC CO., LTD.            510(k) NO: K112979(TRADITIONAL)
ATTN: YOSHI  TERAI                PHONE NO : 949 756 8252   
2500 RED HILL AVE, SUITE 210      SE DECISION MADE: 01-DEC-11
SANTA ANA CA 92705                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LATERAL BUTTON
T.A.G. MEDICAL PRODUCTS CORPORATIO510(k) NO: K112296(TRADITIONAL)
ATTN: GEORGE J HATTUB             PHONE NO : 508 479 6116   
291 HILLSIDE AVE.                 SE DECISION MADE: 01-DEC-11
SOMERSET MA 02726                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS
GRI MEDICAL & ELECTRONIC TECHNOLOG510(k) NO: K111458(TRADITIONAL)
ATTN: PENNY  NORTHCUTT            PHONE NO : 678 428 6978   
717 LAKEGLEN DRIVE                SE DECISION MADE: 01-DEC-11
SUWANEE GA 30024                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321
TOSOH BIOSCIENCE, INC.            510(k) NO: K111335(TRADITIONAL)
ATTN: JUDITH K OGDEN              PHONE NO : 650 636 8112   
6000 SHORELINE COURT SUITE 101    SE DECISION MADE: 01-DEC-11
SOUTH SAN FRANCISCO CA 94080      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GUIDELINER V2 CATHETER
VASCULAR SOLUTIONS, INC.          510(k) NO: K112082(SPECIAL)
ATTN: MATT  NIENSTEDT             PHONE NO : 763 656 4300   
6464 SYCAMORE COURT               SE DECISION MADE: 01-DEC-11
MINNEAPOLIS MN 55369              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRESTIGE 24I; BIOLIS 24I; MGC 240
TOKYO BOEKI MEDISYS INC.          510(k) NO: K103531(TRADITIONAL)
ATTN: JAMES M CLINTON             PHONE NO : 919 247 0479   
5105 FAIROAKS ROAD                SE DECISION MADE: 01-DEC-11
DURHAM NC 27712                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HYDROCOIL(R) EMBOLIC SYSTEM (HES)
MICROVENTION, INC.                510(k) NO: K112181(SPECIAL)
ATTN: VIN  CUTARELLI              PHONE NO : 714 247 8181   
1311 VALENCIA AVE                 SE DECISION MADE: 01-DEC-11
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RENAISSANCE SYSTEM
MAZOR ROBOTICS LTD                510(k) NO: K113228(SPECIAL)
ATTN: AHAVA  STEIN                PHONE NO : 972 976 70002
20 HATA'AS ST.                    SE DECISION MADE: 01-DEC-11
KFAR SABA    IS 44425             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVEL
RANDOX LABORATORIES, LTD.         510(k) NO: K112337(TRADITIONAL)
ATTN: PAULINE  ARMSTRONG          PHONE NO : 440 289 4422413
55 DIAMOND RD.                    SE DECISION MADE: 01-DEC-11
CRUMLIN, COUNTY ANTRIM    UK BT29 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NARAL CC
RESMED SAS                        510(k) NO: K113201(ABBREVIATED)
ATTN: DAVID  D'CRUZ               PHONE NO : 858 836 5984   
9001 SPECTRUM CENTER BLVD.        SE DECISION MADE: 01-DEC-11
SAN DIEGO CA 92123                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GENUINE FIRST AID CPR MASK
GENUINE FIRST AID LLC             510(k) NO: K112126(TRADITIONAL)
ATTN: GARY  LEHNUS                PHONE NO : 570 620 0198   
150 CHERRY LANE RD.               SE DECISION MADE: 01-DEC-11
EAST STROUDSBURG PA 18301         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADVANCED TRAUMA DRESSING (ATD)
NANOSYS, INC.                     510(k) NO: K101257(TRADITIONAL)
ATTN: HUGH  DANIELS               PHONE NO : 650 331 2108   
2625 HANOVER STREET               SE DECISION MADE: 01-DEC-11
PALO ALTO CA 94304                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE
BEBE TOYS MANUFACTORY LTD.        510(k) NO: K110615(TRADITIONAL)
ATTN: PAUL A WARE                 PHONE NO : 781 341 2488   
34 MCNAMARA STREET                SE DECISION MADE: 02-DEC-11
STOUGHTON MA 02072                510(k) STATEMENT

DEVICE: ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500
DNA GENOTEK INC                   510(k) NO: K110701(TRADITIONAL)
ATTN: CHANTAL  HEMENS-DAVIS       PHONE NO : 613 723 5757
2 BEAVERBROOK ROAD                SE DECISION MADE: 02-DEC-11
OTTAWA  ONTARIO    CA K2K 1L1     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ESENSOR WARFARIN SENSITIVITY SALIVA TEST
GENMARK DIAGNOSTICS, INC          510(k) NO: K110786(TRADITIONAL)
ATTN: JOHN  RIOLO                 PHONE NO : 760 448 4300   
5964 LA PLACE COURT SUITE 100     SE DECISION MADE: 02-DEC-11
CARLSBAD CA 92008                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMMULISA SCI-70 ANTIBODY ELISA
IMMCO DIAGNOSTICS, INC.           510(k) NO: K113143(TRADITIONAL)
ATTN: KEVIN J LAWSON              PHONE NO : 716 691 0091   
60 PINEVIEW DR.                   SE DECISION MADE: 02-DEC-11
BUFFALO NY 14228 2120             510(k) STATEMENT
                                  THIRD PARTY REVIEW

DEVICE: MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM
MEDAPPS, INC.                     510(k) NO: K112559(SPECIAL)
ATTN: KENT  DICKS                 PHONE NO : 480 305 6323   
7975 NORTH HAYDEN ROAD SUITE A-203SE DECISION MADE: 02-DEC-11
SCOTTSDALE AZ 85258               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM)
OMNLIFE SCIENCE                   510(k) NO: K112779(SPECIAL)
ATTN: CHRISTINE  NASSIF           PHONE NO : 774 226 1871   
50 O'CONNELL WAY SUITE 10         SE DECISION MADE: 02-DEC-11
EAST TAUNTON MA 02718             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MOBILE MIM
MIM SOFTWARE INC.                 510(k) NO: K112930(TRADITIONAL)
ATTN: LYNN  HANIGAN               PHONE NO : 216 455 0600   
25200 Chagrin Blvd. SUITE 200     SE DECISION MADE: 02-DEC-11
Cleveland OH 44122                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VANTAGE TITAN HSR
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K112003(TRADITIONAL)
ATTN: PAUL  BIGGINS               PHONE NO : 714 730 5000   
2441 MICHELLE DRIVE               SE DECISION MADE: 02-DEC-11
TUSTIN CA 92781                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AVAIRA AVAIRA TORIC AVAIRA MULTIFOCAL
COOPERVISION, INC.                510(k) NO: K113245(SPECIAL)
ATTN: GWEN  SHARP                 PHONE NO : 925 621 2457   
6150 STONERIDGE MALL ROAD SUITE 37SE DECISION MADE: 02-DEC-11
PLEASANTON CA 94588               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOPMEDICS52,52 1DAY,52 TORIC,52 1DAY TORIC
COOPERVISION, INC.                510(k) NO: K113267(SPECIAL)
ATTN: GWEN  SHARP                 PHONE NO : 925 621 2457   
6150 STONERIDGE MALL ROAD SUITE 37SE DECISION MADE: 02-DEC-11
PLEASANTON CA 94588               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS
ETHICON, INC.                     510(k) NO: K111751(TRADITIONAL)
ATTN: BRIAN A KANERVIKO           PHONE NO : 908 218 3392   
ROUTE 22 WEST                     SE DECISION MADE: 02-DEC-11
SOMERVILLE NJ 08876 0151          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAGNESIUM ASSAY
SEKISUI DIAGNOSTICS P.E.I. INC.   510(k) NO: K111915(TRADITIONAL)
ATTN: PENNY J WHITE               PHONE NO : 902 628 0934
70 WATTS AVENUE CHARLOTTETOWN     SE DECISION MADE: 02-DEC-11
PRINCE EDWARD ISLAND    CA C1E2B9 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DYNAMIC DU SERIES PORTABLE DENTAL UNIT
SHANGHAI DYNAMIC INDUSTRY CO., LTD510(k) NO: K111907(TRADITIONAL)
ATTN: DORIS  DONG                 PHONE NO : 86 21 31261348
RM 1706, NO. 128 SONGLE RD SONGJIASE DECISION MADE: 02-DEC-11
SHANGHAI    CH 201600             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANGIOJET ULTRA DVX THROMBECTOMY SET
MEDRAD, INC.                      510(k) NO: K113428(SPECIAL)
ATTN: MIKE  BURNSIDE              PHONE NO : 763 780 4555   
9055 EVERGREEN BLVD N.W.          SE DECISION MADE: 02-DEC-11
MINNEAPOLIS MN 55433 8003         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VOCARE MYHEALTH TABLET
VOCARE, INC                       510(k) NO: K111922(TRADITIONAL)
ATTN: STEVE  PEABODY              PHONE NO : 317 973 1003   
5225 EXPLORATION DRIVE            SE DECISION MADE: 02-DEC-11
INDIANAPOLIS IN 46241             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS
MEDTRONIC INC.                    510(k) NO: K113235(SPECIAL)
ATTN: AMRA  RACIC                 PHONE NO : 763 514 9383   
8200 CORAL SEA STREET NE          SE DECISION MADE: 02-DEC-11
MOUNDS VIEW MN 55112              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BENDINI(TM) SPINAL ROD BENDING SYSTEM
NUVASIVE, INC.                    510(k) NO: K111811(TRADITIONAL)
ATTN: ELIAS  KETCHUM              PHONE NO : 858 320 4588   
7475 LUSK BLVD                    SE DECISION MADE: 05-DEC-11
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EYE CARE CURE CONTACT LENS CASE
EYE CARE AND CURE                 510(k) NO: K112832(TRADITIONAL)
ATTN: LINDY V DALEN               PHONE NO : 520 321 1261   
4646 S OVERLAND DR                SE DECISION MADE: 05-DEC-11
TUCSON AZ 85714                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS
SYNTHES (USA)                     510(k) NO: K111667(SPECIAL)
ATTN: CHRISTOPHER  HACK           PHONE NO : 610 719 6940   
1301 GOSHEN PKWY.                 SE DECISION MADE: 05-DEC-11
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2
BIOSENSE WEBSTER, INC.            510(k) NO: K113213(SPECIAL)
ATTN: JOHN  JIMENEZ               PHONE NO : 909 839 8534   
3333 DIAMOND CANYON RD            SE DECISION MADE: 05-DEC-11
DIAMOND BAR CA 91765              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K112845(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK      PHONE NO : 949 706 7456   
MDI CONSULTANTS, INC. 55 NORTHERN SE DECISION MADE: 05-DEC-11
GREAT NECK NY 11021               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS)
INPRO TECHNOLOGY DEVICE FACTORY   510(k) NO: K112610(TRADITIONAL)
ATTN: MEIXIA  WANG                PHONE NO : 86 536 2197179
NO 10-1, XING'AN RD EAST LINQU    SE DECISION MADE: 05-DEC-11
WEIFANG, SHANDONG    CH 262600    510(k) STATEMENT

