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510(k)s Final Decisions Rendered for December 2004 |
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-DEC-2004 THROUGH 31-DEC-2004 DEVICE: A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODELS U A & D ENGINEERING, INC. 510(k) NO: K042967(SPECIAL) ATTN: JERRY WANG PHONE NO : 408-518-5113 1555 MCCANDLESS DR. SE DECISION MADE: 03-DEC-04 MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUDIT MICROCV GENERAL CHEMISTRY LINEARITY SET AALTO SCIENTIFIC LTD. 510(k) NO: K042318(TRADITIONAL) ATTN: ALAN J VEKICH PHONE NO : 760-431-7922 1959 KELLOGG AVE. SE DECISION MADE: 09-DEC-04 CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AEQUOS AAP IMPLANTATE AG 510(k) NO: K033260(TRADITIONAL) ATTN: MARC SEEGERS PHONE NO : 493 075 019192 LORENZWEG 5 SE DECISION MADE: 07-DEC-04 BERLIN, GERMANY 12099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DAPTOMYCIN AB BIODISK 510(k) NO: K042392(TRADITIONAL) ATTN: ANNE BOLMSTROM PHONE NO : 46 8 7300760 DALVAGEN 10 SE DECISION MADE: 13-DEC-04 SOLNA, SWEDEN 16956 510(k) STATEMENT DEVICE: MINI-GAMMA CAMERA, MODELS MGC500-101U AND MGC500-301U ACRORAD CO., LTD. 510(k) NO: K043293(SPECIAL) ATTN: T. WHIT ATHEY PHONE NO : 301-570-0013 2305 GOLD MINE ROAD SE DECISION MADE: 17-DEC-04 BROOKEVILLE, MD 20833 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508 ACUMEN MEDICAL, INC. 510(k) NO: K042381(TRADITIONAL) ATTN: MARYBETH GAMBER PHONE NO : 650-352-5700 1400 TERRA BELLA BLVD. SE DECISION MADE: 28-DEC-04 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLLA CANNULATED INTERFERENCE SCREW ADVANCED BIOMATERIALS 510(k) NO: K032830(TRADITIONAL) ATTN: STEVE JANIN PHONE NO : 410-761-9411 504 MCCORMICK DRIVE SE DECISION MADE: 14-DEC-04 SUITE T 510(k) SUMMARY AVAILABLE FROM FDA GLEN BURNIE, MD 21061 DEVICE: AESCULAP STERRAD 100S COMPATABLE STERILCONTAINER AESCULAP 510(k) NO: K040865(TRADITIONAL) ATTN: MATTHEW M HULL PHONE NO : 610-797-9300 3773 CORPORATE PKWY. SE DECISION MADE: 06-DEC-04 CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BICONTACT HIP SYSTEM WITH U-CAP AESCULAP 510(k) NO: K043079(SPECIAL) ATTN: KATHY A RACOSKY PHONE NO : 800-258-1946 3773 CORPORATE PKWY. SE DECISION MADE: 08-DEC-04 CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REUSABLE STERILCONTAINER FILTER MODEL #JK090 AESCULAP, INC. 510(k) NO: K041623(TRADITIONAL) ATTN: MATTHEW M HULL PHONE NO : 800-258-1946 3773 CORPORATE PKWY. SE DECISION MADE: 13-DEC-04 CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX) AESCULAP, INC. 510(k) NO: K043041(SPECIAL) ATTN: MATTHEW M HULL PHONE NO : 610-797-9300 3773 CORPORATE PKWY. SE DECISION MADE: 09-DEC-04 CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: PNEUTON VENTILATOR AIRON CORPORATION 510(k) NO: K043085(SPECIAL) ATTN: ERIC GJERDE PHONE NO : 321-821-9433 17 EAST MELBOURNE AVE. SE DECISION MADE: 20-DEC-04 MELBOURNE, FL 32901 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDLEY PCA MODULE, MODEL 8600 ALARIS MEDICAL SYSTEMS, INC. 510(k) NO: K043299(TRADITIONAL) ATTN: STACY L LEWIS PHONE NO : 858-458-7830 10221 WATERIDGE CIR. SE DECISION MADE: 10-DEC-04 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALL FLOW PULMONARY FUNCTION FILTER ALLIANCE TECH MEDICAL, INC. 510(k) NO: K043148(TRADITIONAL) ATTN: KEITH LOWREY PHONE NO : 541-476-1628 611 SOUTH SCHOOLHOUSE CREEK RD SE DECISION MADE: 13-DEC-04 GRANTS PASS, OR 97526 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEXFLEX TOTAL HIP SYSTEM ALPHATEC/NEXMED 510(k) NO: K042252(SPECIAL) ATTN: ELLEN A YARNALL PHONE NO : 760-431-9286 6110 CORTE DEL CEDRO SE DECISION MADE: 06-DEC-04 CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II AMEDITECH, INC. 510(k) NO: K042975(TRADITIONAL) ATTN: JOHN WU PHONE NO : 858-535-1968 10340 CAMINO SANTA FE, SUITE F SE DECISION MADE: 29-DEC-04 SAN DIEGO, CA 92121 510(k) STATEMENT DEVICE: DREAM CLEANSE "S" SCALER, DREAM COMPACT "S" SCALER AMERICAN GREEN DENT. MFG, INC. 510(k) NO: K033044(TRADITIONAL) ATTN: ANDREW ROWE PHONE NO : 323-265-7000 3432 E. 14TH STREET SE DECISION MADE: 21-DEC-04 LOS ANGELES, CA 90023 510(k) STATEMENT DEVICE: INTEMESH SILICONE-COATED SLING AND SURGICAL MESH WITH INHIBIZONE AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K042592(TRADITIONAL) ATTN: KRISTYN BENSON PHONE NO : 952-930-6027 10700 BREN RD., WEST SE DECISION MADE: 14-DEC-04 MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANIMAS MODEL IR1250 INSULIN INFUSION PUMP ANIMAS CORP. 510(k) NO: K042873(TRADITIONAL) ATTN: THOMAS L PARKER PHONE NO : 484-568-1257 200 LAWRENCE DR. SE DECISION MADE: 10-DEC-04 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICRO-TOUCH SMOOTH NITRILE POWDER-FREE BLUE EXAMINATION GLOVES ( ANSELL HEALTHCARE PRODUCTS, INC. 510(k) NO: K042817(TRADITIONAL) ATTN: LON D MCLLVAIN PHONE NO : 334-615-2562 1635 INDUSTRIAL ROAD SE DECISION MADE: 06-DEC-04 DOTHAN, AL 36303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES ANTHOGYR 510(k) NO: K040671(TRADITIONAL) ATTN: ERIC GENEVE PHONE NO : 33 4 50580237 164 RUE DE TROIS LACS SE DECISION MADE: 14-DEC-04 SALLANCHES, FRANCE 74700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APEX K2 HIP SYSTEM APEX SURGICAL, LLC. 510(k) NO: K041950(TRADITIONAL) ATTN: EDWARD J CHEAL, PH.D PHONE NO : 508-947-6500 12 HARDING STREET,SUITE 202 SE DECISION MADE: 21-DEC-04 LAKEVILLE, MA 02347 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MISTAR, MODEL V3.2 APOLLO MEDICAL IMAGING TECHNOLOGY 510(k) NO: K043350(TRADITIONAL) ATTN: QING YANG PHONE NO : 03 985 99316 26 HOOD STREET NORTH SE DECISION MADE: 15-DEC-04 NORTH BALWYN 510(k) SUMMARY AVAILABLE FROM FDA MELBOURNE, VIC, AUSTRALIA 3104 THIRD PARTY REVIEW DEVICE: ACS MODEL NCP-2 APPLIED CARDIAC SYSTEMS 510(k) NO: K042413(TRADITIONAL) ATTN: R. BEN GHADIMI PHONE NO : 949-855-9366 22912 EL PACIFICO DR. SE DECISION MADE: 09-DEC-04 LAGUNA HILLS, CA 92653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20 APPLIED MEDICAL TECHNOLOGY, INC. 510(k) NO: K043027(SPECIAL) ATTN: DEREK WILLIAMS PHONE NO : 216-475-5577 15653 NEO PKWY. SE DECISION MADE: 02-DEC-04 CLEVELAND, OH 44128 510(k) STATEMENT DEVICE: PATHFINDER ARMSTRONG HEALTHCARE LIMITED 510(k) NO: K041477(TRADITIONAL) ATTN: PATRICK A FINLAY PHONE NO : 44 162 8536900 KNAVES BEECH BUSINESS CENTRE SE DECISION MADE: 09-DEC-04 LOUDWATER 510(k) SUMMARY AVAILABLE FROM FDA HIGH WYCOMBE, UNITED KINGDOM HP10 9QR DEVICE: ARTHREX SUTURE GRAFTING KIT ARTHREX, INC. 510(k) NO: K041553(TRADITIONAL) ATTN: ANN WATERHOUSE PHONE NO : 239-643-5553 1370 CREEKSIDE BLVD. SE DECISION MADE: 10-DEC-04 NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHREX BIO-CORKSCREW FT SUTURE ANCHOR ARTHREX, INC. 510(k) NO: K043337(SPECIAL) ATTN: SALLY FOUST PHONE NO : 239-643-5553 1370 CREEKSIDE BLVD. SE DECISION MADE: 14-DEC-04 NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARALLAX ACRYLIC RESIN WITH TRACERS, MODEL KP-PAR-003 ARTHROCARE CORP. 510(k) NO: K042947(TRADITIONAL) ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-735-6426 680 VAQUEROS AVE. SE DECISION MADE: 27-DEC-04 SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER ASTRA TECH, INC. 510(k) NO: K043241(SPECIAL) ATTN: BRUCE MANNING PHONE NO : 508-393-3100 20 MAIN STREET SE DECISION MADE: 23-DEC-04 NORTHBOROUGH, MA 01532 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXPRESS AND OASIS CHEST DRAIN ATRIUM MEDICAL CORP. 510(k) NO: K043140(SPECIAL) ATTN: JOSEPH P DE PAOLO PHONE NO : 603-880-1433 5 WENTWORTH DR. SE DECISION MADE: 08-DEC-04 HUDSON, NH 03051 510(k) STATEMENT DEVICE: RADIANCE PORCELAIN AURIDENT, INC. 510(k) NO: K042638(TRADITIONAL) ATTN: BRUCE D SPIVACK PHONE NO : 714-523-5544 610 S. STATE