DEVICE: AQUAMANTYS SBS 5.0 SHEATED BIOPOLAR SEALER
SALIENT SURGICAL TECHNOLOGIES, INC510(k) NO: K111732(TRADITIONAL)
ATTN: MARTIN J LEIGHTON           PHONE NO : 603 294 5446   
180 INTERNATIONAL DRIVE           SE DECISION MADE: 05-DEC-11
Portsmouth NH 03801               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BRIVO NM 615
GE HEALTHCARE                     510(k) NO: K113350(SPECIAL)
ATTN: ELI  WERNER                 PHONE NO : 972 485 63666
4 HAYOZMA STREET                  SE DECISION MADE: 05-DEC-11
TIRAT HACARMEL    IS 30200        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES CORTICAL SCREWS
SYNTHES (USA) PRODUCTS LLC        510(k) NO: K112583(TRADITIONAL)
ATTN: REBECCA  BLANK              PHONE NO : 610 719 1268   
1303 GOSHEN PARKWAY               SE DECISION MADE: 05-DEC-11
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP)
AMEDITECH, INC.                   510(k) NO: K113501(SPECIAL)
ATTN: BRETT  CASEY                PHONE NO : 858 805 8713   
10340 CAMINO SANTA FE             SE DECISION MADE: 05-DEC-11
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AXLE PEEK INTERSPINOUS FUSION SYSTEM
X-SPINE SYSTEMS, INC              510(k) NO: K112592(SPECIAL)
ATTN: DAVID  KIRSCHMAN            PHONE NO : 937 847 8400   
452 Alexandersville Rd            SE DECISION MADE: 05-DEC-11
Miamisburg OH 45342               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT
MERIDIAN BIOSCIENCE, INC.         510(k) NO: K112125(TRADITIONAL)
ATTN: SUSAN D ROLIH               PHONE NO : 513 271 3700   
3471 RIVER HILLS DR.              SE DECISION MADE: 05-DEC-11
CINCINNATI OH 45244               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ASCENSION ATLAS HUMERAL PLATING SYSTEM
ASCENSION ORTHOPEDICS, INC.       510(k) NO: K110700(TRADITIONAL)
ATTN: SUSAN  WALTON               PHONE NO : 512 836 5001   
8700 CAMERON RD., STE. 100        SE DECISION MADE: 06-DEC-11
AUSTIN TX 78754 3832              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DENTAL 3D PLANNING SOFTWARE
SYMBYO DENTAL, LLC                510(k) NO: K113404(TRADITIONAL)
ATTN: PARUL  CHANSORIA            PHONE NO : 877 479 6296   
87 HULME CT APT.216               SE DECISION MADE: 06-DEC-11
STANFORD CA 94305                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: INFRARED EAR THERMOMETER
RADIANT INNOVATION, INC.          510(k) NO: K111637(SPECIAL)
ATTN: LYNN  CHEN                  PHONE NO : 886 3 611666
1F,NO. 3,INDUSTRIAL E. 9TH RD SCIESE DECISION MADE: 06-DEC-11
HSINCHU    TW 30075               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT
ZIMMER DENTAL INC.                510(k) NO: K111889(TRADITIONAL)
ATTN: MELISSA  BURBAGE            PHONE NO : 760 929 4300   
1900 ASTON AVE.                   SE DECISION MADE: 06-DEC-11
CARLSBAD CA 92008 7308            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPARTAN S3 FACET SYSTEM
AMENDIA, INC.                     510(k) NO: K113011(SPECIAL)
ATTN: RICH  JANSEN                PHONE NO : 612 281 5505   
13540 GUILD AVENUE                SE DECISION MADE: 06-DEC-11
APPLE VALLEY MN 55124             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISCO SUBTALAR IMPLANT
TRILLIANT SURGICAL LTD            510(k) NO: K111834(TRADITIONAL)
ATTN: J D WEBB                    PHONE NO : 512 388 0199   
1001 OAKWOOD BLVD                 SE DECISION MADE: 06-DEC-11
ROUND ROCK TX 78681               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL
MEDICA CORP.                      510(k) NO: K111363(TRADITIONAL)
ATTN: PHOTIOS  MAKRIS             PHONE NO : 781 275 4892   
5 OAK PARK DRIVE                  SE DECISION MADE: 06-DEC-11
BEDFORD MA 01730                  510(k) STATEMENT

DEVICE: NOVAPORT ONE VASCULAR ACCESS CANNULA
NOVALUNG GMBH                     510(k) NO: K112565(TRADITIONAL)
ATTN: LEANN  CHRISTMAN            PHONE NO : 734 995 9089   
3550 WEST LIBERTY RD.             SE DECISION MADE: 06-DEC-11
ANN ARBOR MI 48103                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: H-WAVE
ELECTRONIC WAVEFORM LAB, INC.     510(k) NO: K112485(TRADITIONAL)
ATTN: RYAN P HEANEY               PHONE NO : 800 874 9283   
5702 BOLSA AVE.                   SE DECISION MADE: 06-DEC-11
HUNTINGTON BEACH CA 92649         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER
EDWARDS LIFESCIENCES, LLC.        510(k) NO: K113182(SPECIAL)
ATTN: SPENCER  WALKER             PHONE NO : 801 565 6103   
12050 LONE PEAK PKWY              SE DECISION MADE: 07-DEC-11
DRAPER UT 84020                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPS
SYNERGETICS, INC                  510(k) NO: K110924(TRADITIONAL)
ATTN: GARY  OLIVEROS              PHONE NO : 636 794 5107   
3845 CORPORATE CENTRE DRIVE       SE DECISION MADE: 07-DEC-11
O'FALLON MO 63368                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DORNIER MEDILAS D LITEBEAM+ 1470
DORNIER MEDTECH AMERICA, INC.     510(k) NO: K110364(TRADITIONAL)
ATTN: JOHN  HOFFER                PHONE NO : 770 514 6163   
1155 ROBERTS BLVD.                SE DECISION MADE: 07-DEC-11
KENNESAW GA 30144                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NUZONE X2T CHEMO, POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVES POWDER FREE
TERANG NUSA SDN BHD               510(k) NO: K110698(TRADITIONAL)
ATTN: ROBERT  HILL                PHONE NO : 609 774 7171
1, JALAN 8, PENGKALAN CHEPA 2 IND.SE DECISION MADE: 07-DEC-11
KOTA BHARU, KELANTAN    MY 16100  510(k) STATEMENT

DEVICE: 3M TEGADERM MATRIX DRESSING
3M COMPANY                        510(k) NO: K110457(TRADITIONAL)
ATTN: MARIA  RUIZ                 PHONE NO : 651 736 2733   
3M CENTER, BLDG. 275-5W-06        SE DECISION MADE: 07-DEC-11
ST. PAUL MN 55133 3275            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM MODEL 8000-04944, IBGSTAR DIABETES MANAGER APPLICATION, REV D MODEL 8400-05948
AGAMATRIX INC                     510(k) NO: K103544(TRADITIONAL)
ATTN: WILLIAM H MCGRAIL           PHONE NO : 603 328 6051   
7C RAYMOND AVE                    SE DECISION MADE: 07-DEC-11
SALEM NH 03079                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ATHENA PEDICLE SCREW SYSTEM
ROYAL OAK MEDICAL DEVICES         510(k) NO: K110046(TRADITIONAL)
ATTN: MATHEW  KROLL               PHONE NO : 248 628 2830   
39533 WOODWARD AVENUE             SE DECISION MADE: 07-DEC-11
BLOOMFIELD HILLS MI 48304         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K113179(TRADITIONAL)
ATTN: ROBERT F LAWRENCE           PHONE NO : 650 694 5984   
1230 SHOREBIRD WAY                SE DECISION MADE: 07-DEC-11
MOUNTAIN VIEW CA 94043            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: JOULE CLEARSENSE LASER SYSTEM
SCITON, INC.                      510(k) NO: K111483(TRADITIONAL)
ATTN: JAY M PATEL                 PHONE NO : 650 493 9155   
925 COMMERCIAL ST.                SE DECISION MADE: 07-DEC-11
PALO ALTO CA 94303                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SWIFT FX BELLA
RESMED LTD.                       510(k) NO: K112489(SPECIAL)
ATTN: KIM K LEE                   PHONE NO : 612 888 41000
1 ELIZABETH MACARTHUR DR          SE DECISION MADE: 07-DEC-11
BELLA VISTA NEWSOUTH WALES    AS 2510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SEITY 37% PHOSPHORIC ACID ETCHANT GEL
MYCONE DENTAL SUPPLY CO., INC.    510(k) NO: K112597(TRADITIONAL)
ATTN: WILLIAM  EVANS              PHONE NO : 856 663 4700   
616 HOLLYWOOD AVE.                SE DECISION MADE: 07-DEC-11
CHERRY HILL NJ 08002              510(k) STATEMENT

DEVICE: DSJ MASSAGER
MEGO AFEK AC LTD                  510(k) NO: K112479(TRADITIONAL)
ATTN: JAMES R RAVITZ, ESQ.        PHONE NO : 202 857 8903   
1050 CONNECTICUT AVENUE, NW.      SE DECISION MADE: 07-DEC-11
WASHINGTON DC 20036               510(k) STATEMENT

DEVICE: LARGE/EXTRA LAGRE CONDOM
KAREX INDUSTRIES SDN BHD.         510(k) NO: K113061(SPECIAL)
ATTN: LAI  PENG                   PHONE NO : 607 687 8833
PTD. 7906 & 7907, TAMAN PONTIAN JASE DECISION MADE: 07-DEC-11
JOHOR DARUL TAKZIM    MY 82000    510(k) STATEMENT

DEVICE: AIR-N-GO
SATELEC                           510(k) NO: K110379(TRADITIONAL)
ATTN: RICK  ROSATI                PHONE NO : 800 289 6367   
124 GAITHER DRIVE SUITE 140       SE DECISION MADE: 08-DEC-11
MT. LAUREL NJ 08054               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SHIELD KYPHOPLASTY SYSTEM
SOTEIRA, INC.                     510(k) NO: K093477(TRADITIONAL)
ATTN: PAMELA  PAPINEAU            PHONE NO : 978 772 3552   
5 WHITCOMB AVENUE                 SE DECISION MADE: 08-DEC-11
AYER MA 01432                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRESSON ELECTRODE
PERSYST DEVELOPMENT CORP.         510(k) NO: K103103(TRADITIONAL)
ATTN: SCOTT B WILSON              PHONE NO : 858 755 4568   
3177 CLEARWATER DRIVE             SE DECISION MADE: 08-DEC-11
PRESCOTT AZ 86305                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BRUX MOUTHGUARDS
DENTAL ARTE, INC.                 510(k) NO: K111310(TRADITIONAL)
ATTN: CAROLYN  PRIMUS             PHONE NO : 941 753 9737   
7046 OWL'S NEST TERR              SE DECISION MADE: 08-DEC-11
BRADERDON FL 34203                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VARILIFT CERVICAL INTERBODY FUSION SYSTEM
WENZEL SPINE                      510(k) NO: K111123(TRADITIONAL)
ATTN: SOURABH  MISHRA             PHONE NO : 512 501 4017   
1001 OAKWOOD BLVD                 SE DECISION MADE: 08-DEC-11
ROUND ROCK TX 78681               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AQUA LUBE
MAYER LABORATORIES, INC.          510(k) NO: K110325(TRADITIONAL)
ATTN: DAVID P MAYER               PHONE NO : 510 229 5300   
1950 ADDISON STREET, SUITE 101    SE DECISION MADE: 08-DEC-11
BERKELY CA 94704 1182             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BONE PLATE; BONE SCREW
BIOMATERIALS KOREA INC.           510(k) NO: K110926(TRADITIONAL)
ATTN: KEVIN  WALLS                PHONE NO : 720 962 5412   
5401 S. COTTONWOOD CT.            SE DECISION MADE: 08-DEC-11
GREENWOOD VILLAGE CO 80121        510(k) STATEMENT