COLLEGE BLVD. SE DECISION MADE: 17-DEC-04 FULLERTON, CA 92831 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM BARCO NV BARCOVIEW 510(k) NO: K042221(TRADITIONAL) ATTN: FRANK FERGUSON PHONE NO : 505-332-8445 12200 ACADEMY ROAD NE SE DECISION MADE: 30-DEC-04 # 931 510(k) SUMMARY AVAILABLE FROM FDA ALBUQUERQUE, NM 87111 DEVICE: ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM BAYER HEALTHCARE, LLC 510(k) NO: K043158(TRADITIONAL) ATTN: GEORGE M TANCOS PHONE NO : 574-262-6928 1884 MILES AVE. SE DECISION MADE: 22-DEC-04 P.O. BOX 70 510(k) SUMMARY AVAILABLE FROM FDA ELKHART, IN 46515-2004 DEVICE: ASCENSIA ELITE DIABETES CARE SYSTEM BAYER HEALTHCARE, LLC 510(k) NO: K043311(SPECIAL) ATTN: GEORGE M TANCOS PHONE NO : 574-262-6928 1884 MILES AVE. SE DECISION MADE: 22-DEC-04 P.O. BOX 70 510(k) SUMMARY AVAILABLE FROM FDA ELKHART, IN 46514-0070 DEVICE: MODIFICATION TO BD ECLIPSE HYPODERMIC NEEDLE BECTON DICKINSON & CO. 510(k) NO: K043397(SPECIAL) ATTN: PASQUALE AMATO PHONE NO : 201-847-4513 1 BECTON DRIVE SE DECISION MADE: 29-DEC-04 FRANKLIN LAKES, NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD ONECATH BECTON DICKINSON INFUSION THERAPY 510(k) NO: K042862(TRADITIONAL) ATTN: LESLIE WOOD PHONE NO : 801-565-2504 9450 SOUTH STATE ST. SE DECISION MADE: 03-DEC-04 SANDY, UT 84070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM BECTON, DICKINSON & CO. 510(k) NO: K042932(TRADITIONAL) ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287 7 LOVETON CIR. SE DECISION MADE: 02-DEC-04 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOPLUS BERKELEY ADVANCED BIOMATERIALS, IN510(k) NO: K042636(SPECIAL) ATTN: FRANCOIS GENIN PHONE NO : 510-883-0500 1933 DAVIS ST. SUITE 307 SE DECISION MADE: 14-DEC-04 SAN LEANDRO, CA 94577 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BEST RADIOPAQUE STRAND; BEST RADIOPAQUE MARKER BEST MEDICAL INTERNATIONAL, INC. 510(k) NO: K043117(TRADITIONAL) ATTN: JOSEPH C WANG PHONE NO : 800-336-4970 7643 FULLERTON RD. SE DECISION MADE: 09-DEC-04 SPRINGFIELD, VA 22153 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTI BIO-RAD LABORATORIES, INC. 510(k) NO: K041658(TRADITIONAL) ATTN: CHRISTOPHER BENSTEN PHONE NO : 425-498-1709 6565 185TH AVE., N.E. SE DECISION MADE: 20-DEC-04 REDMOND, WA 98052 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL BIO-RAD LABORATORIES, INC. 510(k) NO: K043108(TRADITIONAL) ATTN: SUZANNE S PARSONS PHONE NO : 949-598-1467 9500 JERONIMO RD. SE DECISION MADE: 07-DEC-04 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOCARE SYSTEMS PREMIR 818 BIOCARE SYSTEMS, INC. 510(k) NO: K042532(TRADITIONAL) ATTN: CLAY ANSELMO PHONE NO : 303-223-4303 518 17TH STREET SE DECISION MADE: 13-DEC-04 SUITE 1350 510(k) SUMMARY AVAILABLE FROM FDA DENVER, CO 80202 DEVICE: BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116 BIOCHECK, INC. 510(k) NO: K041619(TRADITIONAL) ATTN: ROBIN J HELLEN, M.S. PHONE NO : 9418 LASAINE AVE. SE DECISION MADE: 17-DEC-04 NORTHRIDGE, CA 91325 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HELICOBACTER PYLORI IGG ELISA BIOHIT PLC 510(k) NO: K041238(TRADITIONAL) ATTN: ROBERT P GEARTY PHONE NO : 800 922 0784 3535 ROUTE 66 SE DECISION MADE: 13-DEC-04 BUILDING 4 510(k) SUMMARY AVAILABLE FROM FDA NEPTUNE, NJ 07753 DEVICE: VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR RIFAMPIN BIOMERIEUX, INC. 510(k) NO: K042946(TRADITIONAL) ATTN: JOLYN TENLLADO PHONE NO : 314-731-8386 595 ANGLUM RD. SE DECISION MADE: 07-DEC-04 HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR ERTAPENEM BIOMERIEUX, INC. 510(k) NO: K042963(TRADITIONAL) ATTN: JOLYN TENLLADO PHONE NO : 314-731-8386 595 ANGLUM RD. SE DECISION MADE: 13-DEC-04 HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR ERTAPENEM BIOMERIEUX, INC. 510(k) NO: K043230(TRADITIONAL) ATTN: JOLYN TENLLADO PHONE NO : 314-731-8386 595 ANGLUM RD. SE DECISION MADE: 30-DEC-04 HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR MOXIFLOXACIN BIOMERIEUX, INC. 510(k) NO: K043237(TRADITIONAL) ATTN: JOLYN TENLLADO PHONE NO : 314-731-8386 595 ANGLUM RD. SE DECISION MADE: 23-DEC-04 HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDALLION MODULAR HIP SYSTEM BIOMET MANUFACTURING, INC. 510(k) NO: K041850(TRADITIONAL) ATTN: LONNIE WITHAM PHONE NO : 574-372-1510 P.O. BOX 587 SE DECISION MADE: 21-DEC-04 WARSAW, IN 46581-0578 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODULAR ARTHRODESIS NAIL BIOMET, INC. 510(k) NO: K042409(TRADITIONAL) ATTN: GARY BAKER PHONE NO : 574-267-6639 56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 02-DEC-04 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIO-CORE INTERFERENCE SCREW BIOMET, INC. 510(k) NO: K042552(TRADITIONAL) ATTN: SUSAN ALEXANDER PHONE NO : 574-371-1152 56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 14-DEC-04 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: M2A/C2A ACETABULAR SYSTEM BIOMET, INC. 510(k) NO: K042841(TRADITIONAL) ATTN: PATRICIA S ANDBORN BERES PHONE NO : 574-267-6639 56 EAST BELL DR. SE DECISION MADE: 21-DEC-04 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46582 DEVICE: MIMIX MP BONE VOID FILLER BIOMET, INC. 510(k) NO: K043280(SPECIAL) ATTN: KACY ARNOLD PHONE NO : 574-267-6639 56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 21-DEC-04 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANEMIAPRO SELF-SCREENER BIOSAFE LABORATORIES, INC. 510(k) NO: K042379(TRADITIONAL) ATTN: JACK A MAGGIORE PHONE NO : 773-693-0400 100 FIELD DRIVE #240 SE DECISION MADE: 15-DEC-04 LAKE FOREST, IL 60045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300 BIOSITE INCORPORATED 510(k) NO: K042723(TRADITIONAL) ATTN: JERRREY R DAHLEN PHONE NO : 858-455-4808 11030 ROSELLE ST. SE DECISION MADE: 07-DEC-04 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET BIOTEQUE CORP. 510(k) NO: K033210(TRADITIONAL) ATTN: JENNIFER REICH PHONE NO : 928-773-9488 3892 SOUTH AMERICA WEST TRAIL SE DECISION MADE: 30-DEC-04 FLAGGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOTOP HOOKSAFE LUER-LOCK SAFETY SYRINGE, MODELS 3CC/ML, 5CC/ML BIOTOP TECHNOLOGY CO., LTD. 510(k) NO: K043038(SPECIAL) ATTN: MARK LIEN PHONE NO : 886 2 23957606 12 F-2, NO. 130 SE DECISION MADE: 22-DEC-04 CHUNG-HSIAO E.ROAD,SEC.2 510(k) SUMMARY AVAILABLE FROM FDA TAIPEI, CHINA (TAIWAN) 100 DEVICE: OUTPATIENT III MINOR SURGERY LIGHT BURTON MEDICAL PRODUCTS CORP. 510(k) NO: K042395(TRADITIONAL) ATTN: ASLE ASMUL PHONE NO : 818-701-8700 21100 LASSEN ST. SE DECISION MADE: 01-DEC-04 CHATSWORTH, CA 91311 510(k) STATEMENT DEVICE: ACUPUNCTURE NEEDLES C.A.I. INDUSTRIES CORP. 510(k) NO: K041652(TRADITIONAL) ATTN: LU RAO PHONE NO : 626-448-6622 10166 RUSH ST. SE DECISION MADE: 29-DEC-04 SOUTH EL MONTE, CA 91007 510(k) STATEMENT DEVICE: BARD INLAYOPTIMA URETERAL STENT WITH SUTURE C.R. BARD, INC. 510(k) NO: K043193(SPECIAL) ATTN: FRANCES E HARRISON PHONE NO : 770-784-6257 8195 INDUSTRIAL BLVD SE DECISION MADE: 07-DEC-04 COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUID STABLE HBA1C CONTROL CANTERBURY SCIENTIFIC LTD. 510(k) NO: K043070(TRADITIONAL) ATTN: MAURICE OWEN PHONE NO : 643 343 3345 14 POPE STREET SE DECISION MADE: 09-DEC-04 CHRISTCHURCH, CANTERBURY, NEW ZEAL510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PMP4 OXY PRO CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K043162(TRADITIONAL) ATTN: BORIS ARADOVSKY PHONE NO : 972 894 84000 2 PEKERIS ST. SE DECISION MADE: 29-DEC-04 PO BOX 527 510(k) SUMMARY AVAILABLE FROM FDA REHOVOT, ISRAEL 76100 DEVICE: ESTEEM BLUE POLYISOPRENE SURGICAL GLOVES WITH COATING (CONTAININ CARDINAL HEALTH 510(k) NO: K042574(TRADITIONAL) ATTN: ERICA SETHI PHONE NO : 847-785-3337 1500 WAUKEGAN