DEVICE: MODEL PM3030
OMRON HEALTHCARE, INC.            510(k) NO: K110068(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DRIVE              SE DECISION MADE: 08-DEC-11
BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READER). NOTE FOR GENERAL RADIOGRAPHY, READER IS CARBON XL2/FCR
FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K111646(TRADITIONAL)
ATTN: DEBBIE  PEACOCK             PHONE NO : 203 602 3774   
419 WEST AVE.                     SE DECISION MADE: 08-DEC-11
STAMFORD CT 06902 6300            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZAVATION CERVICAL PLATE SYSTEM
ZAVATION LLC                      510(k) NO: K112533(TRADITIONAL)
ATTN: JOHN  WALKER                PHONE NO : 601 919 1119   
501 AVALON WAY                    SE DECISION MADE: 08-DEC-11
BRANDON MS 39047                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXACTECH EQUINOXE CAGE GLENOIDS
EXACTECH, INC.                    510(k) NO: K113309(SPECIAL)
ATTN: PATRICK  HUGHES             PHONE NO : 352 327 4762   
2320 NW 66TH COURT                SE DECISION MADE: 08-DEC-11
GAINESVILLE FL 32605              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION
INOVO, INC.                       510(k) NO: K113111(SPECIAL)
ATTN: MICHAEL T DILDINE           PHONE NO : 239 643 6577   
2975 S. HORSESHOE DRIVE SUITE 600 SE DECISION MADE: 08-DEC-11
NAPLES FL 34104                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANGLED TAPERED ABUTMENT
ZIMMER DENTAL INC.                510(k) NO: K111853(TRADITIONAL)
ATTN: MELISSA  BURBAGE            PHONE NO : 760 929 4300   
1900 ASTON AVE.                   SE DECISION MADE: 08-DEC-11
CARLSBAD CA 92008 7308            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPLIT CATH III
MEDICAL COMPONENTS INC            510(k) NO: K111651(TRADITIONAL)
ATTN: JEAN  CALLOW                PHONE NO : 215 256 4201   
1499 DELP DRIVE                   SE DECISION MADE: 08-DEC-11
HARLEYSVILLE PA 19438             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIES
INTUITIVE SURGICAL, INC.          510(k) NO: K112208(TRADITIONAL)
ATTN: BRANDON  HANSEN             PHONE NO : 408 523 2100   
1266 KIFER RD                     SE DECISION MADE: 08-DEC-11
SUNNYVALE CA 94086                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER
KEELER INSTRUMENTS, INC.          510(k) NO: K112093(SPECIAL)
ATTN: EUGENE R VANARSDALE         PHONE NO : 610 353 4350   
456 PKWY.                         SE DECISION MADE: 08-DEC-11
BROOMALL PA 19008                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TUTTNAUER EZ PLUS SERIES ELECTRONIC TABLETOP AUTOCLAVES
TUTTNAUER CO. LTD.                510(k) NO: K111736(TRADITIONAL)
ATTN: THEODORE  SULLIVAN          PHONE NO : 202 452 7992   
1700 K STREET NW SUITE 300        SE DECISION MADE: 08-DEC-11
WASHINGTON DC 20006               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFIED ROG SUTURE ANCHOR
ROG SPORTS MEDICINE, INC.         510(k) NO: K112991(SPECIAL)
ATTN: CURTIS  RAYMOND             PHONE NO : 203 922 0105   
80 SHELTON TECHNOLOGY CENTER      SE DECISION MADE: 08-DEC-11
SHELTON CT 06484                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER
BAXTER HEALTHCARE CORP.           510(k) NO: K113227(SPECIAL)
ATTN: NANETTE  HEDDEN             PHONE NO : 847 270 4871   
1  BAXTER PKWY.                   SE DECISION MADE: 08-DEC-11
DEERFIELD IL 60015                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GENESYS SPINE ANTERIOR CERVICAL PLATE SYSTEM
GENESYS SPINE                     510(k) NO: K111132(TRADITIONAL)
ATTN: BRIAN J BERGERON            PHONE NO : 512 381 7071   
1250 CAPITAL OF TEXAS HWY SO. BUILSE DECISION MADE: 09-DEC-11
AUSTIN TX 78746                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THE BUZZ FACIAL TONING SYSTEM
DAKA INTERNATIONAL LTD.           510(k) NO: K102494(TRADITIONAL)
ATTN: BOB  WAGNER                 PHONE NO : 865 982 5552   
1131 ANTHEM VIEW LANE             SE DECISION MADE: 09-DEC-11
KNOXVILLE TN 37922                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RENOVIS CANNULATED SCREW SYSTEM
RENOVIS SURGICAL TECHNOLOGIES, LLC510(k) NO: K113084(SPECIAL)
ATTN: DAVID F ROTHKOPF            PHONE NO : 508 231 8842   
200 HOMER AVE.                    SE DECISION MADE: 09-DEC-11
ASHLAND MA 01721                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SARN CENTRIFUGAL PUMP
TERUMO CARDIOVASCULAR SYSTEMS     510(k) NO: K112229(TRADITIONAL)
ATTN: REBECCA  ANDERSEN           PHONE NO : 734 741 6113   
6200 JACKSON RD                   SE DECISION MADE: 09-DEC-11
ANN ARBOR MI 48103                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
ANDON HEALTH CO.,LTD              510(k) NO: K111826(SPECIAL)
ATTN: LIU  YI                     PHONE NO : 862 260 5261618060
NO 3,  JIN PING ST, YA AN RD NANKASE DECISION MADE: 09-DEC-11
TIANJIN    CH 300190              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CANADY VIEIRA HYBRID PLASMA SCALPEL
US MEDICAL INNOVATIONS LLC        510(k) NO: K113500(TRADITIONAL)
ATTN: JEROME  CANADY              PHONE NO : 863 667 1609   
2940 WINTER LAKE ROAD             SE DECISION MADE: 09-DEC-11
LAKELAND FL 33803                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ACTIV VARNISH
PULPDENT CORPORATION              510(k) NO: K112946(TRADITIONAL)
ATTN: KENNETH J BERK              PHONE NO : 617 926 6666   
80 OAKLAND ST. P.O. BOX 780       SE DECISION MADE: 09-DEC-11
WATERTOWN MA 02471 0780           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ATB ADVANCE PTA DILATATION CATHETER
COOK, INC.                        510(k) NO: K113300(SPECIAL)
ATTN: ELYSIA  POOR                PHONE NO : 812 339 2235   
750 DANIELS WAY                   SE DECISION MADE: 09-DEC-11
BLOOMINGTON IN 47404              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OSLEOBRIDGE IDSF SPACER CONECTOR
MERETE MEDICAL GMBH               510(k) NO: K113303(SPECIAL)
ATTN: EMMANUEL  ANAPLIOIS         PHONE NO : 490 307 799800
102 ALT LANKWITZ                  SE DECISION MADE: 09-DEC-11
BERLIN    GM D-12247              510(k) STATEMENT

DEVICE: EVOLUTION MP ADAPTIVE CS INSERT
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K113325(SPECIAL)
ATTN: DANIELLE  MUELLER           PHONE NO : 901 290 5904   
5677 AIRLINE RD.                  SE DECISION MADE: 09-DEC-11
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SI-LOK SACROILIAC JOINT FIXATION SYSTEM
GLOBUS MEDICAL, INC.              510(k) NO: K112028(TRADITIONAL)
ATTN: WENDY S HILLS               PHONE NO : 610 930 1800   
2560 GENERAL ARMISTEAD AVE. VALLEYSE DECISION MADE: 09-DEC-11
AUDUBON PA 19403                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRESAGE ST2 ASSAY
CRITICAL CARE DIAGNOSTICS, INC. (D510(k) NO: K111452(TRADITIONAL)
ATTN: JAMES  SNIDER               PHONE NO : 858 270 2400   
3030 BUNKER HILL STREET SUITE 115ASE DECISION MADE: 09-DEC-11
SAN DIEGO CA 92109                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NETKONNECT REMOTE NETWORK EXTENSION
NIHON KOHDEN                      510(k) NO: K112637(SPECIAL)
ATTN: STEVE  GEERDES              PHONE NO : 949 580 1555   
90 ICON                           SE DECISION MADE: 09-DEC-11
FOOTHILL RANCH CA 92610           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EBONY PTA 0.014" PERIPHERAL DILATATION CATHETER
NATEC MEDICAL LTD                 510(k) NO: K112513(TRADITIONAL)
ATTN: E.J.  SMITH                 PHONE NO : 888 729 9674   
1468 HARWELL AVENUE               SE DECISION MADE: 09-DEC-11
CROFTON MD 21114                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-7902BTJ, FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MO
ANDON HEALTH CO., LTD             510(k) NO: K111830(SPECIAL)
ATTN: LIU  YI                     PHONE NO : 86 22 60526161
No. 3 Jin Ping Street,Ya An Ro NANSE DECISION MADE: 09-DEC-11
TIANJIN    CN 300190              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CELLTRACKS ANALYER II
VERIDEX, LLC                      510(k) NO: K113181(SPECIAL)
ATTN: PATRICIA  HOJNOSKI          PHONE NO : 908 595 2473   
1001 US HIGHWAY 202 NORTH         SE DECISION MADE: 12-DEC-11
RARITAN NJ 08869 0606             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZEUS ELISA CARDIOLIPIN SCREEN TEST SYSTEM
ZEUS SCIENTIFIC, INC.             510(k) NO: K102425(TRADITIONAL)
ATTN: EWA  NADOLCZAK              PHONE NO : 908 526 3744   
200 EVANS WAY                     SE DECISION MADE: 12-DEC-11
BRANCHBURG NJ 08876               510(k) STATEMENT