RD. SE DECISION MADE: 08-DEC-04 MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: BIOZDX HEMODYNAMIC MONITOR CARDIODYNAMICS INTERNATIONAL CORP.510(k) NO: K041294(TRADITIONAL) ATTN: DENNIS HEPP PHONE NO : 858-535-0202 6175 NANCY RIDGE DR., #300 SE DECISION MADE: 08-DEC-04 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERASYS - ZR CERASYS, INC. 510(k) NO: K042548(TRADITIONAL) ATTN: JIN KIM PHONE NO : 562-942-9700 11761 TELEGRAPH ROAD SE DECISION MADE: 03-DEC-04 SANTA FE SPRINGS, CA 90670 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER CHURCHILL MEDICAL SYSTEMS, INC. 510(k) NO: K041038(ABBREVIATED) ATTN: KEITH PALUCH PHONE NO : 603-743-5988 87 VENTURE DR. SE DECISION MADE: 21-DEC-04 ENTERPRISE PARK 510(k) SUMMARY AVAILABLE FROM FDA DOVER, NH 03820 DEVICE: DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE COLLAGEN MATRIX, INC. 510(k) NO: K040888(TRADITIONAL) ATTN: PEGGY HANSEN PHONE NO : 201-405-1477 509 COMMERCE ST. SE DECISION MADE: 01-DEC-04 FRANKLIN LAKES,, NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005093 CONFLUENT SURGICAL,INC 510(k) NO: K042588(TRADITIONAL) ATTN: ERIC ANKERUD PHONE NO : 781-693-2333 101A FIRST AVE. SE DECISION MADE: 09-DEC-04 WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONSOLIDATED SR AND SSE MC-SERIES STEAM STERILIZER CONSOLIDATED MACHINE CORP. 510(k) NO: K041833(ABBREVIATED) ATTN: ARTHUR TRAPOTSIS PHONE NO : 617-783-2607 76 ASHFORD ST. SE DECISION MADE: 10-DEC-04 BOSTON, MA 02134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: ZILVER 635 BILIARY STENT COOK, INC. 510(k) NO: K043481(SPECIAL) ATTN: LELAND KEYT PHONE NO : 800-346-2686 750 DANIELS WAY PO BX 489 SE DECISION MADE: 29-DEC-04 BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEM COPAN DIAGNOSTICS, INC. 510(k) NO: K042970(TRADITIONAL) ATTN: CYNTHIA SINCLAIR PHONE NO : 508-643-0434 49 PLAIN ST. SE DECISION MADE: 07-DEC-04 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE CORDIS CORP. 510(k) NO: K040592(TRADITIONAL) ATTN: DAVID KORNHAUSER PHONE NO : 786-313-8704 14201 N.W. 60TH AVE. SE DECISION MADE: 17-DEC-04 MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COSMEDENT PIT & FISSURE SEALANT COSMEDENT, INC. 510(k) NO: K042823(TRADITIONAL) ATTN: JAMES L SANDRIK PHONE NO : 312-644-9586 401 NORTH MICHIGAN AVE. SE DECISION MADE: 01-DEC-04 SUITE 2500 510(k) SUMMARY AVAILABLE FROM FDA CHICAGO, IL 60611 DEVICE: CLINICAL ELECTRONIC THERMOMETER COTRONIC MANUFACTURING 510(k) NO: K032434(TRADITIONAL) ATTN: SHINE WAN PHONE NO : 86 755 27477681 JIU WEI, XI XIANG SE DECISION MADE: 27-DEC-04 BAO AN ZONE 510(k) SUMMARY AVAILABLE FROM FDA SHEN ZHEN, CHINA DEVICE: DOC BAND-POSTOP CRANIAL TECHNOLOGIES, INC. 510(k) NO: K042385(TRADITIONAL) ATTN: TIMOTHY R LITTLEFIELD PHONE NO : 480-505-1840 1395 WEST AUTO DR. SE DECISION MADE: 17-DEC-04 TEMPE, AZ 85284 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WHEELCHAIR, MODEL 8500-II CYCLING AND HEALTH TECH. INDUSTRY 510(k) NO: K043332(TRADITIONAL) ATTN: ZEN-JYE CHEN PHONE NO : 886 4 22842291 111-X60, LANE 68 SE DECISION MADE: 13-DEC-04 FU-HSING N. RD. 510(k) SUMMARY AVAILABLE FROM FDA TAICHUNG, CHINA (TAIWAN) 407 DEVICE: CONTROL PLASMA N, PROC CONTROL PLASMA DADE BEHRING, INC. 510(k) NO: K042333(TRADITIONAL) ATTN: RADAMES RIESGO PHONE NO : 305-480-7558 500 GBC DR. SE DECISION MADE: 01-DEC-04 NEWARK, DE 19702 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENZYGNOST F+2 (MONOCLONAL) TEST KIT DADE BEHRING, INC. 510(k) NO: K042687(TRADITIONAL) ATTN: DONNA WOLF PHONE NO : 302-631-0384 P.O. BOX 6101 SE DECISION MADE: 10-DEC-04 NEWARK,, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS DADE BEHRING, INC. 510(k) NO: K042941(TRADITIONAL) ATTN: RADAMES RIESGO PHONE NO : 305-480-7558 GLASCO B500 M.S. 514 SE DECISION MADE: 02-DEC-04 P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: DATEX-OHMEDA S/5TM FM WITH L-FICU04 AND L-FICU04A SOFTWARE AND N DATEX-OHMEDA 510(k) NO: K043276(TRADITIONAL) ATTN: JOEL KENT PHONE NO : 781-449-8685 86 PILGRIM RD. SE DECISION MADE: 23-DEC-04 NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TUF LINK SILICONE RELINER DENTATUS USA, LTD. 510(k) NO: K042931(TRADITIONAL) ATTN: THOMAS MURPHY PHONE NO : 212-481-1010 192 LEXINGTON AVE. SE DECISION MADE: 08-DEC-04 NEW YORK, NY 10016 510(k) STATEMENT DEVICE: DUCERA ALLCERAM DENTSPLY INTL. 510(k) NO: K043247(TRADITIONAL) ATTN: HELEN LEWIS PHONE NO : 717-845-7511 221 WEST PHILADELPHIA STREET SE DECISION MADE: 22-DEC-04 SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA YORK, PA 17404 DEVICE: BLUE ORTHOCORD SUTURE DEPUY MITEK 510(k) NO: K043298(SPECIAL) ATTN: RUTH C FORSTADT PHONE NO : 781-251-3188 249 VANDERBILT DR. SE DECISION MADE: 10-DEC-04 NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEPUY C-STEM AMT HIP PROSTHESIS DEPUY ORTHOPAEDICS, INC. 510(k) NO: K042959(SPECIAL) ATTN: DINA L WEISSMAN PHONE NO : 574-371-4905 700 ORTHOPAEDIC DR. SE DECISION MADE: 22-DEC-04 P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0988 DEVICE: LPS UPPER EXTREMITY DEPUY, INC. 510(k) NO: K042664(TRADITIONAL) ATTN: TIFFANI D ROGERS PHONE NO : 574-371-4927 P.O. BOX 988 SE DECISION MADE: 08-DEC-04 700 ORTHOPAEDIC DRIVE 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0988 DEVICE: SALICYLATE-SL ASSAY DIAGNOSTIC CHEMICALS LTD. 510(k) NO: K042329(TRADITIONAL) ATTN: NANCY OLSCAMP PHONE NO : 800 565 0265 16 MCCARVILLE ST. SE DECISION MADE: 27-DEC-04 WEST ROYALTY INDUSTRIAL PARK 510(k) STATEMENT CHARLOTTETOWN, PRINCE EDWARD, CANADA C1E 2A6 DEVICE: MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299- DIAGNOSTIC CHEMICALS LTD. 510(k) NO: K042362(TRADITIONAL) ATTN: NANCY OLSCAMP PHONE NO : 902 566 1396 16 MCCARVILLE ST. SE DECISION MADE: 27-DEC-04 CHARLOTTETOWN, CANADA C1E 2A6 510(k) STATEMENT DEVICE: EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS DIOMED, INC. 510(k) NO: K041957(TRADITIONAL) ATTN: MAUREEN O'CONNELL PHONE NO : 978-207-1245 5 TIMBER LANE SE DECISION MADE: 01-DEC-04 NORTH READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO D-TRONPLUS DISETRONIC MEDICAL SYSTEMS AG 510(k) NO: K043000(SPECIAL) ATTN: SCOTT THIEL PHONE NO : 317-521-3362 9115 HAGUE ROAD SE DECISION MADE: 01-DEC-04 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DRAGON HEART PISTON SYRINGE DRAGON HEART MEDICAL DEVICES CO., 510(k) NO: K042547(ABBREVIATED) ATTN: JINA YU PHONE NO : 630-833-6998 188 INDUSTRIAL DRIVE SE DECISION MADE: 01-DEC-04 SUITE 108 510(k) STATEMENT ELMHURST, IL 60126 DEVICE: DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR K DREW SCIENTIFIC LTD. 510(k) NO: K043378(ABBREVIATED) ATTN: DIANE HILL PHONE NO : 441 229 432089 SOWERBY WOODS BUSINESS PARK SE DECISION MADE: 29-DEC-04 PARK ROAD 510(k) STATEMENT BARROW IN FURNESS CUMBRIA, UNITED KINGDOM LA14 4QR DEVICE: CAPSULE TENSION RING INSERTER, MODEL 7-810 DUCKWORTH & KENT, LTD. 510(k) NO: K042478(TRADITIONAL) ATTN: MARTIN LOCK PHONE NO : 441 462 893254 TERENCE HOUSE, 7 MARQUIS SE DECISION MADE: 28-DEC-04 BUSINESS CENTRE ROYSTON RD. 510(k) STATEMENT BALDOCK, HERTS, UNITED KINGDOM SG7 6XL DEVICE: PANALIGHT-BLU, MODEL 4175 DUSA PHARMACEUTICALS, INC. 510(k) NO: K043164(TRADITIONAL) ATTN: SCOTT LUNDAHL PHONE NO : 978-657-7500 25 UPTON DR. SE DECISION MADE: 10-DEC-04 WILMINGTON, MA 01887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EBI ARRAY SPINAL FIXATION SYSTEM AND SPINELINK II SPINAL FIXATIO EBI, L.P. 510(k) NO: K042772(TRADITIONAL) ATTN: FREDERIC TESTA PHONE NO : 973-299-9300 100 INTERPACE PKWY. SE DECISION MADE: 13-DEC-04 PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFESTENT NT35 BILIARY STENT SYSTEM EDWARDS LIFESCIENCES, LLC. 510(k) NO: K042985(SPECIAL) ATTN: KEVIN DRISKO PHONE NO : 949-250-2416 ONE EDWARDS WAY SE DECISION MADE: 23-DEC-04 IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIGILANCE II CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VOLUMETRIC MONIT EDWARDS LIFESCIENCES, LLC. 510(k) NO: K043103(SPECIAL) ATTN: PAULA A TORRIANNI PHONE NO : 714-250-2418 ONE EDWARDS WAY SE DECISION MADE: 09-DEC-04 IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO LYSUS INFUSION SYSTEM EKOS CORP. 510(k) NO: K043269(SPECIAL) ATTN: JOCELYN KERSTEN PHONE NO : 425-482-1108 22030 20TH AVENUE S.E. SE DECISION MADE: 22-DEC-04 SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA BOTHELL, WA 98021 DEVICE: DIFOTI USB 2.0 SYSTEM ELECTRO-OPTICAL SCIENCES, INC. 510(k) NO: K043068(TRADITIONAL) ATTN: MICHAEL GREENEBAUM PHONE NO : 914-591-3783 1 BRIDGE ST. SUITE 15 SE DECISION MADE: 29-DEC-04 IRVINGTON-ON HUDSON, NY 10533 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXI-STAT SP02 EAR SENSOR ELEKON INDUSTRIES U.S.A., INC. 510(k) NO: K042675(TRADITIONAL) ATTN: KRISTA OAKES PHONE NO : 972-849-5167 2300 MCDERMOTT RD. SE DECISION MADE: 06-DEC-04 #200-207 510(k) SUMMARY AVAILABLE FROM FDA PLANO, TX 75025 DEVICE: DISPOSABLE NON-ADHESIVE SPO2 SENSORS ELEKON INDUSTRIES U.S.A., INC. 510(k) NO: K042705(TRADITIONAL) ATTN: KRISTA OAKES PHONE NO : 972-849-5167 2300 MCDERMOTT RD. SE DECISION MADE: 29-DEC-04 #200-207 510(k) SUMMARY AVAILABLE FROM FDA PLANO, TX 75025 DEVICE: EMG MODEL SUA01 SUCTION UNIT EMG TECHNOLOGY CO., LTD. 510(k) NO: K042349(ABBREVIATED) ATTN: LEONARD FRIER PHONE NO : 410-354-3300 914 WEST PATAPSCO AVE. SE DECISION MADE: 16-DEC-04 BALTIMORE, MD 21230 510(k) STATEMENT DEVICE: INFINITY ELECTROTHERAPY SYSTEM EMPI 510(k) NO: K042057(TRADITIONAL) ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434 49 PLAIN ST. SE DECISION MADE: 17-DEC-04 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HARMONIC ACE CURVED SHEARS WITH HAND CONTROL, MODEL ACE23P, ACE3 ETHICON ENDO-SURGERY, INC. 510(k) NO: K042777(TRADITIONAL) ATTN: KIMBERLY SHOEMAKER PHONE NO : 513-337-8123 4545 CREEK RD. SE DECISION MADE: 01-DEC-04 CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GYNECARE PROLENE FASTENER SYSTEM ETHICON, INC. 510(k) NO: K042603(TRADITIONAL) ATTN: SEAN O'BRYAN PHONE NO : 908-218-2456 ROUTE 22 WEST SE DECISION MADE: 22-DEC-04 SOMERVILLE, NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRIMUS STENT AND DELIVERY SYSTEM EV3 INC 510(k) NO: K043243(SPECIAL) ATTN: GLEN D SMYTHE PHONE NO : 763-398-7391 4600 NATHAN LN. NORTH SE DECISION MADE: 09-DEC-04 PLYMOUTH, MN 55442 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CEMEX SYSTEM GENTA FAST BONE CEMENT EXACTECH, INC. 510(k) NO: K043403(SPECIAL) ATTN: LISA SIMPSON PHONE NO : 352-377-1140 2320 N.W. 66TH CT. SE DECISION MADE: 28-DEC-04 GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FEMSPEC DISPOSABLE VAGINAL SPECULUM FEMSPEC L.L.C. 510(k) NO: K041757(TRADITIONAL) ATTN: GERALD JAY SANDERS PHONE NO : 415-561-2565 220 HALLECK STREET, SUITE 120 SE DECISION MADE: 23-DEC-04 P.O. BOX 29450 510(k) SUMMARY AVAILABLE FROM FDA SAN FRANCISCO, CA 94129-0450 DEVICE: FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K043244(SPECIAL) ATTN: ARTHUR EILINSFELD PHONE NO : 781-402-9068 95 HAYDEN AVE. SE DECISION MADE: 20-DEC-04 LEXINGTON, MA 02420-9192 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARCHITECT CA 15-3 ASSAY FUJIREBIO DIAGNOSTICS, INC. 510(k) NO: K042732(TRADITIONAL) ATTN: KIMBERLY PETERSON PHONE NO : 610-240-3828 201 GREAT VALLEY PKWY. SE DECISION MADE: 22-DEC-04 MALVERN, PA 19355-1307 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEART RATE TURBULENCE ANALYSIS TECHNOLOGIES GE MEDICAL SYST. INFORMATION TECHN510(k) NO: K042148(TRADITIONAL) ATTN: LISA M BAUMHARDT PHONE NO : 262-293-1699 8200 WEST TOWER AVE. SE DECISION MADE: 03-DEC-04 MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFINIA LIGHTSPEED GE MEDICAL SYSTEMS F.I. HAIFA 510(k) NO: K043381(TRADITIONAL) ATTN: LAURENCE BIGIO PHONE NO : 972 4 8563633 4 HAYOZMA ST. SE DECISION MADE: 23-DEC-04 TIRAT HACARMEL, ISRAEL 30200 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: GE OEC FLUOROSTAR GE OEC MEDICAL SYSTEMS, INC. 510(k) NO: K043076(TRADITIONAL) ATTN: JEFF WAGNER PHONE NO : 801-536-4668 384 WRIGHT BROTHERS DR. SE DECISION MADE: 22-DEC-04 SALT LAKE CITY, UT 84116 510(k) STATEMENT DEVICE: GENCHEM ISE ELECTROLYTE REFERENCE GENCHEM, INC. 510(k) NO: K040971(TRADITIONAL) ATTN: C.C. ALLAIN PHONE NO : 714-529-7125 471 W. LAMBERT RD., SUITE 107 SE DECISION MADE: 22-DEC-04 BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CALCIUM, AZO DYE REAGENT GENCHEM, INC. 510(k) NO: K040972(TRADITIONAL) ATTN: C.C. ALLAIN PHONE NO : 714-529-7125 471 W. LAMBERT RD., SUITE 107 SE DECISION MADE: 27-DEC-04 BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BUN REAGENT GENCHEM, INC. 510(k) NO: K040973(TRADITIONAL) ATTN: C.C. ALLAIN PHONE NO : 714-529-7125 471 W. LAMBERT RD., SUITE 107 SE DECISION MADE: 27-DEC-04 BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLUCOSE OXIDASE, GLUCOSE GENCHEM, INC. 510(k) NO: K040974(TRADITIONAL) ATTN: C.C. ALLAIN PHONE NO : 714-529-7125 471 W. LAMBERT RD., SUITE 107 SE DECISION MADE: 27-DEC-04 BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENCHEM CO2 ACID REAGENT GENCHEM, INC. 510(k) NO: K040975(TRADITIONAL) ATTN: C.C. ALLAIN PHONE NO : 714-529-7125 471 W. LAMBERT RD., SUITE 107 SE DECISION MADE: 27-DEC-04 BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENCHEM CREATININE REAGENT GENCHEM, INC. 510(k) NO: K040976(TRADITIONAL) ATTN: C.C. ALLAIN PHONE NO : 714-529-7125 471 W. LAMBERT RD., SUITE 107 SE DECISION MADE: 27-DEC-04 BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENCHEM ELECTROLYTE BUFFER GENCHEM, INC. 510(k) NO: K040977(TRADITIONAL) ATTN: C.C. ALLAIN PHONE NO : 714-529-7125 471 W. LAMBERT RD., SUITE 107 SE DECISION MADE: 27-DEC-04 BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENESTONE EXEL (XL) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER GENEMED, INC. 510(k) NO: K042427(SPECIAL) ATTN: DAVID BALZER PHONE NO : 203-263-5951 660 MAIN STREET SOUTH SE DECISION MADE: 03-DEC-04 SUITE 7 510(k) STATEMENT WOODBURY, CT 06798 DEVICE: GERBER DOUBLE ELECTRIC BREAST PUMP GERBER PRODUCTS CO. 510(k) NO: K043098(TRADITIONAL) ATTN: RANGA RANGANATHAN PHONE NO : 231-928-2831 445 STATE ST. SE DECISION MADE: 15-DEC-04 FREMONT, MI 49413 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: STERICHEK BLOOD LEAK REAGENT STRIPS HACH COMPANY 510(k) NO: K042322(TRADITIONAL) ATTN: DAVID A MORRIS, PH.D. PHONE NO : 219-262-2060 23575 COUNTY ROAD 106 SE DECISION MADE: 07-DEC-04 ELKHART, IN 46514 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORRECT DENTAL IMPRESSION MATERIAL HANDAE CHEMICAL CO., LTD. 510(k) NO: K042860(TRADITIONAL) ATTN: JAE HO YU PHONE NO : 824 353 42191 560-24, SONGDU-RI, JINCHEON-UP SE DECISION MADE: 03-DEC-04 JINCHEON-GUN,CHUNGCHEONGBUK-DO, RE510(k) STATEMENT365-802 DEVICE: WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), HANGZHOU HUA'AN MEDICAL & HEALTH I510(k) NO: K041693(TRADITIONAL) ATTN: JI BO PHONE NO : 86 571 88734065 BUILDING 2, BAIMIAO INDU. PARK SE DECISION MADE: 02-DEC-04 ECONOMIC DEVELOP. ZONE WUCHANG 510(k) STATEMENT HANGZHOU, ZHEJIANG, CHINA 310023 DEVICE: H & L (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888EM HEALTH & LIFE CO., LTD. 510(k) NO: K043186(SPECIAL) ATTN: PAUL HUNG PHONE NO : 886 2 82271300 9F, NO.186, JIAN YI ROAD SE DECISION MADE: 06-DEC-04 CHUNG HO CITY, TAIPEI, CHINA (TAIW510(k) STATEMENT DEVICE: OSTIM HERAEUS KULZER, INC. 510(k) NO: K030052(TRADITIONAL) ATTN: CHERYL V ZIMMERMAN PHONE NO : 219-299-6662 4315 SOUTH LAFAYETTE