DEVICE: ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING
NUCLETRON                         510(k) NO: K113102(TRADITIONAL)
ATTN: MICHEAL  PAUL               PHONE NO : 443 545 2182   
7021 Columbia Gateway Dr Suite    SE DECISION MADE: 12-DEC-11
Columbia MD 21046                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPACER-S
TECRES SPA                        510(k) NO: K112983(TRADITIONAL)
ATTN: CHRISTINE  BRAUER           PHONE NO : 301 545 1990   
7 TRAIL HOUSE COURT               SE DECISION MADE: 12-DEC-11
ROCKVILLE MD 20850                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCULIF TL CAGE
COALIGN INNOVATIONS, INC.         510(k) NO: K113465(SPECIAL)
ATTN: JUSTIN  EGGLETON            PHONE NO : 202 552 5800   
1331 H STREET NW 12TH FLOOR       SE DECISION MADE: 12-DEC-11
WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORTHOLOC 3DSI LOCKING SCREWS
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K113339(SPECIAL)
ATTN: PEGGY S RIVERS              PHONE NO : 901 867 4759   
5677 AIRLINE RD.                  SE DECISION MADE: 12-DEC-11
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARROW-LOK DIGITAL SYSTEM
ARROWHEAD MEDICAL DEVICE TECHNOLOG510(k) NO: K112675(TRADITIONAL)
ATTN: THOMAS J TWARDZIK           PHONE NO : 901 853 4366   
328 POPLAR VIEW LANE EAST SUITE 2 SE DECISION MADE: 12-DEC-11
COLLIERVILLE TN 38017             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XINGTM SPINE SYSTEM
IMPLANOVA CO. LTD                 510(k) NO: K111995(TRADITIONAL)
ATTN: APRIL  LEE                  PHONE NO : 714 525 0114   
325 N. PUENTE ST UNIT B           SE DECISION MADE: 12-DEC-11
BREA CA 92821                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OSTEOSPRING FOOTJACK SUBTALAR IMPLANT SYSTEM
OSTEOSPRING MEDICAL, INC          510(k) NO: K112658(TRADITIONAL)
ATTN: J.D.  WEBB                  PHONE NO : 512 388 0199   
228 HAMILTON AVENUE, 3RD FLOOR    SE DECISION MADE: 12-DEC-11
PALO ALTO CA 94301                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES ZERO-P
SYNTHES SPINE CO.LP               510(k) NO: K112459(SPECIAL)
ATTN: STACEY  BONNELL             PHONE NO : 610 719 5895   
1302 WRIGHTS LANE EAST            SE DECISION MADE: 12-DEC-11
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRECISION SKIN EMULSION
PRECISION DERMATOLOGY INCORPORATED510(k) NO: K111168(TRADITIONAL)
ATTN: RONALD M GURGE, PH.D        PHONE NO : 401 762 2000   
900 HIGHLAND CORPORATE DRIVE      SE DECISION MADE: 13-DEC-11
CUMBERLAND RI 02864               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES
OMEGA LABORATORIES, INC.          510(k) NO: K103161(TRADITIONAL)
ATTN: ROBERT J BARD, JD           PHONE NO : 248 563 5040   
400 NORTH CLEVELAND               SE DECISION MADE: 13-DEC-11
MOGADORE OH 44260                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VBB SYSTEM
SYNTHES                           510(k) NO: K110604(TRADITIONAL)
ATTN: JASON  LIPMAN               PHONE NO : 610 719 5629   
1302 WRIGHTS LANE EAST            SE DECISION MADE: 13-DEC-11
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEADLESS COMPRESSION SCREW
SKELETAL DYNAMICS, LLC            510(k) NO: K112672(TRADITIONAL)
ATTN: ANA M ESCAGEDO              PHONE NO : 305 596 7585   
8905 SW 87 AVENUE, SUITE 201      SE DECISION MADE: 13-DEC-11
MIAMI FL 33176                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TARGET DETACHABLE COIL
STRYKER NEUROVASCULAR             510(k) NO: K113412(SPECIAL)
ATTN: RHODA  SANTOS               PHONE NO : 510 413 2269   
47900 BAYSIDE PARKWAY             SE DECISION MADE: 13-DEC-11
FREMONT CA 94538 6515             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES HEMOSTATIC BONE PUTTY
SYNTHES (USA) PRODUCTS LLC/NORIAN 510(k) NO: K113079(TRADITIONAL)
ATTN: JEFFREY L DOW               PHONE NO : 484 356 9720   
1230 Wilson Dr                    SE DECISION MADE: 13-DEC-11
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GE INNOVA SOLID STATE XRAY IMAGER FLUROSOPIC X RAY SYSTEM
GE HEALTHCARE                     510(k) NO: K113034(TRADITIONAL)
ATTN: CAROL  ALLOIAN              PHONE NO : 847 244 8327   
9900 INNOVATION DRIVE             SE DECISION MADE: 13-DEC-11
WAUWATOSA WI 53226                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTERFACE BONE VOID FILLER
BIOSTRUCTURES, LLC                510(k) NO: K112857(TRADITIONAL)
ATTN: KEVIN A THOMAS              PHONE NO : 858 792 1235   
11234 EL CAMINO REAL SUITE 200    SE DECISION MADE: 13-DEC-11
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COUGAR SYSTEM
JOHNSON & JOHNSON                 510(k) NO: K113348(SPECIAL)
ATTN: KEVIN G STEVENS             PHONE NO : 508 977 6445   
325 PARAMOUNT DRIVE               SE DECISION MADE: 13-DEC-11
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STAXX(R) XD SYSTEM
SPINE WAVE, INC.                  510(k) NO: K111418(TRADITIONAL)
ATTN: ROAIDA  RIZKALLAH           PHONE NO : 203 944 9494   
3 ENTERPRISE DR SUITE 210         SE DECISION MADE: 13-DEC-11
SHELTON CT 06484                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIEW 1 IMAGING
KARL STORZ ENDOSCOPY AMERICA, INC.510(k) NO: K112480(TRADITIONAL)
ATTN: WINKIE  WONG                PHONE NO : 424 218 8379   
2151 E. GRAND AVENUE              SE DECISION MADE: 13-DEC-11
EL SEGUNDO CA 90245               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOMNOBRUX SPLINTS
SOMNOMED INC                      510(k) NO: K102909(TRADITIONAL)
ATTN: BRADLEY  SOUTHWORTH         PHONE NO : 940 381 5200   
7460 WARREN PARKWAY SUITE 190     SE DECISION MADE: 13-DEC-11
FRISCO TX 75034                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PSM LOMAS / BENEFIT SCREWS
PSM MEDICAL SOLUTIONS             510(k) NO: K110392(TRADITIONAL)
ATTN: ANDREA  PECSI               PHONE NO : 004 974 62924051
SCHWARZWALDSTRASSE 5              SE DECISION MADE: 14-DEC-11
TUTTLINGEN BW    GM 78532         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXSEPT SKIN AND WOUND CLEANSER WITH ANTIMICROBIAL PRESERVATIVE
ALCAVIS HDC LLC                   510(k) NO: K111313(TRADITIONAL)
ATTN: GARY J MISHKIN              PHONE NO : 301 330 7597   
8322 Helgerman CT                 SE DECISION MADE: 14-DEC-11
Gaithersburg MD 20877             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMI CARDIOVASCULAR PACH
SOLIMAS MEDICAL, INC.             510(k) NO: K112683(TRADITIONAL)
ATTN: MICHEAL  KOLBE              PHONE NO : 408 505 6626   
443 COSTA MESA TERRACE            SE DECISION MADE: 14-DEC-11
SUNNYVALE CA 94089                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TERUMO ASPRIATION CATHETER
TERUMO MEDICAL CORPORATION        510(k) NO: K112382(TRADITIONAL)
ATTN: DANIEL R PLONSKI            PHONE NO : 410 392 7395   
950 ELKTON BLVD                   SE DECISION MADE: 14-DEC-11
ELKTON MD 21921                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014" AND 0.018")
TRIREME MEDICAL, INC.             510(k) NO: K111738(SPECIAL)
ATTN: SHIVA  ARDAKAMI             PHONE NO : 925 931 1300   
7060 Koll Center Parkway Suite 300SE DECISION MADE: 14-DEC-11
Pleasanton CA 94566               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: KDL SYRINGES AND NEEDLE
SHANGHAI KINDLY ENTERPRISE DEV. GR510(k) NO: K112057(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 862 164 264467
P.O. BOX 237-023                  SE DECISION MADE: 14-DEC-11
SHANGHAI    CH 200237             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VENUS PEARL PLT REFILL A1
HERAEUS KULZER, LLC               510(k) NO: K112501(TRADITIONAL)
ATTN: CHERYL  ZIMMERMAN           PHONE NO : 574 299 5444   
300 HERAEUS WAY                   SE DECISION MADE: 14-DEC-11
SOUTH BEND IN 46614               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 4-WEB ALIF SPINAL TRUSS SYSTEM (STS)
4-WEB, INC.                       510(k) NO: K112316(SPECIAL)
ATTN: RICH  JANSEN, PHARM. D.     PHONE NO : 612 281 5505   
13540 GUILD AVE.                  SE DECISION MADE: 14-DEC-11
APPLE VALLEY MN 55124             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST
MIRADOR BIOMEDICAL, INC.          510(k) NO: K112203(TRADITIONAL)
ATTN: JUSTIN  HULVERSHORN         PHONE NO : 206 295 3372   
2815 WASTLAKE AVENUE SUITE 220    SE DECISION MADE: 14-DEC-11
SEATTLE WA 98102                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TAPERED SCREW-VENT X IMPLANT
ZIMMER DENTAL INC.                510(k) NO: K112160(TRADITIONAL)
ATTN: JEREMY  MARKOVICH           PHONE NO : 760 929 4335   
1900 ASTON AVE.                   SE DECISION MADE: 14-DEC-11
CARLSBAD CA 92008 7308            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE
HITACHI CHEMICAL DIAGNOSTICS, INC.510(k) NO: K111753(TRADITIONAL)
ATTN: ERIKA B AMMIRATI, RAC, MT (APHONE NO : 650 949 2768   
575 SHIRLYNN COURT                SE DECISION MADE: 14-DEC-11
LOS ALTOS CA 94022                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ULTRAMAXO2 OXYGEN ANALYER
MAXTEC, LLC                       510(k) NO: K112402(ABBREVIATED)
ATTN: TAMMY  LAVERY               PHONE NO : 801 266 5300   
6526 Cottonwood St # 300          SE DECISION MADE: 14-DEC-11
Salt Lake City UT 84107           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LANCER PEDICLE SCREW SYSTEM
SPINAL SOLUTIONS, LLC             510(k) NO: K110633(SPECIAL)
ATTN: J.D.  WEBB                  PHONE NO : 512 388 0199   
1001 OAKWOOD BLVD                 SE DECISION MADE: 15-DEC-11
ROUND ROCK TX 78681               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FORA PREMIUM V10 BLOOD GLUCOSE MONITORING SYSTEM
TAIDOC TECHNOLOGY CORPORATION     510(k) NO: K112275(SPECIAL)
ATTN: LINDA  KO                   PHONE NO : 886 266 258188
3F,5F, NO.127 WUGONG 2ND RD, WUGU SE DECISION MADE: 15-DEC-11
NEW TAIPEI CITY    TW 24888       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTRAORAL BELSENSOR GOLD
TAKARA BELMONT USA, INC.          510(k) NO: K102456(TRADITIONAL)
ATTN: ROBERT  SCHIFF              PHONE NO : 973 227 1830   
1129 BLOOMFIELD AVENUE            SE DECISION MADE: 15-DEC-11
WEST CALDWELL NJ 07006            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTHREX BIOCOMPOSITE TRANSFIX
ARTHREX, INC.                     510(k) NO: K112040(SPECIAL)
ATTN: SALLY  FOUST                PHONE NO : 239 643 5553   
1370 CREEKSIDE BLVD.              SE DECISION MADE: 15-DEC-11
NAPLES FL 34108 1945              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE
MEDRAD, INC.                      510(k) NO: K113133(SPECIAL)
ATTN: MIKE  BURNSIDE              PHONE NO : 763 717 1077   
ONE MEDRAD DRIVE                  SE DECISION MADE: 15-DEC-11
INDIANOLA PA 15051                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS)
BIOMET, INC.                      510(k) NO: K111746(TRADITIONAL)
ATTN: PATRICIA  SANDBORN BERES    PHONE NO : 574 267 6639   
56 EAST BELL DR. P.O. BOX 587     SE DECISION MADE: 15-DEC-11
WARSAW IN 46581 0587              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APTUS(R) DISTAL HUMERUS SYSTEM
MEDARTIS AG                       510(k) NO: K112560(TRADITIONAL)
ATTN: KEVIN A THOMAS              PHONE NO : 858 792 1235   
11234 EL CAMINO REAL SUITE 200    SE DECISION MADE: 15-DEC-11
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER
KIMBERLY-CLARK                    510(k) NO: K112562(TRADITIONAL)
ATTN: DAVID  LEE                  PHONE NO : 770 587 7167   
1400 HOLCOMB BRIDGE ROAD          SE DECISION MADE: 15-DEC-11
ROSWELL GA 30076                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
CONFORMIS, INC.                   510(k) NO: K112780(TRADITIONAL)
ATTN: AMITA S SHAH                PHONE NO : 781 345 9164   
11 NORTH AVENUE                   SE DECISION MADE: 15-DEC-11
BURLINGTON MA 01803               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROG SUTURE ANCHOR
ROG SPORTS MEDICINE, INC.         510(k) NO: K113299(SPECIAL)
ATTN: CURTIS  RAYMOND             PHONE NO : 203 922 0105   
80 SHELTON TECHNOLOGY CENTER      SE DECISION MADE: 15-DEC-11
SHELTON CT 06484                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXASLT T7 WOUND DRESSING
EXCITON TECHNOLOGIES INC.         510(k) NO: K113564(SPECIAL)
ATTN: MELANIE  USSYK              PHONE NO : 780 248 5868
Suite 4000 10230 Jasper Avenue    SE DECISION MADE: 15-DEC-11
Edmonton    CA T5J 4P6            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONE
PANPAC MEDICAL CORPORATION        510(k) NO: K102898(TRADITIONAL)
ATTN: YEN-MING  PAN               PHONE NO : 886 286 472242
NO. 202, 6F-1.2, SEC.3 TATONG ROADSE DECISION MADE: 15-DEC-11
SHI-CHIH CITY, TAIPEI HSIEN    TW 510(k) STATEMENT

DEVICE: PICO
SMITH & NEPHEW, INC.              510(k) NO: K111170(TRADITIONAL)
ATTN: TERRY  MCMAHON              PHONE NO : 727 392 1261   
970 LAKE CARILLON DR. SUITE 110   SE DECISION MADE: 15-DEC-11
ST. PETERSBURG FL 33716           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TEMPUSIC PATIENT MONITOR
REMOTE DIAGNOSTIC TECHNOLOGIES LTD510(k) NO: K113105(ABBREVIATED)
ATTN: CHRIS  HANNAN               PHONE NO : 441 256 362400
THE OLD COACH HOUSE, THE AV. FARLESE DECISION MADE: 15-DEC-11
HAMPSHIRE    UK RG25 2HT          510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: FREESTYLE GLUCOSE METER INCORPORATED INTO THE OMNIPOD INSULIN MANAGEMENT SYSTEMS
INSULET CORPORATION               510(k) NO: K111669(TRADITIONAL)
ATTN: SUSAN  FINNERAN             PHONE NO : 781 457 5234   
9 OAK PARK DR.                    SE DECISION MADE: 15-DEC-11
BEDFORD MA 01730                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACE-FISCHER(R), TEMPFIX(R), HOFFMAN CLASSIC(TM) EXTERNAL FIXATORS
DEPUY ORTHOPAEDICS, INC.          510(k) NO: K112218(TRADITIONAL)
ATTN: SUZANA  OTANO               PHONE NO : 305 269 6386   
700 ORTHOPAEDIC DRIVE             SE DECISION MADE: 15-DEC-11
WARSAW IN 46581 0988              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MSA HIP SYSTEM
GLOBAL MANUFACTURING TECHNOLOGY   510(k) NO: K113107(SPECIAL)
ATTN: HOLLACE S  RHODES           PHONE NO : 202 552 5800   
1331 H STREET NW                  SE DECISION MADE: 15-DEC-11
WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CUFFLINK(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5MM/5.5MM - PEEK ONLY, CUFFLINK SP(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5
CAYENNE MEDICAL, INC.             510(k) NO: K112876(TRADITIONAL)
ATTN: KERESHMEH  SHAHRIARI        PHONE NO : 480 502 3661   
16597 N. 92ND STREET SUITE 101    SE DECISION MADE: 15-DEC-11
SCOTTSDALE AZ 85260               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUIDEL MOLECULAR HMPV ASSAY
QUIDEL CORP.                      510(k) NO: K112490(TRADITIONAL)
ATTN: RONALD H LOLLAR             PHONE NO : 858 552 1100   
10165 MCKELLAR CT.                SE DECISION MADE: 15-DEC-11
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202
B-K MEDICAL APS                   510(k) NO: K100919(TRADITIONAL)
ATTN: RANDI  HAUERBERG            PHONE NO : 454 452 8105
MILEPARKEN 34                     SE DECISION MADE: 16-DEC-11
HERLEV    DA DK-2730              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ULTRASONIC SURGICAL UNIT
DONG IL TECHNOLOGY LTD.           510(k) NO: K110881(TRADITIONAL)
ATTN: PETER  CHUNG                PHONE NO : 412 687 3976   
300 ATWOOD                        SE DECISION MADE: 16-DEC-11
PITTSBURGH PA 15213               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MED GRAVITY SET, IMED PUMP SET
IMED TECHNOLOGY, INC.             510(k) NO: K102712(TRADITIONAL)
ATTN: BRANDON  CONVERSE           PHONE NO : 785 317 0722   
17408 TAMARON DRIVE               SE DECISION MADE: 16-DEC-11
DALLAS TX 75287                   510(k) STATEMENT

DEVICE: HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS)
I.E.M. GMBH                       510(k) NO: K110603(TRADITIONAL)
ATTN: PETER  KNIPP                PHONE NO : 49 240 29500-0
COCKERILLSTRASSE 69               SE DECISION MADE: 16-DEC-11
STOLBERG    GM 52222              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROPHECY INBONE PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K110360(TRADITIONAL)
ATTN: SARAH  HOLTGREWE            PHONE NO : 901 867 4476   
5677 AIRLINE RD.                  SE DECISION MADE: 16-DEC-11
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LANX CERVICAL SA
LANX, INC                         510(k) NO: K112388(TRADITIONAL)
ATTN: MICHAEL  FUNK               PHONE NO : 303 443 7500   
310 INTERLOCKEN PARKWAY, SUITE 120SE DECISION MADE: 16-DEC-11
BROOMFIELD CO 80021               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIQUIBAND FLOW CONTROL
MEDLOGIC GLOBAL LIMITED           510(k) NO: K110184(TRADITIONAL)
ATTN: MICHAEL  BROWNE             PHONE NO : 004 417 52209955
WESTERN WOOD WAY LANGAGE SCIENCE PSE DECISION MADE: 16-DEC-11
PLYMOUTH, DEVON    UK PL7 5BG     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: "AMECATH" AND "AMECATH UNIQATH SOFT" SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS
AMECO MEDICAL INDUSTRIES          510(k) NO: K110793(TRADITIONAL)
ATTN: RAY  KELLY                  PHONE NO : 603 809 7668   
79 BROOKLINE ROAD                 SE DECISION MADE: 16-DEC-11
MASON NH 03048                    510(k) STATEMENT