BLVD. SE DECISION MADE: 06-DEC-04 SOUTH BEND, IN 46614-2517 510(k) STATEMENT DEVICE: FLEXITIME XTREME HERAEUS KULZER, INC. 510(k) NO: K042878(TRADITIONAL) ATTN: CHERYL V ZIMMERMAN PHONE NO : 574-299-6662 4315 SOUTH LAFAYETTE BLVD. SE DECISION MADE: 17-DEC-04 SOUTH BEND, IN 46614-2517 510(k) STATEMENT DEVICE: HEALTHSTAR ELITE HILL LABORATORIES CO. 510(k) NO: K043239(TRADITIONAL) ATTN: HOWARD A HILL PHONE NO : 610-644-2867 3 BACTON HILL RD. SE DECISION MADE: 22-DEC-04 P.O. BOX 2028 510(k) SUMMARY AVAILABLE FROM FDA FRAZER, PA 19355 THIRD PARTY REVIEW DEVICE: HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PC HOSPIRA, INC. 510(k) NO: K043256(SPECIAL) ATTN: PATRICIA MELERSKI PHONE NO : 224-212-4880 275 N. FIELD DR., BLDG. H-2 SE DECISION MADE: 06-DEC-04 D-389 510(k) SUMMARY AVAILABLE FROM FDA LAKE FOREST, IL 60045-5045 DEVICE: HOVEROUND SE-3 POWERCHAIR HOVEROUND CORP. 510(k) NO: K042920(TRADITIONAL) ATTN: TONY DIGIOVANNI PHONE NO : 941-739-6200 2151 WHITFIELD INDUSTRIAL WAY SE DECISION MADE: 03-DEC-04 SARASOTA, FL 34243 510(k) STATEMENT DEVICE: HOVEROUND E100 POWER CHAIR HOVEROUND CORP. 510(k) NO: K043069(TRADITIONAL) ATTN: TONY DIGIOVANNI PHONE NO : 941-739-6200 2151 WHITFIELD INDUSTRIAL WAY SE DECISION MADE: 03-DEC-04 SARASOTA, FL 34243 510(k) STATEMENT DEVICE: MODIFICATION TO T2 PROXIMAL HUMERAL NAIL HOWMEDICA OSTEONICS CORP. 510(k) NO: K043404(SPECIAL) ATTN: VIVIAN KELLY PHONE NO : 201-831-5581 325 CORPORATE DRIVE SE DECISION MADE: 27-DEC-04 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGPLAN AND PANPLAN IMAGING SCIENCES INTL., INC. 510(k) NO: K041078(TRADITIONAL) ATTN: EDWARD J MARANDOLA PHONE NO : 215-997-5666 1910 NORTH PENN RD. SE DECISION MADE: 23-DEC-04 HATFIELD, PA 19440 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GAMMA-B 1,25-DIHYDROXY VITAMIN D IMMUNODIAGNOSTIC SYSTEMS LTD. 510(k) NO: K042519(ABBREVIATED) ATTN: PAUL PUNTIN PHONE NO : 440 191 5190660 10 DIDCOT WAY, SE DECISION MADE: 01-DEC-04 BOLDEN BUSINESS PARK 510(k) STATEMENT BOLDON, TYNE & WEAR, UNITED KINGDOM NE35 9PD DEVICE: MODIFICATION TO: VIEWSTATION IMPAC MEDICAL SYSTEMS, INC. 510(k) NO: K043412(SPECIAL) ATTN: THOMAS H FARIS PHONE NO : 650-623-8807 100 WEST EVELYN AVE. SE DECISION MADE: 20-DEC-04 MOUNTAIN VIEW, CA 94041-1464 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRABECULAR METAL KNEE SYSTEM AUGMENTS IMPLEX CORP. 510(k) NO: K040487(TRADITIONAL) ATTN: MARCI HALEVI PHONE NO : 201-818-1800 80 COMMERCE DR. SE DECISION MADE: 21-DEC-04 ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 12-LEAD GLOVE INEEDMD 510(k) NO: K033559(TRADITIONAL) ATTN: IRVING WIESEN, ESQ. PHONE NO : 203-327-1372 860 CANAL STREET SE DECISION MADE: 22-DEC-04 STAMFORD, CT 06902 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IR VIEWER INFRARED IMAGING SYSTEMS, INC. 510(k) NO: K042679(TRADITIONAL) ATTN: DALE SIEGEL PHONE NO : 614-675-3729 1275 KINNEAR ROAD SE DECISION MADE: 10-DEC-04 COLUMBUS, OH 43212 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCALLOPED ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM INNOVA LIFE SCIENCES CORP. 510(k) NO: K043190(SPECIAL) ATTN: HOWARD HOLSTEIN PHONE NO : 202-637-5813 555 13TH ST. N.W. SE DECISION MADE: 14-DEC-04 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EAR THERMOMETER, MODEL WL-320X INNOVATECH, INC 510(k) NO: K042631(TRADITIONAL) ATTN: TONY C CHANG PHONE NO : 886 422 972787 NO 5, ALLEY 5, SE DECISION MADE: 22-DEC-04 LANE CHENG HSING, CHUNG CHING 510(k) STATEMENT PEI TUN DIST. TAICHUNG, CHINA (TAIWAN) DEVICE: COATEST SP FVIII INSTRUMENTATION LABORATORY CO. 510(k) NO: K042576(TRADITIONAL) ATTN: CAROL MARBLE PHONE NO : 781-861-4467 113 HARTWELL AVE. SE DECISION MADE: 02-DEC-04 LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUANTEX MYOGLOBIN INSTRUMENTATION LABORATORY CO. 510(k) NO: K042982(TRADITIONAL) ATTN: CAROL MARBLE PHONE NO : 781-861-4467 113 HARTWELL AVE. SE DECISION MADE: 22-DEC-04 LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMOSIL RECOMBIPLASTIN INSTRUMENTATION LABORATORY CO. 510(k) NO: K043184(SPECIAL) ATTN: CAROL MARBLE PHONE NO : 781-861-4467 113 HARTWELL AVE. SE DECISION MADE: 22-DEC-04 LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM INTEGRA LIFESCIENCES CORPORATION 510(k) NO: K042825(TRADITIONAL) ATTN: DARLENE M WALSH PHONE NO : 609-275-0050 311 ENTERPRISE DR. SE DECISION MADE: 21-DEC-04 PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TITANIUM MESH IMPLANT INTERPORE CROSS INTL. 510(k) NO: K041407(TRADITIONAL) ATTN: WENDY SPIELBERGER PHONE NO : 949-453-3200 181 TECHNOLOGY DR. SE DECISION MADE: 29-DEC-04 IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO ALTIUS OCT SYSTEM INTERPORE CROSS INTL. 510(k) NO: K043229(SPECIAL) ATTN: WENDY SPIELBERGER PHONE NO : 949-453-3200 181 TECHNOLOGY DR. SE DECISION MADE: 21-DEC-04 IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTR INTUITIVE SURGICAL, INC. 510(k) NO: K043153(SPECIAL) ATTN: MICHAEL H YRAMATEGUI PHONE NO : 408-523-2100 950 KIFER RD. SE DECISION MADE: 15-DEC-04 SUNNYVALE, CA 94086-5206 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WATCH PAT 100S ITAMAR MEDICAL LTD. 510(k) NO: K042916(TRADITIONAL) ATTN: JONATHAN S KAHN PHONE NO : 202-637-5794 555 THIRTEENTH STREET, NW SE DECISION MADE: 29-DEC-04 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYSTEMP.C&B PLUS IVOCLAR VIVADENT, INC. 510(k) NO: K042820(TRADITIONAL) ATTN: DONNA HARTNETT PHONE NO : 716-691-2260 175 PINEVIEW DR. SE DECISION MADE: 14-DEC-04 AMHERST, NY 14228 510(k) STATEMENT DEVICE: SYSTEMP.LINK IVOCLAR VIVADENT, INC. 510(k) NO: K042846(TRADITIONAL) ATTN: DONNA M HARTNETT PHONE NO : 716-691-0010 175 PINEVIEW DR. SE DECISION MADE: 20-DEC-04 AMHERST, NY 14228 510(k) STATEMENT DEVICE: SYSTEMP.CEM IVOCLAR VIVADENT, INC. 510(k) NO: K042847(TRADITIONAL) ATTN: DONNA M HARTNETT PHONE NO : 716-691-2260 175 PINEVIEW DR. SE DECISION MADE: 17-DEC-04 AMHERST, NY 14228 510(k) STATEMENT DEVICE: WILLI GELLER CREATION CP PORCELAIN JENSEN INDUSTRIES, INC. 510(k) NO: K043221(TRADITIONAL) ATTN: GARY PHELPS PHONE NO : 203-239-2090 50 STILLMAN RD. SE DECISION MADE: 20-DEC-04 NORTH HAVEN, CT 06473 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KA KAMIYA BIOMEDICAL CO. 510(k) NO: K042241(TRADITIONAL) ATTN: BRIAN SCHLIESMAN PHONE NO : 206-575-8068 12779 GATEWAY DR. SE DECISION MADE: 10-DEC-04 SEATTLE, WA 98168 510(k) STATEMENT DEVICE: KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MODEL KENDALL 510(k) NO: K042461(ABBREVIATED) ATTN: PAUL W EVANS PHONE NO : 508-261-8203 15 HAMPSHIRE ST. SE DECISION MADE: 10-DEC-04 MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER WITH SLOTTED SY KENDALL 510(k) NO: K043272(SPECIAL) ATTN: JIM WELSH PHONE NO : 508-261-8532 15 HAMPSHIRE ST. SE DECISION MADE: 22-DEC-04 MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KIMBERLY-CLARK MIC-KEY LOW PROFILE GASTROSTOMY TUBE KIMBERLY-CLARK CORP. 510(k) NO: K043114(SPECIAL) ATTN: S. MCMILLAN PHONE NO : 801-523-5295 12050 LONE PEAK PARKWAY SE DECISION MADE: 10-DEC-04 DRAPER, UT 84020 510(k) STATEMENT DEVICE: DIRECT DIGITIZER, REGIUS MODEL 190 KONICA MINOLTA MEDICAL & GRAPHIC, 510(k) NO: K042386(SPECIAL) ATTN: SHINICHI YAMANAKA PHONE NO : 81 596 370190 PROGRESS SECTION SE DECISION MADE: 15-DEC-04 319 AKENO, OBATA-CHO 510(k) SUMMARY AVAILABLE FROM FDA WATARAI-GUN; MIE-KEN, JAPAN 519-05 DEVICE: KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KI KRONUS MARKET DEVELOPMENT ASSOCIAT510(k) NO: K042248(TRADITIONAL) ATTN: HEATHER VIELE PHONE NO : 208-377-4800 12554 WEST BRIDGER ST. SE DECISION MADE: 17-DEC-04 SUITE 108 510(k) STATEMENT BOISE, ID 83713 DEVICE: CLEAFIL DC CORE AUTOMIX KURARAY MEDICAL INC. 510(k) NO: K043177(TRADITIONAL) ATTN: SATOSHI YAMAGUCHI PHONE NO : 212-986-2230 101 EAST 52ND STREET, 26TH FL. SE DECISION MADE: 17-DEC-04 NEW YORK, NY 10022 510(k) STATEMENT DEVICE: ESTENIA C&B KURARAY MEDICAL KURASHIKI PLANT 510(k) NO: K042929(TRADITIONAL) ATTN: KOJI NISHIDA PHONE NO : 212-986-2230 101 EAST 52ND STREET SE DECISION MADE: 06-DEC-04 26TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA NEW YORK, NY 10022 DEVICE: PRUITT-INAHARA OUTLYING CAROTID SHUNT, MODELS, 2012-49, 2013-49, LEMAITRE VASCULAR, INC. 510(k) NO: K043023(SPECIAL) ATTN: SABA MODJARRAD PHONE NO : 781-221-2266 63 2ND AVENUE SE DECISION MADE: 03-DEC-04 BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENTLEWAVES LED PHOTOMODULATION DEVICE LIGHT BIOSCIENCE, LLC 510(k) NO: K031425(TRADITIONAL) ATTN: ROBERT T HANDREN, JR. PHONE NO : 352-314-8829 5818 PRIONCESS CAROLINE PLACE SE DECISION MADE: 15-DEC-04 LEESBURG, FL 34748 510(k) STATEMENT DEVICE: OPUSDUO; OPUSDUO E; OPUSDUO EC; OPUS 20; OPUS SPECTRUM LUMENIS LTD. 510(k) NO: K040270(TRADITIONAL) ATTN: ANDREA L RUTH PHONE NO : 408-764-3235 2400 CONDENSA STREET SE DECISION MADE: 16-DEC-04 SANTA CLARA, CA 95051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUTH-ALL SUB-Q NEEDLE SET LUTH-ALL MEDICAL PRODUCTS, LLC 510(k) NO: K042666(TRADITIONAL) ATTN: SHEPARD G BENTLEY PHONE NO : 949-365-5790 28303 CABOT RD. SUITE 300 SE DECISION MADE: 21-DEC-04 LAGUNA NIGUEL, CA 92677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITAL VISION ARTERIAL HARDNESS AND BLOOD PRESSURE MONITOR MARS MEDICAL PRODUCTS CO., LTD. 510(k) NO: K032825(TRADITIONAL) ATTN: E.J. SMITH PHONE NO : 410-451-0639 P.O. BOX 4341 SE DECISION MADE: 10-DEC-04 CROFTON, MD 21114-4341 510(k) STATEMENT DEVICE: UNIVERSAL XACTTRACE MEDCARE FLAGA 510(k) NO: K043132(TRADITIONAL) ATTN: KOLBRUN E OTTOSDOTTIR PHONE NO : 011 354 5102000 SIDUMULI 24 SE DECISION MADE: 21-DEC-04 REYKJAVIK, ICELAND IS 108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASCULAR TOOLS 5, CONSISTING OF BRACHIAL ANALYZER 5, CAROTID ANA MEDICAL IMAGING APPLICATIONS LLC 510(k) NO: K033266(TRADITIONAL) ATTN: MILAN SONKA PHONE NO : 319-358-1529 832 FOREST HILL DR SE DECISION MADE: 16-DEC-04 CORALVILLE, IA 52241 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: METRX WORKSTATION MEDICAL METRX SOLUTIONS, INC. 510(k) NO: K043134(TRADITIONAL) ATTN: PATSY J TRISLER PHONE NO : 301-652-5344 5610 WISCONSIN AVENUE,#304 SE DECISION MADE: 13-DEC-04 CHEVY CHASE, MD 20815 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SA8000 SE DIAGNOSTIC ULTRASOUND SYSTEM MEDISON CO., LTD. 510(k) NO: K043455(TRADITIONAL) ATTN: CARL ALLETTO PHONE NO : 940-300-8601 1600 MANCHESTER WAY SE DECISION MADE: 21-DEC-04 CORINTH, TX 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEM MEDRAD, INC. 510(k) NO: K042784(SPECIAL) ATTN: JOHN M KISTE PHONE NO : 412-767-2400 ONE MEDRAD DR. SE DECISION MADE: 10-DEC-04 INDIANOLA, PA 15051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDTRADE PRODUCTS ANTISEPTIC BARRIER SILVER FOAM DRESSING, MODEL MEDTRADE PRODUCTS LTD. 510(k) NO: K033732(TRADITIONAL) ATTN: JONATHAN D RANFIELD PHONE NO : 440 127 0500019 ELECTRA HOUSE SE DECISION MADE: 01-DEC-04 CREWE BUSINESS PARK CREWE 510(k) SUMMARY AVAILABLE FROM FDA CHESHIRE, UNITED KINGDOM CW1 6GL DEVICE: VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K042789(SPECIAL) ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 21-DEC-04 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K042962(TRADITIONAL) ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 14-DEC-04 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K043343(SPECIAL) ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 28-DEC-04 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K043561(SPECIAL) ATTN: RICHARD A TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 29-DEC-04 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 6F Z4 GUIDE CATHETER MEDTRONIC, INC. 510(k) NO: K042489(SPECIAL) ATTN: FRED L BOUCHER PHONE NO : 978-777-0042 37A CHERRY HILL DR. SE DECISION MADE: 13-DEC-04 DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR MEDTRONIC, INC. 510(k) NO: K043080(SPECIAL) ATTN: BRUCE BACKLUND PHONE NO : 763-391-9000 7611 NORTHLAND DR. SE DECISION MADE: 03-DEC-04 MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIOBLATE DISPERSIVE ELECTRODE ADAPTER (ACCESSORY), MODEL 6088 MEDTRONIC, INC. 510(k) NO: K043291(SPECIAL) ATTN: DAVID D COX PHONE NO : 763-391-9251 7601 NORTHLAND DR. SE DECISION MADE: 21-DEC-04 MINNEAPOLIS, MN 55428 510(k) STATEMENT DEVICE: PALMSCAN AP2000; PALMSCAN A2000; PALMSCAN P2000 MICRO MEDICAL DEVICES, INC. 510(k) NO: K043287(TRADITIONAL) ATTN: RAFI ISRAEL PHONE NO : 818-874-0000 5308 DERRY AVE., SUITE I-204 SE DECISION MADE: 10-DEC-04 AGOURA HILLS, CA 91301 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT18L1 MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K043110(SPECIAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 09-DEC-04 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ML830 LASER SYSTEM MICROLIGHT CORPORATION OF AMERICA 510(k) NO: K041364(TRADITIONAL) ATTN: FRED A SIMPSON PHONE NO : 713-752-4248 1401 MCKINNEY ST. SE DECISION MADE: 13-DEC-04 SUITE 1900 510(k) SUMMARY AVAILABLE FROM FDA HOUSTON, TX 77010 DEVICE: SCENIUM MIRADA SOLUTIONS LTD 510(k) NO: K042863(TRADITIONAL) ATTN: MARIA EBIO PHONE NO : 865-218-2534 810 INNOVATION DRIVE SE DECISION MADE: 15-DEC-04 KNOXVILLE, TN 37932 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFIED MSQ FAMILY OF LOVELY LIGHT/LASER SYSTEMS MSQ (M2) LTD. 510(k) NO: K042000(TRADITIONAL) ATTN: ANNE WORDEN PHONE NO : 925-895-1200 3637 BERNAL AVENUE SE DECISION MADE: 21-DEC-04 PLEASANTON, CA 94566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MTF ALLOGRAFT ANCHOR MUSCULOSKELETAL TRANSPLANT FOUNDAT510(k) NO: K042038(TRADITIONAL) ATTN: NORMAN F ESTRIN PHONE NO : 301-279-2899 9109 COPENHAVER DRIVE SE DECISION MADE: 23-DEC-04 POTOMAC, MD 20854 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR NELLCOR PURITAN BENNETT, INC. 510(k) NO: K033973(TRADITIONAL) ATTN: LUANNE NG PHONE NO : 925-463-4348 4280 HACIENDA DR. SE DECISION MADE: 13-DEC-04 PLEASANTON, CA 94588-2719 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEOSCI MEDICAL ENDOLUMINAL BRUSH NEOSCI MEDICAL, INC. 510(k) NO: K030400(TRADITIONAL) ATTN: PHIL TRIOLO PHONE NO : 801-328-1996 148 S. 1200 E. SE DECISION MADE: 22-DEC-04 SALT LAKE CITY, UT 84102 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEWPORT C250 AIR COMPRESSOR MODEL C250 NEWPORT MEDICAL INSTRUMENTS 510(k) NO: K041406(TRADITIONAL) ATTN: RICHARD WATERS PHONE NO : 949-642-3910 760 W 16TH STREET, BLDG. N SE DECISION MADE: 15-DEC-04 COSTA MESA, CA 92627 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMARTWAVE MS 2000 NEWWAVE MEDICAL LLC 510(k) NO: K041063(TRADITIONAL) ATTN: ROBERT ARMSTRONG PHONE NO : 972-516-8383 620 HAGGARD STREET SE DECISION MADE: 01-DEC-04 STE. 614 510(k) SUMMARY AVAILABLE FROM FDA PLANO, TX 75074 DEVICE: NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN NICHOLS INSTITUTE DIAGNOSTICS 510(k) NO: K042676(TRADITIONAL) ATTN: XIE QIYL PHONE NO : 949-940-7358 1311 CALLE BATIDO SE DECISION MADE: 17-DEC-04 SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: NICHOLS ADVANTAGE CORTISOL NICHOLS INSTITUTE DIAGNOSTICS 510(k) NO: K042689(TRADITIONAL) ATTN: JIMMY WONG PHONE NO : 949-940-7260 1311 CALLE BATIDO SE DECISION MADE: 09-DEC-04 SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300 NIDEK, INC. 510(k) NO: K042785(TRADITIONAL) ATTN: CAROL PATTERSON PHONE NO : 949-462-0900 21911 ERIE LN. SE DECISION MADE: 14-DEC-04 LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LAPAROSCOPIC