DEVICE: INTEGRITY(TM)
ELEKTA LIMITED                    510(k) NO: K112613(TRADITIONAL)
ATTN: ANDREW  HEDGES              PHONE NO : 44 129 3654201
LINAC HOUSE                       SE DECISION MADE: 16-DEC-11
CRAWLEY, WEST SUSSEX    UK RH10 9R510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NOVABONE DENTAL MORSELS - BIOACTIVE SYNTHETIC BONE GRAFT
NOVABONE PRODUCTS, LLC            510(k) NO: K112428(TRADITIONAL)
ATTN: DAVID M GAISSER             PHONE NO : 386 462 7661   
13631 PROGRESS BLVD SUITE 600     SE DECISION MADE: 16-DEC-11
ALACHUA FL 32615                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S)
NANOSPHERE, INC                   510(k) NO: K112424(TRADITIONAL)
ATTN: MARK  DEL VECCHIO           PHONE NO : 847 400 9000   
4088 COMMERCIAL AVENUE            SE DECISION MADE: 16-DEC-11
NORTHBROOK IL 60062               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RECONSTRUCTION LOCKING PLATE AND 3.5MM LOCKING SCREW
XIAMEN DOUBLE ENGLINE MEDICAL MATE510(k) NO: K112819(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 862 122 815850
P.O. BOX 237-023                  SE DECISION MADE: 16-DEC-11
SHANGHAI    CH 200237             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COMPREHENSIVE REVERSE SHOULDER
BIOMET MANUFACTURING, INC.        510(k) NO: K113121(SPECIAL)
ATTN: PATRICIA S BERES            PHONE NO : 574 267 6639   
56 EAST BELL DR.                  SE DECISION MADE: 16-DEC-11
WARSAW IN 46581 0587              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANSPACH DISSECTION TOOLS
THE ANSPACH EFFORT, INC.          510(k) NO: K113476(SPECIAL)
ATTN: JEANNETTE G DAILEY          PHONE NO : 561 627 1080   
4500 RIVERSIDE DR.                SE DECISION MADE: 16-DEC-11
Palm Bch Gdns FL 33410            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMSCO CHIMERON MEDIUM STEAM STERILIZER
STERIS CORPORATION                510(k) NO: K112055(TRADITIONAL)
ATTN: ROBERT F SULLIVAN           PHONE NO : 440 392 7695   
5960 HEISLEY ROAD                 SE DECISION MADE: 16-DEC-11
MENTOR OH 44060                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TWISTER SIDE FIRE OPTICAL FIBER DELIVERY SYSTEM
BIOLITEC MEDICAL DEVICES, INC     510(k) NO: K112987(TRADITIONAL)
ATTN: HARY  HAYES                 PHONE NO : 413 250 0779   
1349 MAIN ROAD                    SE DECISION MADE: 16-DEC-11
GRANDVILLE MA 01034               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K113647(TRADITIONAL)
ATTN: ZHAI  PEI                   PHONE NO : 867 552 6582551
MINDRAY BUILDING, KEJI 12TH RD SOUSE DECISION MADE: 16-DEC-11
NANSHAN,SHENZHEN, P.R. CHINA    CH510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: GE DATEX-OHMEDA AVANCE
DATEX-OHMEDA, INC.                510(k) NO: K112722(TRADITIONAL)
ATTN: JIM  RASKOB                 PHONE NO : 608 221 1551   
PO BOX 7550                       SE DECISION MADE: 16-DEC-11
MADISON WI 53707 7550             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PATIENT EXAMINATION GLOVE
SUQIAN RUIJANG MEDICAL SUPPLIES CO510(k) NO: K113193(TRADITIONAL)
ATTN: CHU  XIAOAN                 PHONE NO : 861 082 387441
1 JIAN XIANG YUAN NO. 209 BEI SI HSE DECISION MADE: 16-DEC-11
CHU XIAOAN    CH 100083           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HYDROCOIL EMBOLIC SYSTEM (HES)
MICROVENTION, INC.                510(k) NO: K113457(SPECIAL)
ATTN: LARAINE  PANGELINA          PHONE NO : 714 247 8000   
1311 VALENCIA AVE                 SE DECISION MADE: 16-DEC-11
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIRLIGHT DENTAL HANDPIECE
BEYES DENTAL CANADA INC           510(k) NO: K112623(TRADITIONAL)
ATTN: ANTHONY  HOPKINS            PHONE NO : 877 202 1588   
3500 SOUTH DUPONT HIGHWAY         SE DECISION MADE: 16-DEC-11
DOVER DE 19901                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INSTINCT JAVA SYSTEM
ZIMMER SPINE                      510(k) NO: K113270(TRADITIONAL)
ATTN: ELSA A LINKE                PHONE NO : 952 830 6205   
7375 BUSH LAKE ROAD               SE DECISION MADE: 16-DEC-11
EDINA MN 55439                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMMUNOCARD C. DIFFICILE GDH
MERIDIAN BIOSCIENCE, INC.         510(k) NO: K112048(TRADITIONAL)
ATTN: SUSAN  BOGAR                PHONE NO : 513 271 3700   
3471 RIVER HILLS DR.              SE DECISION MADE: 16-DEC-11
CINCINNATI OH 45244               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPOTLIGHT ACCESS SYSTEM
JOHNSON & JOHNSON                 510(k) NO: K112913(SPECIAL)
ATTN: LAURA  BLEYENDAAL           PHONE NO : 508 828 3267   
325 PARAMOUNT DRIVE               SE DECISION MADE: 16-DEC-11
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TINNITUS THERAPY SYSTEM ANM T30 CR
ANM ADAPTIVE NEUROMODULATION GMBH 510(k) NO: K112752(TRADITIONAL)
ATTN: INGRID  ROHM                PHONE NO : 49 221 4546300
IM MEDIAPARK 6D                   SE DECISION MADE: 16-DEC-11
KOLN    GM D-50670                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REMSTAR AUTO A-FLEX HT
RESPIRONICS, INC.                 510(k) NO: K113068(SPECIAL)
ATTN: FRANK  KADI                 PHONE NO : 724 387 4134   
1740 GOLDEN MILE HIGHWAY          SE DECISION MADE: 16-DEC-11
MONROEVILLE PA 15146              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISPOSABLE THERMOMETER COVERS AND SHEATHS
KANG ZE INDUSTRIAL CO. LIMITED    510(k) NO: K112289(TRADITIONAL)
ATTN: DORIS  DONG                 PHONE NO : 86 213 1261348
RM 1706 YUESHA BLDG NO 128 SONGLE SE DECISION MADE: 16-DEC-11
SONGJIANG AREA, SHANGHAI    CH 201510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SBV2, MULTICHARGER MODEL MC10V2
SLEEP PERFORMANCE D.B.A. FATIGUE S510(k) NO: K111514(TRADITIONAL)
ATTN: MARC  GOODMAN               PHONE NO : 949 398 5222   
5405 ALTON PARKWAY SUITE A530     SE DECISION MADE: 16-DEC-11
IRVINE CA 92604                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FIXATE TISSUE BAND
ANULEX TECHNOLOGIES, INC          510(k) NO: K113400(SPECIAL)
ATTN: RACHEL  KENNEDY             PHONE NO : 952 224 4000   
5600 ROWLAND ROAD, STE 280        SE DECISION MADE: 16-DEC-11
MINNETONKA MN 55343               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ER35 ERO-SCAN PRO HEARING TEST SYSTEM
ETYMOTIC RESEARCH, INC.           510(k) NO: K112733(TRADITIONAL)
ATTN: JACK  KENT                  PHONE NO : 202 822 1850   
2001 PENNSYLVANIA AVE. NW SUITE 95SE DECISION MADE: 16-DEC-11
WASHINGTON DC 20006               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SAME/VARIOUS DISTRIBUTORS/WE MAY PRIVATE LABEL
CLEAN MEDICAL MANFACTURING CO;LTD 510(k) NO: K112743(TRADITIONAL)
ATTN: AARON  RICHARD              PHONE NO : 626 964 1000   
18633 E. GALE AVE.#105            SE DECISION MADE: 16-DEC-11
CITY OF INDUSTRY CA 91748         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EASYPROPHY SERIES AIR POLISH DEVICES, MODELS EASYPROPHY 200 AND EASYPROPHY 400
BEYES DENTAL CANADA INC           510(k) NO: K112869(TRADITIONAL)
ATTN: ANTHONY  HOPKINS            PHONE NO : 877 202 1588   
3500 SOUTH DUPONT HIGHWAY         SE DECISION MADE: 16-DEC-11
DOVER DE 19901                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER
NINEPOINT MEDICAL, INC            510(k) NO: K112770(TRADITIONAL)
ATTN: CINDY  DOMECUS              PHONE NO : 650 343 4813   
1171 BARROIHET AVENUE             SE DECISION MADE: 16-DEC-11
HILLSBOROUGH CA 94010             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLEARSTART SVM SYSTEM
INTIO INC.                        510(k) NO: K113541(TRADITIONAL)
ATTN: DAVID  GUSTAFSON            PHONE NO : 303 800 3700   
325 INTERLOCKEN PARKWAY           SE DECISION MADE: 16-DEC-11
BROOMFIELD CO 80021               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ONDEMAND3D
CYBERMED, INC.                    510(k) NO: K113543(TRADITIONAL)
ATTN: YONG  KI IM                 PHONE NO : 822 339 73970
#504 SJ TECHNOVILLE, GASAN-DONG 60SE DECISION MADE: 16-DEC-11
SEOUL    KS 153-710               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: HD-IVUS ULTRASOUND IMAGING SYSTEM
SILICON VALLY MEDICAL INSTRUMENTS,510(k) NO: K112997(TRADITIONAL)
ATTN: RICHARD E ANDERSON          PHONE NO : 510 897 4695   
47697 WESTINGHOUSE SUITE 101      SE DECISION MADE: 17-DEC-11
FREMONT CA 94539                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 8MP COLOR LCD MONITOR,RADIFORCE RX840
EIZO NANAO CORPORATION            510(k) NO: K113226(TRADITIONAL)
ATTN: HIROAKI  HASHIMOTO          PHONE NO : 81 76 2742468
153 SHIMOKASHIWANO,               SE DECISION MADE: 17-DEC-11
HAKUSAN, ISHIKAWA    JA 924-8566  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOGRAPH MCT FAMILY
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K113448(SPECIAL)
ATTN: ALAINE  MEDIO               PHONE NO : 865 218 2703   
810 INNOVATION DR.                SE DECISION MADE: 17-DEC-11
KNOXVILLE TN 37932                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS
ORTHO SOLUTIONS LIMITED           510(k) NO: K110895(TRADITIONAL)
ATTN: AL  LIPPINCOTT              PHONE NO : 952 492 5858   
3150 E. 200TH STREET              SE DECISION MADE: 19-DEC-11
PRIOR LAKE MN 55372               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACEM
SANDHILL SCIENTIFIC, INC.         510(k) NO: K111013(TRADITIONAL)
ATTN: LEWIS  WARD                 PHONE NO : 303 530 3279   
4655 KIRKWOOD CT                  SE DECISION MADE: 19-DEC-11
BOULDER CO 80301                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NOFACT VIII
R2 DIAGNOSTICS, INC.              510(k) NO: K102851(TRADITIONAL)
ATTN: MARC D GOLDFORD             PHONE NO : 574 288 4377   
1801 COMMERCE DR.                 SE DECISION MADE: 19-DEC-11
SOUTH BEND IN 46628               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NOFACT IX
R2 DIAGNOSTICS, INC.              510(k) NO: K102908(TRADITIONAL)
ATTN: MARC D GOLDFORD             PHONE NO : 574 288 4377   
1801 COMMERCE DR.                 SE DECISION MADE: 19-DEC-11
SOUTH BEND IN 46628               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY
ZIMMER, INC.                      510(k) NO: K112885(TRADITIONAL)
ATTN: STEPHEN H MCKELVEY          PHONE NO : 574 372 4944   
P.O. BOX 708                      SE DECISION MADE: 19-DEC-11
WARSAW IN 46581 0708              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)
AXIS-SHIELD DIAGNOSTICS, LTD.     510(k) NO: K112443(TRADITIONAL)
ATTN: CLAIRE I DORA               PHONE NO : 044 138 2422000
THE TECHNOLOGY PARK LUNA PLACE    SE DECISION MADE: 19-DEC-11
DUNDEE,    UK DD2 1XA             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR,
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K112587(TRADITIONAL)
ATTN: REBECCA  ANDERSEN           PHONE NO : 734 741 6113   
6200 JACKSON RD.                  SE DECISION MADE: 19-DEC-11
ANN ARBOR MI 48103                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AXSOS LOCKING PLATE SYSTEM
STRYKER CORP.                     510(k) NO: K112926(TRADITIONAL)
ATTN: KELLY  KUCHARCZYK           PHONE NO : 201 831 6455   
325 CORPORATE DRIVE               SE DECISION MADE: 19-DEC-11
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDACTA-C
MEDACTA INTERNATIONAL             510(k) NO: K112862(TRADITIONAL)
ATTN: ADAM  GROSS                 PHONE NO : 805 437 7085   
4725 CALLE QUETZAL, UNIT B        SE DECISION MADE: 19-DEC-11
CAMARILLO CA 93012                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MX-7000 MICROXEL
BIO-MED U.S.A., INC.              510(k) NO: K111831(TRADITIONAL)
ATTN: YOUNG  CHI                  PHONE NO : 973 278 5222   
111 ELLISON ST.                   SE DECISION MADE: 19-DEC-11
PATERSON NJ 07505                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
LANX, INC.                        510(k) NO: K113434(SPECIAL)
ATTN: MICHAEL  FUNK               PHONE NO : 303 443 7500   
210 INTERLOCKEN PARKWAY SUITE 120 SE DECISION MADE: 19-DEC-11
BROOMFIELD CO 80021               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE
ARTHREX, INC.                     510(k) NO: K112990(TRADITIONAL)
ATTN: CHRISTINA  FLORES           PHONE NO : 239 643 5553   
1370 CREEKSIDE BLVD.              SE DECISION MADE: 19-DEC-11
NAPLES FL 34108 1945              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIPIFLOW THERMAL PULSATION SYSTEM
TEARSCIENCE, INC.                 510(k) NO: K112704(TRADITIONAL)
ATTN: CHRISTY  STEVENS            PHONE NO : 919 467 4007   
5151 MCCRIMMON PARKWAY SUITE 250  SE DECISION MADE: 19-DEC-11
MORRISVILLE NC 27560              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ECHELON 60 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL ECR60T, ECHELON 45 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL
ETHICON ENDO-SURGERY, LLC         510(k) NO: K112056(TRADITIONAL)
ATTN: ASIFA  VONHOF               PHONE NO : 513 337 3118   
4545 CREEK ROAD                   SE DECISION MADE: 19-DEC-11
CINCINNATI OH 45242               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FORA D40 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
TAIDOC TECHNOLOGY CORPORATION     510(k) NO: K101926(TRADITIONAL)
ATTN: LINDA  KO                   PHONE NO : 886 2 66258188
3F,5F, NO.127 WUGONG 2ND RD. WUGU SE DECISION MADE: 20-DEC-11
TAIPEI COUNTY    TW 24888         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOSCOPIC MONOPOLAR INSTRUMENTS AND ACCESSORIES
BEMA-GMBH & CO. KG                510(k) NO: K102921(TRADITIONAL)
ATTN: ANGELIKA  SCHERP            PHONE NO : 011 312 06125626
AMSTEL 320-1                      SE DECISION MADE: 20-DEC-11
AMSTERDAM, NOORD-HOLLAND    NL 101510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UNMIAX LAPAROSCOPIC INSTRUMENT
UNIMAX MEDICAL SYSTEMS, INC.      510(k) NO: K103508(TRADITIONAL)
ATTN: MICHAEL  LEE                PHONE NO : 886 228 096995
NO. 45, MINSHEN RD. DANSHUI TOWN  SE DECISION MADE: 20-DEC-11
TAIPEI COUNTY    TW 251           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICHELE SLEEP SCORING SYSTEMS
YOUNES SLEEP TECHNOLOGIES         510(k) NO: K112102(TRADITIONAL)
ATTN: MAGDY  YOUNES               PHONE NO : 204 943 6295
435 ELLICE AVENUE                 SE DECISION MADE: 20-DEC-11
WINNIPEG, MANITOBA    CA R3B 1Y6  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LEGION NARROW OXINIUM CRUCIATE RETAINING AND POSTERIOR STABILIZED FENORAL COMPONENTS
SMITH & NEPHEW, INC.              510(k) NO: K112941(ABBREVIATED)
ATTN: DAVID  HENLEY               PHONE NO : 901 399 6487   
7135 GOODLETT FARMS PARKWAY       SE DECISION MADE: 20-DEC-11
CORDOVA TN 38016                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE
ABBOTT PONT OF CARE INC           510(k) NO: K112430(TRADITIONAL)
ATTN: YUKO  HARTLEY               PHONE NO : 609 454 9271   
400 COLLEGE ROAD EAST             SE DECISION MADE: 20-DEC-11
PRINCETON NJ 08540                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DUOFERTILITY
CAMBRIDGE TEMPERATURE CONCEPTS LTD510(k) NO: K102499(TRADITIONAL)
ATTN: SCOTT R MACKIE              PHONE NO : 617 803 1026   
P.O. BOX 390930                   SE DECISION MADE: 20-DEC-11
CAMBRIDGE MA 02139                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IFS SUBTALAR IMPLANT
INTERNAL FIXATION SYSTEMS, INC.   510(k) NO: K113399(TRADITIONAL)
ATTN: CHRIS  ENDARA               PHONE NO : 305 884 5993   
10100 N.W. 116TH WAY, STE. 18     SE DECISION MADE: 20-DEC-11
MIAMI FL 33178                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIRECT ANTIBIOTIC INFUSION KIT
SUMMIT MEDICAL PRODUCTS, INC      510(k) NO: K113043(TRADITIONAL)
ATTN: MARKO V AMEN                PHONE NO : 801 352 1888   
2480 S Main St Ste 212            SE DECISION MADE: 20-DEC-11
Salt Lake Cty UT 84115            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELM PTA BALLON DILATATION CATHETER
CREAGH MEDICAL LTD                510(k) NO: K113468(SPECIAL)
ATTN: MAUREEN  O'CONNELL          PHONE NO : 978 207 1245   
5 TIMBER LANE                     SE DECISION MADE: 20-DEC-11
NORTH READING MA 01864            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEALIX KNOTLESS ANCHOR
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K113534(SPECIAL)
ATTN: DEEP  PAL                   PHONE NO : 508 977 3998   
325 PARAMOUNT DR.                 SE DECISION MADE: 20-DEC-11
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KIM
NEOMEDIC INTERNATIONAL S.L.       510(k) NO: K103022(TRADITIONAL)
ATTN: JEFFREY R SHIDEMAN          PHONE NO : 952 835 4018   
7307 GLOUCHESTER DRIVE            SE DECISION MADE: 20-DEC-11
EDINA MN 55435                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PDS(TM) BARBED SUTURES
ETHICON, INC.                     510(k) NO: K113004(TRADITIONAL)
ATTN: PETER  CECCHINI             PHONE NO : 908 218 2457   
ROUTE 22 WEST P.O. BOX 151        SE DECISION MADE: 20-DEC-11
SOMERVILLE NJ 08876 0151          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLYDESDALE(R) SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K113528(SPECIAL)
ATTN: BECKY  RONNER               PHONE NO : 901 399 2757   
1800 PYRAMID PLACE                SE DECISION MADE: 20-DEC-11
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDISISS REPROCESSED ARTHROSCOPIC SHAVERS AND BURS
MEDISISS                          510(k) NO: K113028(TRADITIONAL)
ATTN: JOYCE  ELKINS               PHONE NO : 541 923 3310   
2747 SW 6TH STREET                SE DECISION MADE: 20-DEC-11
REDMOND OR 97756                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 21.3INCH (54CM)COLOR LCD MONITOR CCL256I2(CL21256)
TOTOKU ELECTRIC CO., LTD          510(k) NO: K113136(TRADITIONAL)
ATTN: TSUKASA  TASHIRO            PHONE NO : 81 258 246611
300 OYA                           SE DECISION MADE: 20-DEC-11
UEDA, NAGANO    JA 386-0192       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWER-LOAD COT FASTENER SYSTEM
STRYKER MEDICAL                   510(k) NO: K113598(TRADITIONAL)
ATTN: RENATA  SILA                PHONE NO : 269 389 6689   
3800 E. CENTRE AVE.               SE DECISION MADE: 20-DEC-11
PORTAGE MI 49002                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: METRON-CP/MD
EPONATECH LLC                     510(k) NO: K103554(ABBREVIATED)
ATTN: K. BRIAN  MATLOCK           PHONE NO : 925 944 7131   
1485 TREAT BOULEVARD SUITE 200    SE DECISION MADE: 20-DEC-11
WALNUT CREEK CA 94597             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIMACORPORATE SMR REVERSE SHOULDER SYSTEM
LIMACORPORATE S.P.A.              510(k) NO: K113523(SPECIAL)
ATTN: CHERYL  HASTINGS            PHONE NO : 574 527 4220   
P.O. BOX 696                      SE DECISION MADE: 20-DEC-11
WINONA LAKE IN 46590 696          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM
ABBOTT MEDICAL OPTICS INC         510(k) NO: K111446(TRADITIONAL)
ATTN: ROSANNE M YETEMIAN          PHONE NO : 714 247 8282   
1700 EAST SAINT ANDREW PL         SE DECISION MADE: 21-DEC-11
SANTA ANA CA 92705                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GALAXY SYSTEM; JUPITER
PERSONAL HEALTH INSTITUTE INTERNAT510(k) NO: K111055(TRADITIONAL)
ATTN: KUMAR  KULKARNI             PHONE NO : 
263 CEDAR CREEK DRIVE             SE DECISION MADE: 21-DEC-11
BATTLE CREEK MI 49015             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: "AMECATH CVC" AND "AMECATH PRESSURE CVC" SHORT TERM SINGLE AND MULTI-LUMEN CATHERIZATION KITS
AMECO MEDICAL INDUSTRIES          510(k) NO: K110794(TRADITIONAL)
ATTN: RAY  KELLY                  PHONE NO : 603 809 7668   
79 BROOKLINE ROAD                 SE DECISION MADE: 21-DEC-11
MASON NH 03048                    510(k) STATEMENT