COMPRESSION ANASTOMOSIS CLIP (LAPCAC) NITI MEDICAL TECHNOLOGIES LTD. 510(k) NO: K043115(TRADITIONAL) ATTN: ORLY MAOR PHONE NO : 972 9 8650610 1 HATZORAN ST. SE DECISION MADE: 01-DEC-04 P.O. BOX 8634 510(k) SUMMARY AVAILABLE FROM FDA NETANYA, ISRAEL 42506 DEVICE: TCM ENDO V, MODEL 1534 NOUVAG AG 510(k) NO: K042822(TRADITIONAL) ATTN: ERICH FORSTER PHONE NO : 004 156 2019500 REUSSWEHRSTRASSE 1 SE DECISION MADE: 22-DEC-04 GEBENSTORF, SWITZERLAND 5412 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOUVAG AG - VACUSON 40 AND VACUSON 60 NOUVAG AG 510(k) NO: K042943(TRADITIONAL) ATTN: ERICH FORSTER PHONE NO : 41 56 2019500 REUSSWEHRSTRASSE 1 SE DECISION MADE: 17-DEC-04 GEBENSTORF, SWITZERLAND 5412 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIES NOVALIS MEDICAL, LLC 510(k) NO: K043319(TRADITIONAL) ATTN: ANTHONY DAVIS PHONE NO : 813-849-6362 1719 W. KENNEDY BLVD. SE DECISION MADE: 17-DEC-04 TAMPA, FL 33606 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: OSS/(SCARF)- AND OSW-SCREW O.M.T. OBERFLACHEN-UND MATERIALTEC510(k) NO: K042079(TRADITIONAL) ATTN: H. DARREL DARBY II PHONE NO : 800-999-8866 1327 7TH AVENUE SE DECISION MADE: 20-DEC-04 HUNTINGTON, WV 25701 510(k) STATEMENT DEVICE: OLYMPUS LACTATE, OSR6193 OLYMPUS AMERICA, INC. 510(k) NO: K042406(TRADITIONAL) ATTN: BEV HARDING PHONE NO : 800-628-7152 3131 WEST ROYAL LN. SE DECISION MADE: 03-DEC-04 IRVING, TX 75063-3104 510(k) STATEMENT DEVICE: OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279 OLYMPUS AMERICA, INC. 510(k) NO: K043202(TRADITIONAL) ATTN: BEV HARDING PHONE NO : 972-556-9697 3131 WEST ROYAL LN. SE DECISION MADE: 23-DEC-04 IRVING, TX 75063-3104 510(k) STATEMENT DEVICE: OLYMPUS ENDOARM OLYMPUS CORPORATION 510(k) NO: K043128(TRADITIONAL) ATTN: TINA STEFFANIE-OAK PHONE NO : 631-844-5477 TWO CORPORATE CENTER DRIVE SE DECISION MADE: 21-DEC-04 MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K043275(TRADITIONAL) ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688 TWO CORPORATE CENTER DR. SE DECISION MADE: 09-DEC-04 MELVILLE, NY 11747-9058 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: COLD LIGHT; COLD LIGHT MD; GOSSAMER DERMLIGHT ONYX MEDICAL INC. 510(k) NO: K041679(ABBREVIATED) ATTN: ROGER MACHSON PHONE NO : 415-331-0193 445 COLOMA STREET SE DECISION MADE: 16-DEC-04 SAUSALITO, CA 94965 510(k) STATEMENT DEVICE: OPUS MINIMAGNUM ANCHOR WITH INSERTER OPUS MEDICAL, INC. 510(k) NO: K042584(TRADITIONAL) ATTN: LAURA N KASPEROWICZ PHONE NO : 949-234-0400 27127 CALLE ARROYO, SUITE 1924 SE DECISION MADE: 14-DEC-04 SAN JUAN CAPISTRANO, CA 92675 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K042476(TRADITIONAL) ATTN: CAREY A MAYO PHONE NO : 585-453-3482 100 INDIGO CREEK DR. SE DECISION MADE: 01-DEC-04 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 23; VITROS CHEMISTRY PR ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K042838(TRADITIONAL) ATTN: DARLENE J PHILLIPS PHONE NO : 585-453-4253 100 INDIGO CREEK DR. SE DECISION MADE: 09-DEC-04 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLYGRAFT BGS; BONE GRAFT SUBSTITUTE OSTEOBIOLOGICS, INC. 510(k) NO: K040047(TRADITIONAL) ATTN: GABRIELE G NIEDERAUER PHONE NO : 210-690-2131 12500 NETWORK SE DECISION MADE: 17-DEC-04 SUITE 112 510(k) SUMMARY AVAILABLE FROM FDA SAN ANTONIO, TX 78249 DEVICE: MODIFICATION TO: PLEXALONG SETS PAJUNK GMBH 510(k) NO: K042979(SPECIAL) ATTN: BURK A BRANDT PHONE NO : 541-752-3953 5010 NW CRESCENT VALLEY DR. SE DECISION MADE: 21-DEC-04 CORVALLIS, OR 97330 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS PAJUNK GMBH 510(k) NO: K043130(SPECIAL) ATTN: BURK A BRANDT PHONE NO : 541-752-3953 5101 NW CRESCENT VALLEY DR. SE DECISION MADE: 21-DEC-04 CORVALLIS, OR 97330 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEEDLE INCAPACITATOR (NEEDLE GUARD) PDMP, INC. 510(k) NO: K042907(TRADITIONAL) ATTN: E.J. SMITH PHONE NO : 410-451-0639 P.O. BOX 4341 SE DECISION MADE: 22-DEC-04 CROFTON, MD 21114 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: PEFAKIT APC-R FACTOR V LEIDEN CONTROLS PENTAPHARM LTD. 510(k) NO: K042760(ABBREVIATED) ATTN: M. ELISABETH BIERMAN PHONE NO : 202-739-5206 1111 PENNSYLVANIA AVE., NW SE DECISION MADE: 22-DEC-04 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PEFAKIT APC-R FACTOR V LEIDEN PENTAPHARM LTD. 510(k) NO: K042762(TRADITIONAL) ATTN: M. ELISABETH BIERMAN PHONE NO : 202-739-5206 1111 PENNSYLVANIA AVE., NW SE DECISION MADE: 22-DEC-04 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON PERUSAHAAN GETAH ASAS SDN BHD 510(k) NO: K042805(TRADITIONAL) ATTN: KK LEONG PHONE NO : 603 329 11949 LOT 754, JALAN HAJI SIRAT SE DECISION MADE: 16-DEC-04 KLANG, SELANGOR, MALAYSIA 42100 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9 PHAMATECH INC. 510(k) NO: K043167(SPECIAL) ATTN: CARL MONGIOVI PHONE NO : 858-643-5555 10151 BARNES CANYON RD SE DECISION MADE: 29-DEC-04 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD PHONIC EAR, INC. 510(k) NO: K043090(TRADITIONAL) ATTN: TODD BISSEY PHONE NO : 707-769-1110 3880 CYPRESS DR. SE DECISION MADE: 23-DEC-04 PETALUMA, CA 94954-7600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7015 PROGENY, INC. 510(k) NO: K043092(TRADITIONAL) ATTN: ALAN KREMA PHONE NO : 847-850-3800 1407 BARCLAY BLVD. SE DECISION MADE: 13-DEC-04 BUFFALO GROVE, IL 60089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROMEDICAL SURGICAL GOWNS PROMEDICAL PRODUCTS CO., LTD. 510(k) NO: K042111(TRADITIONAL) ATTN: BOYD HARRIS PHONE NO : 662-352-1910 125 CLEMENTS AVE. SE DECISION MADE: 10-DEC-04 STARKVILLE, MS 39759 510(k) STATEMENT DEVICE: PROMEDICAL SURGICAL DRAPES PROMEDICAL PRODUCTS CO., LTD. 510(k) NO: K042131(TRADITIONAL) ATTN: BOYD HARRIS PHONE NO : 662-352-1910 125 CLEMENTS AVE. SE DECISION MADE: 10-DEC-04 STARKVILLE, MS 39759 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXISKIN POWDER FREE NITRILE EXAMINATION GLOVES, NON STERILE PT. MANDIRI INTI BUANA 510(k) NO: K042239(TRADITIONAL) ATTN: P. SASITHARAN NAIR PHONE NO : 62 61 7944880 JALAN SEI BELUMAI SE DECISION MADE: 16-DEC-04 DESA DALU 10 A DUSUN 1 510(k) SUMMARY AVAILABLE FROM FDA TANJUNG MORAWA, SUMUT, INDONESIA 20362 DEVICE: POWDERFREE COLORED AND FLAVORED CHLOREPRENE PATIENT EXAMINATION PT. MEDISAFE TECHNOLOGIES 510(k) NO: K041913(TRADITIONAL) ATTN: ANIL TANEJA PHONE NO : 62 061 7941463 GG. TAMBAK REJO SE DECISION MADE: 01-DEC-04 DESA BUNTU BEDIMBAR 510(k) STATEMENT TANJUNG MORAWA, MEDAN, INDONESIA 20362 DEVICE: TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPA RETINAPHARMA TECHNOLOGIES INC. 510(k) NO: K042099(TRADITIONAL) ATTN: TERRY A FULLER, PH.D. PHONE NO : 215-885-4558 944 MORGAN ROAD SE DECISION MADE: 10-DEC-04 JENKINTOWN, PA 19046 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO SHORT INTRODUCER SHEATH REX MEDICAL LP 510(k) NO: K042399(SPECIAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502 55 NORTHERN BLVD. SE DECISION MADE: 17-DEC-04 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 11021 DEVICE: ONLINE DAT BARBITURATES PLUS ROCHE DIAGNOSTICS CORP. 510(k) NO: K043211(TRADITIONAL) ATTN: KERWIN KAUFMAN PHONE NO : 317-521-7637 9115 HAGUE RD. SE DECISION MADE: 29-DEC-04 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY ROCHE DIAGNOSTICS CORP. 510(k) NO: K043318(SPECIAL) ATTN: KAY A TAYLOR PHONE NO : 317-521-3544 9115 HAGUE RD. SE DECISION MADE: 23-DEC-04 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II ROCHE DIAGNOSTICS CORP. 510(k) NO: K043320(SPECIAL) ATTN: KAY A TAYLOR PHONE NO : 317-521-3544 9115 HAGUE RD. SE DECISION MADE: 17-DEC-04 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROTECTION PLUS EARLOOP PROCEDURE MASK SAFETY-MED