DEVICE: DERMATOLOGICAL TREATMENT DEVICE FAMILY
SHARPLIGHT TECHNOLOGIES LTD.      510(k) NO: K111303(TRADITIONAL)
ATTN: ILAN  SHARON                PHONE NO : 972 528 704904
P.O. BOX 4262                     SE DECISION MADE: 21-DEC-11
ZICHRON YAACOV    IS 30900        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: U-RIGHT TD-3135 BLOOD PRESSURE MONITORING SYSTEM
TAIDOC TECHNOLOGY CORPORATION     510(k) NO: K112274(SPECIAL)
ATTN: LINDA  KO                   PHONE NO : 886 266 258188
3F, 5F, NO 127 WUGONG 2ND RD WUGU SE DECISION MADE: 21-DEC-11
NEW TAIPEI CITY    TW 24888       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: N-HYBRIDE-COMPOSITE LC FLOW
VOCO GMBH                         510(k) NO: K113444(SPECIAL)
ATTN: T.  GERKENSMEIER            PHONE NO : 494 721 719200
ANTON-FLETTNER-STRASSE 1-3        SE DECISION MADE: 21-DEC-11
CUXHAVEN    GM D-27472            510(k) STATEMENT

DEVICE: ARTHREX FRACTURE SYSTEM
ARTHREX, INC.                     510(k) NO: K112437(TRADITIONAL)
ATTN: COURTNEY  SMITH             PHONE NO : 239 643 5553   
1370 CREEKSIDE BLVD.              SE DECISION MADE: 21-DEC-11
NAPLES FL 34108 1945              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MYSENSE HEART
CARDIAC SCIENCE CORPORATION       510(k) NO: K113176(TRADITIONAL)
ATTN: NEIL  SHELLER               PHONE NO : 425 402 2156   
3303 MONTE VILLA PKWY.            SE DECISION MADE: 21-DEC-11
BOTHELL WA 98021                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: N-HYBRIDE-COMPOSITE LC
VOCO GMBH                         510(k) NO: K113563(SPECIAL)
ATTN: M.TH.  PLAUMANN             PHONE NO : 494 721 7190
ANTON-FLETTNER-STRASSE 1-3        SE DECISION MADE: 21-DEC-11
CUXHAVEN    GM D-27472            510(k) STATEMENT

DEVICE: SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES
SYNTHES INC                       510(k) NO: K113251(SPECIAL)
ATTN: ALAN  HALEY                 PHONE NO : 484 356 9763   
1302 GOSHEN PARKWAY               SE DECISION MADE: 21-DEC-11
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FM-9000 PLUS FETAL AND MATERNAL MONITOR
ADVANCED INSTRUMENTATIONS, INC.   510(k) NO: K112317(TRADITIONAL)
ATTN: JORGE  MILLAN               PHONE NO : 305 925 1260   
601 WEST 20 ST                    SE DECISION MADE: 21-DEC-11
HIALEAH FL 33010                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RANGE SPINAL SYSTEM (MESA AND DENALI)
K2M, INC.                         510(k) NO: K112920(SPECIAL)
ATTN: NANCY  GIEZEN               PHONE NO : 703 777 3155   
751 MILLER DR.,SE                 SE DECISION MADE: 21-DEC-11
LEESBURG VA 20175                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROCLEAR TORIC XR, PROCLEAR MULTIFOCAL XR, PROCLEAR MULTIFOCAL TORIC, PROCLEAR SPHERE & ASPHERE, TORIC CONTACT LENSES
COOPER VISION, INC.               510(k) NO: K112302(TRADITIONAL)
ATTN: LISA  HAHN                  PHONE NO : 585 385 6810   
6150 STONERIDGE MALL ROAD         SE DECISION MADE: 21-DEC-11
PLEASANTON CA 94588               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FRESENIUS 2008T HEMODIALYSIS MACHINE
FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K113427(SPECIAL)
ATTN: DENISE  OPPERMANN           PHONE NO : 781 699 4479   
920 WINTER STREET                 SE DECISION MADE: 21-DEC-11
WALTHAM MA 02451 1457             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FUKUDA DENSHI VASERA MODEL VS-1500
FUKUDA DENSHI USA, INC.           510(k) NO: K112521(TRADITIONAL)
ATTN: DOUG  BLAKELY               PHONE NO : 425 881 7737   
17725 N.E. 65TH ST., BLDG. C      SE DECISION MADE: 21-DEC-11
REDMOND WA 98052 4911             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OPTIMEDICA CATALYS PRECISION LASER SYSTEM
OPTIMEDICA CORPORATION            510(k) NO: K113479(TRADITIONAL)
ATTN: ALAN  MARQUARDT             PHONE NO : 408 850 8600   
3100 CORONADO DRIVE               SE DECISION MADE: 21-DEC-11
SANTA CLARA CA 95054              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TCX-I REMOTE CARE MANAGEMENT SYSTEM
BL HEALTHCARE, INC.               510(k) NO: K113493(SPECIAL)
ATTN: MICHEAL  MATHUR             PHONE NO : 508 543 4150   
33 COMMERCIAL ST., SUITE #3       SE DECISION MADE: 21-DEC-11
FOXBORO MA 02035                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EMBRYO VIEWER SOFTWARE
UNISENSE FERTILITECH A/S          510(k) NO: K113075(TRADITIONAL)
ATTN: METTE  MUNCH                PHONE NO : 458 944 9500
TUEAGER 1                         SE DECISION MADE: 21-DEC-11
ARRHUS N    DA DK-8200            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XPRESS MULTI-SINUS DILATION TOOL
ENTELLUS MEDICAL, INC.            510(k) NO: K112506(SPECIAL)
ATTN: KAREN E PETERSON            PHONE NO : 763 463 7066   
6705 WEDGWOOD COURT NORTH         SE DECISION MADE: 21-DEC-11
MAPLE GROVE MN 55311              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUREFLO MONITORING SYSTEM
TRANSONIC SYSTEMS, INC.           510(k) NO: K112657(TRADITIONAL)
ATTN: DAVID  KLEMENTOWSKI         PHONE NO : 607 257 5300   
34 DUTCH MILL RD. WARREN RD. BUSINSE DECISION MADE: 21-DEC-11
ITHACA NY 14850                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES MIRS
SYNTHES SPINE                     510(k) NO: K113044(TRADITIONAL)
ATTN: HEATHER  GUERIN             PHONE NO : 610 719 5432   
1302 WRIGHTS LN EAST              SE DECISION MADE: 21-DEC-11
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CELL-DYN EMERALD 22 SYSTEM
ABBOT LABORATORIES                510(k) NO: K110381(TRADITIONAL)
ATTN: MICHELLE B ROEDING          PHONE NO : 408 982 4800   
5440 PATRICK HENRY DR.            SE DECISION MADE: 22-DEC-11
SANTA CLARA CA 95054              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME
CARDIO COMM SOLUTIONS, INC.       510(k) NO: K111159(TRADITIONAL)
ATTN: JONATHAN  WARD              PHONE NO : 813 645 2855   
962 ALLEGRO LANE                  SE DECISION MADE: 22-DEC-11
APOLLO BEACH FL 33572             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SENOGRAPHE DS, SENOGRAPHE ESSENTIAL
GENERAL ELECTRIC COMPANY          510(k) NO: K110798(TRADITIONAL)
ATTN: STEVEN  KACHELMEYER         PHONE NO : 262 548 2432   
3000 NORTH GRANDVIEW BLVD.        SE DECISION MADE: 22-DEC-11
WAUKESHA WI 53188                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CELL-DYN 22 PLUS CALIBRATOR
STRECK                            510(k) NO: K111204(TRADITIONAL)
ATTN: DEBORAH  KIPP               PHONE NO : 402 537 5215   
7002 SOUTH 109TH ST.              SE DECISION MADE: 22-DEC-11
OMAHA NE 68128                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CELL-DYN 22 PLUS CONTROL
STRECK                            510(k) NO: K111211(TRADITIONAL)
ATTN: DEBORAH  KIPP               PHONE NO : 402 537 5215   
7002 SOUTH 109TH ST.              SE DECISION MADE: 22-DEC-11
OMAHA NE 68128                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BLUE SKY BIO TCP
BLUE SKY BIO, LLC                 510(k) NO: K110198(TRADITIONAL)
ATTN: MICHELE  VOVOLKA            PHONE NO : 847 856 0355   
888 E BELVIDERE RD. SUITE 212     SE DECISION MADE: 22-DEC-11
GRAYSLAKE IL 60030                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KOO SMALL VOLUME NEBULIZER (SVN)
KOO(SHANGHAI)INDUSTRIES CO., LTD. 510(k) NO: K112041(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DRIVE              SE DECISION MADE: 22-DEC-11
BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PENCAN SPINAL NEEDLE
B. BRAUN MEDICAL, INC.            510(k) NO: K112515(TRADITIONAL)
ATTN: LISA  GIAQUINTO             PHONE NO : 610 596 0500   
901 MARCON BLVD.                  SE DECISION MADE: 22-DEC-11
ALLENTOWN PA 18109 9341           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VARI-LASE WIREFIBER LASER FIBER
VASCULAR SOLUTIONS, INC.          510(k) NO: K113140(SPECIAL)
ATTN: JENIFER  RUETHER            PHONE NO : 763 656 4300   
6464 SYCAMORE COURT               SE DECISION MADE: 22-DEC-11
MINNEAPOLIS MN 55369              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1
ACARE TECHNOLOGY CO., LTD.        510(k) NO: K111617(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 86 21 22815850
P.O. BOX 237-023                  SE DECISION MADE: 22-DEC-11
SHANGHAI    CH 200237             510(k) STATEMENT

DEVICE: SYNAPSE MPR FUSION
FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K113244(SPECIAL)
ATTN: DEBBIE  PEACOOK             PHONE NO : 203 602 3774   
419 WEST AVE.                     SE DECISION MADE: 22-DEC-11
STAMFORD CT 06902 6300            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLLECTION DEVICE
ORTHO KINEMATICS, INC.            510(k) NO: K112109(TRADITIONAL)
ATTN: JOHN J SMITH                PHONE NO : 202 637 3638   
555 13TH STREET NW                SE DECISION MADE: 22-DEC-11
WASHINGTON DC 20005 3096          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COLLAGEN TENDON SHEET
ROTATION MEDICAL, INC.            510(k) NO: K112423(TRADITIONAL)
ATTN: JEFF  SIMS                  PHONE NO : 763 746 7502   
15350 25TH AVENUE N SUITE 100     SE DECISION MADE: 22-DEC-11
PLYMOUTH MN 55447                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MANUJET III
VBM MEDIZINTECHNIK GMBH           510(k) NO: K112783(TRADITIONAL)
ATTN: ANKE  BLOCHER               PHONE NO : 49 745 4959666
1, EINSTEINSTRASSE SULZ AM NECKAR,SE DECISION MADE: 22-DEC-11
BADEN-WURTTEMBERG    GM 72172     510(k) STATEMENT

DEVICE: IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS
PHADIA US INC.                    510(k) NO: K111919(TRADITIONAL)
ATTN: MARTIN  MANN                PHONE NO : 269 492 1957   
4169 COMMERCIAL AVE.              SE DECISION MADE: 22-DEC-11
PORTAGE MI 49002                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUIDEL MOLECULAR INFLUENZA A + B ASSAY
QUIDEL CORP.                      510(k) NO: K112172(TRADITIONAL)
ATTN: RONALD  LOLLAR              PHONE NO : 858 552 1100   
10165 MCKELLAR CT.                SE DECISION MADE: 22-DEC-11
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COLS PEEK
FOURNITURES HOSPITALIERES INDUSTRI510(k) NO: K113591(TRADITIONAL)
ATTN: PATRICIA  DONNARD           PHONE NO : 332 985 56895
ZI DE KERNEVEZ-6 RUE NOBEL        SE DECISION MADE: 22-DEC-11
QUIMPER    FR 29000               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER
TOMOTHERAPY INCORPORATED          510(k) NO: K112776(TRADITIONAL)
ATTN: GREG  BANGE                 PHONE NO : 608 830 3605   
1240 DEMING WAY                   SE DECISION MADE: 22-DEC-11
MADISON WI 53717 1954             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G
MEDOS INTERNATIONAL SARL          510(k) NO: K112907(TRADITIONAL)
ATTN: ROBIN  DINARDO              PHONE NO : 508 828 3218   
325 PARAMOUNT DRIVE               SE DECISION MADE: 22-DEC-11
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROCHE ACETAMINOPHEN ASSAY
ROCHE DIAGNOSTICS                 510(k) NO: K110726(TRADITIONAL)
ATTN: ANGELO  PEREIRA             PHONE NO : 317 521 3544   
9115 HAGUE ROAD                   SE DECISION MADE: 23-DEC-11
INDIANAPOLIS IN 46250 0416        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM
KONICA MINOLTA MEDICAL & GRAPHIC, 510(k) NO: K110717(TRADITIONAL)
ATTN: JILLIAN M REED              PHONE NO : 203 459 0659   
25 WALNUT STREET                  SE DECISION MADE: 23-DEC-11
MONROE CT 06468                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TINA-QUANT HBA1C GEN.2
ROCHE DIAGNOSTICS                 510(k) NO: K110313(TRADITIONAL)
ATTN: SUSAN  HOLLANDBECK          PHONE NO : 317 521 3380   
9115 HAGUE ROAD                   SE DECISION MADE: 23-DEC-11
INDIANAPOLIS IN 46250             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 21.3 INCH (54 CM) MONOCHROME LCD MONITOR MS23I2 (ML21023)
TOTOKU ELECTRIC CO., LTD.         510(k) NO: K113443(TRADITIONAL)
ATTN: TSUKASA  TASHIRO            PHONE NO : 812 582 46611
300 OYA                           SE DECISION MADE: 23-DEC-11
UEDA    JA 386-0192               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOMERIX COMPOSITE SURGICAL MESH
BIOMERIX CORPORATION              510(k) NO: K112499(TRADITIONAL)
ATTN: CHRISTINA L KICHULA         PHONE NO : 510 933 1222   
47757 FREMONT BLVD                SE DECISION MADE: 23-DEC-11
FREMONT CA 94538                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AU5800(R) CHEMISTRY ANALYZER
BECKMAN COULTER, INC.             510(k) NO: K112412(TRADITIONAL)
ATTN: DAVID G DAVIS               PHONE NO : 469 236 8180   
250 S. KRAEMER BOULEVARD MAIL STOPSE DECISION MADE: 23-DEC-11
BREA CA 92821                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EASY TOUCH
MHC MEDICAL PRODUCTS, LLC         510(k) NO: K112789(TRADITIONAL)
ATTN: DANIEL  KAMM                PHONE NO : 239 234 1735   
8870 RAVELLO CT.                  SE DECISION MADE: 23-DEC-11
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MED-RX EXTENSION SET WITH T-CONNECTOR
BENLAN INC                        510(k) NO: K112799(TRADITIONAL)
ATTN: CHERYL  BROWN               PHONE NO : 905 829 5004
2760 BRIGHTON RD                  SE DECISION MADE: 23-DEC-11
OAKVILLE    CA L6H 5T4            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 1.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL
INVIVO CORPORATION                510(k) NO: K111673(TRADITIONAL)
ATTN: ELIZABETH  WHEELER          PHONE NO : 352 336 0010   
3545 S.W. 47TH AVE.               SE DECISION MADE: 23-DEC-11
GAINESVILLE FL 32608              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DR. GREENSBURG'S HYBRID
ALWAYS MORE MARKETING INC         510(k) NO: K111680(ABBREVIATED)
ATTN: JONATHAN  GREENBURG         PHONE NO : 818 414 4817   
4535 W. SAHARA AVE., STE 200      SE DECISION MADE: 23-DEC-11
LAS VEGAS NV 89102                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STRYKER RESORBABLE FIXATION SYSTEM
STRYKER                           510(k) NO: K113109(SPECIAL)
ATTN: MANISH  PATEL               PHONE NO : 269 389 4271   
750 TRADE CENTER WAY STE 200      SE DECISION MADE: 23-DEC-11
PORAGE MI 49002                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOMERIX ASSURE
BIOMERIX CORPORATION              510(k) NO: K112567(TRADITIONAL)
ATTN: CHRISTINA L KICHULA         PHONE NO : 510 933 1222   
47757 FREMONT BLVD                SE DECISION MADE: 23-DEC-11
FREMONT CA 94538                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
EPS BIO TECHNOLOGY CORP.          510(k) NO: K112901(SPECIAL)
ATTN: CYNTHIA  HUNG               PHONE NO : 886 366 86868
No.8, R&D Rd. III, Hsinchu ScienceSE DECISION MADE: 23-DEC-11
HSINCHU CITY    TW 30077          510(k) STATEMENT

DEVICE: GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT
BIONOSTICS, INC.                  510(k) NO: K112352(TRADITIONAL)
ATTN: RANDY  BYRD                 PHONE NO : 978 772 7070   
7 JACKSON RD.                     SE DECISION MADE: 23-DEC-11
DEVENS MA 01434                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZAVATION IBF SYSTEMS
ZAVATION LLC                      510(k) NO: K112664(TRADITIONAL)
ATTN: JOHN  WALKER                PHONE NO : 601 919 1119   
501 AVALON WAY                    SE DECISION MADE: 23-DEC-11
BRANDON MS 39047                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCESS THYROGLOBULIN ANITBODY
BECKMAN COULTER, INC.             510(k) NO: K112933(SPECIAL)
ATTN: GERALDINE L BAGLIEN         PHONE NO : 952 368 7645   
1000 LAKE HAZELTINE DR.           SE DECISION MADE: 27-DEC-11
CHASKA MN 55318 1084              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GEISTLICH PERIO-SYSTEM COMBI-PACK , GEISTLICH BIO-GIDE PERIO
GEISTLICH PHARMA AG               510(k) NO: K112575(TRADITIONAL)
ATTN: DANIEL A KRACOV             PHONE NO : 202 942 5120   
555 TWELFTH STREET, NW            SE DECISION MADE: 27-DEC-11
WASHINGTON DC 20004 1206          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROCEDURE REHEARSAL STUDIO(TM)
SIMBIONIX LTD.                    510(k) NO: K112387(SPECIAL)
ATTN: SHOSHANA  FRIEDMAN          PHONE NO : 704 899 0092   
1914 J N PEASE PL.                SE DECISION MADE: 27-DEC-11
CHARLOTTE NC 28262                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOWRIST ONE VESSEL SEALER
INTUITIVE SURGICAL, INC.          510(k) NO: K110639(TRADITIONAL)
ATTN: BRANDON  HANSEN             PHONE NO : 408 523 2100   
1266 KIFER ROAD                   SE DECISION MADE: 28-DEC-11
SUNNYVALE CA 94086                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CERAMIR CROWN & BRIDGE
DOXA DENTAL AB                    510(k) NO: K113040(ABBREVIATED)
ATTN: MARGARETH  JORVID           PHONE NO : 46 70 5192640
AXEL JOHANSSONS, GATA 4-6         SE DECISION MADE: 28-DEC-11
UPPSALA    SW SE-754 51           510(k) STATEMENT

DEVICE: AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION
NATUS MEDICAL INCORPORATED        510(k) NO: K111618(TRADITIONAL)
ATTN: CHARLES L MORIN             PHONE NO : 415 957 0101   
388 MARKET STREET SUITE 1460      SE DECISION MADE: 28-DEC-11
SAN FRANCISCO CA 94111            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NNC CEMENTABLE ABUTMENT STRAIGHT,15 DEGREE ANGLE, TYPE A ,15 DEGREE ANGLE, TYPE B,NNC BASAL SCREW  CEMENTABLE ABUTMENTS
STRAUMANN USA                     510(k) NO: K113283(SPECIAL)
ATTN: ELAINE  ALAN                PHONE NO : 978 747 2513   
60 MINUTETEMAN ROAD               SE DECISION MADE: 28-DEC-11
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SEASPINE MONOPOLAR PROBE SYSYEM
SEASPINE, INC.                    510(k) NO: K111671(TRADITIONAL)
ATTN: DAN  MILLER                 PHONE NO : 760 727 8399   
2302 LA MIRADA DR.                SE DECISION MADE: 28-DEC-11
VISTA CA 92081 7862               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WALLFLEX BILIARY TRANSHEPATIC UNCOVERED STENT SYSTEM, WALLFLEX BILIARY TRANSHEPATIC COVERED STENT SYSTEM
BOSTON SCIENTIFIC CORPORATION     510(k) NO: K112543(TRADITIONAL)
ATTN: THOMAS  HIRTE               PHONE NO : 508 683 4454
100 BOSTON SCIENTIFIC WAY         SE DECISION MADE: 29-DEC-11
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA
RAYENCE CO., LTD                  510(k) NO: K113630(SPECIAL)
ATTN: DAVE  KIM                   PHONE NO : 713 467 2607   
12946 KIMBERLEY LN                SE DECISION MADE: 29-DEC-11
HOUSTON TX 77079                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
FLEXIBLE STENTING SOLUTIONS, INC. 510(k) NO: K112522(TRADITIONAL)
ATTN: JOSEPH C GRIFFIN III        PHONE NO : 732 578 0060   
23 CHRISTOPHER WAY SUITE 103      SE DECISION MADE: 30-DEC-11
EATONTOWN NJ 07724                510(k) STATEMENT

DEVICE: HANAROSTENT BILIARY (NNN)
M.I. TECH CO., LTD.               510(k) NO: K111149(TRADITIONAL)
ATTN: PAUL  SUMNER                PHONE NO : 770 449 7529   
1733 CANTON LANE                  SE DECISION MADE: 30-DEC-11
MARIETTA GA 30062                 510(k) SUMMARY AVAILABLE FROM FDA


                                                 TOTAL 510(k)s THIS PERIOD   295                                     
                                                 TOTAL WITH SUMMARIES        273                                     
                                                 TOTAL WITH STATEMENTS        22