PRODUCTS, INC. 510(k) NO: K042654(TRADITIONAL) ATTN: CHRIS WAGNER PHONE NO : 262-767-9674 140 LONGMEADOW DRIVE SE DECISION MADE: 17-DEC-04 BURLINGTON, WI 53105 510(k) STATEMENT DEVICE: ULTRALIGHT II ND:YAG LASER SYSTEM SANDSTONE MEDICAL TECHNOLOGIES, LL510(k) NO: K041011(TRADITIONAL) ATTN: CONNIE WHITE HOY PHONE NO : 530-666-7616 908 STETSON STREET SE DECISION MADE: 14-DEC-04 WOODLAND, CA 95776 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IS 40 MICROMOTOR SATELEC 510(k) NO: K042787(TRADITIONAL) ATTN: STEVE SALESKY PHONE NO : 856-222-9988 130 GAITHER DRIVE SE DECISION MADE: 17-DEC-04 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA MT. LAUREL, NJ 08054 DEVICE: MX POLYAXIAL PEDICLE SCREW SCIENT'X 510(k) NO: K043001(SPECIAL) ATTN: J.D. WEBB PHONE NO : 512-388-0199 1001 OAKWOOD BLVD. SE DECISION MADE: 01-DEC-04 ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UCR SPINAL SYSTEM SEASPINE 510(k) NO: K043232(TRADITIONAL) ATTN: DIANA SMITH PHONE NO : 760-727-8399 2303 LA MIRADA DRIVE SE DECISION MADE: 21-DEC-04 VISTA, CA 92081-7862 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE CLEAR SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MED SHIJAIZHUANG BRILLIANT OCEAN PLAST510(k) NO: K043159(TRADITIONAL) ATTN: EMMY TJOENG PHONE NO : 909-591-8855 5445 DANIELS STREET SE DECISION MADE: 20-DEC-04 CHINO, CA 91710 510(k) STATEMENT DEVICE: SHIMADZU COLLIMATOR R-20J SHIMADZU CORP. 510(k) NO: K042840(ABBREVIATED) ATTN: RANDAL WALKERI PHONE NO : 310-217-8855 20101 SOUTH VERMONT AVE. SE DECISION MADE: 03-DEC-04 TORRANCE, CA 90502-1328 510(k) STATEMENT DEVICE: MEGNETOM C! MR SYSTEM SIEMENS MEDICAL SOLUTIONS 510(k) NO: K043030(TRADITIONAL) ATTN: NEALIE HARTMAN PHONE NO : 610-448-1769 51 VALLEY STREAM PARKWAY E50 SE DECISION MADE: 09-DEC-04 MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOMATOM RESPIRATORY GATING SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K043086(TRADITIONAL) ATTN: DEBBIE PEACOCK PHONE NO : 610-448-1769 51 VALLEY STREAM PKWY. SE DECISION MADE: 23-DEC-04 MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOMATOM CARE CONTRAST CT SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K043087(TRADITIONAL) ATTN: DEBBIE PEACOCK PHONE NO : 610-448-1773 51 VALLEY STREAM PKWY. SE DECISION MADE: 15-DEC-04 MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVE SINTEA BIOTECH, INC. 510(k) NO: K043355(SPECIAL) ATTN: GUIDO ZORZOLI PHONE NO : 305-673-6226 407 LINCOLN RD. SUITE 10L SE DECISION MADE: 17-DEC-04 MIAMI BEACH, FL 33139 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TITAN HIGH RESOLUTION ULTRASOUND SYSTEM AND SONOSITE ULTRASOUND SONOSITE,INC. 510(k) NO: K043452(TRADITIONAL) ATTN: DAINA L GRAHAM PHONE NO : 425-951-1275 21919 30TH DRIVE SE. SE DECISION MADE: 21-DEC-04 BOTHELL, WA 98021-3904 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-30 SOPHYSA SA 510(k) NO: K042481(TRADITIONAL) ATTN: JACKIE MASSE PHONE NO : 781-239-8108 70 WALNUT ST. SE DECISION MADE: 14-DEC-04 WELLESLEY, MA 02481 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRANEX D SOREDEX INSTRUMENTARIUM CORP. 510(k) NO: K043307(TRADITIONAL) ATTN: KAI LANER PHONE NO : 358 103 94820 NAHKELANTIE 160 SE DECISION MADE: 17-DEC-04 TUUSULA, FINLAND 00430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL SR-130-D PORTABLE DIGITAL X-RAY SYSTEM SOURCE-RAY, INC. 510(k) NO: K043062(TRADITIONAL) ATTN: RAY MANEZ PHONE NO : 631-244-8200 167 KEYLAND CT. SE DECISION MADE: 13-DEC-04 BOHEMIA, NY 11716 510(k) STATEMENT DEVICE: RIVA SILVER SOUTHERN DENTAL INDUSTRIES, INC. 510(k) NO: K042452(TRADITIONAL) ATTN: SAMANTHA J CHEETHAM PHONE NO : 630-238-8300 729 N. ROUTE 83, SUITE 315 SE DECISION MADE: 07-DEC-04 BENSENVILLE, IL 60106 510(k) STATEMENT DEVICE: FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 5 SPINE NEXT AMERICA CORPORATION 510(k) NO: K042713(TRADITIONAL) ATTN: TOM BREWER PHONE NO : 904-363-3448 8381 DIX ELLIS TRAIL, STE. 110 SE DECISION MADE: 29-DEC-04 JACKSONVILLE, FL 32256 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 1, 2, 3 AND 4 SPINE NEXT AMERICA CORPORATION 510(k) NO: K042714(TRADITIONAL) ATTN: TOM BREWER PHONE NO : 904-363-3448 8381 DIX ELLIS TRAIL, STE. 110 SE DECISION MADE: 29-DEC-04 JACKSONVILLE, FL 32256 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PEDIGUARD NERVE DETECTOR SYSTEM SPINEVISION, INC. 510(k) NO: K030526(TRADITIONAL) ATTN: LYNNETTE WHITAKER PHONE NO : 574-269-9776 3003 SUMMIT BLVD. SE DECISION MADE: 29-DEC-04 SUITE 1400 510(k) SUMMARY AVAILABLE FROM FDA ATLANTA, GA 30319 DEVICE: SPACEVISION CAGE SYSTEM SPINEVISION, INC. 510(k) NO: K042930(TRADITIONAL) ATTN: LYNETTE WHITAKER PHONE NO : 574-269-9776 3003 SUMMIT BLVD. STE 1400 SE DECISION MADE: 28-DEC-04 ATLANTA, GA 30319 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 55CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEPARAT SPIRE BIOMEDICAL, INC. 510(k) NO: K042858(TRADITIONAL) ATTN: DONALD FICKETT PHONE NO : 781-275-6001 ONE PATRIOTS PARK SE DECISION MADE: 03-DEC-04 BEDFORD, MA 01730-2396 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SJM RIGID SADDLE RING MODEL RSAR-(SIZE) ST. JUDE MEDICAL, INC. 510(k) NO: K042734(TRADITIONAL) ATTN: WILLIAM MCKELVEY PHONE NO : 651-415-7029 ONE LILLEHEI PLAZA SE DECISION MADE: 17-DEC-04 ST. PAUL, MN 55117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STARION UNIVERSAL POWER SUPPLY (UPS) STARION INSTRUMENTS 510(k) NO: K043155(SPECIAL) ATTN: BRIAN GRIGSBY PHONE NO : 408-741-8773 20665 4TH ST. SE DECISION MADE: 09-DEC-04 SARATOGA, CA 95070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SERFAS ENERGY SYSTEM STRYKER ENDOSCOPY 510(k) NO: K041810(TRADITIONAL) ATTN: CHRISTINE REISTETTER PHONE NO : 408-754-2229 5900 OPTICAL CT. SE DECISION MADE: 21-DEC-04 SAN JOSE, CA 95138 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: STRYKER CASSETTE PUMP STRYKER ENDOSCOPY 510(k) NO: K042454(TRADITIONAL) ATTN: CHRISTOPHER L COOK PHONE NO : 408-754-2288 5900 OPTICAL CT. SE DECISION MADE: 09-DEC-04 SAN JOSE, CA 95138 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HERBERT ULNAR HEAD PROSTHESIS SYSTEM STUCKENBROCK MEDIZINTECHNIK GMBH 510(k) NO: K042902(TRADITIONAL) ATTN: AL WEISENBORN PHONE NO : 305-829-3437 12244 SW 130 ST. SE DECISION MADE: 27-DEC-04 MIAMI, FL 33186 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONTOUR FOREHEAD/BROWLIFT THREAD SURGICAL SPECIALTIES CORP. 510(k) NO: K042856(TRADITIONAL) ATTN: ELIZABETH LAZARO PHONE NO : 800-523-3332 100 DENNIS DR. SE DECISION MADE: 03-DEC-04 READING, PA 19606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VARELISA SM ANTIBODIES, MODEL 18296 SWEDEN DIAGNOSTICS (GERMANY) GMBH 510(k) NO: K042629(TRADITIONAL) ATTN: SABINE KLUGBAUER PHONE NO : 497 614 7805419 MUNZINGER STRASSE 7 SE DECISION MADE: 08-DEC-04 FREIBURG, GERMANY D-79111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER TAKARA BELMONT USA, INC. 510(k) NO: K041834(TRADITIONAL) ATTN: ROBERT SCHIFF PHONE NO : 973-227-1830 1129 BLOOMFIELD AVENUE SE DECISION MADE: 03-DEC-04 WEST CALDWELL, NJ 07006 510(k) STATEMENT DEVICE: TANITA INNERSCAN BODY COMPOSITION MONITOR, MODEL BC-53X (WHERE X TANITA CORP. OF AMERICA 510(k) NO: K040778(TRADITIONAL) ATTN: RHODA LYNN VALERA PHONE NO : 847-434-3966 2625 SOUTH CLEARBROOK DR. SE DECISION MADE: 23-DEC-04 ARLINGTON HGTS., IL 60005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISIOPLAST ACRYLIC RESIN TECRES 510(k) NO: K042414(TRADITIONAL) ATTN: CHRISTINE BRAUER PHONE NO : 301-545-1990 ONE DEMOCRACY PLAZA SE DECISION MADE: 29-DEC-04 6701 DEMOCRACT BLVD. STE. 700 510(k) SUMMARY AVAILABLE FROM FDA BETHESDA, MD 20817 DEVICE: CEMENTEK LV TEKNIMED SA 510(k) NO: K042911(SPECIAL) ATTN: J.D. WEBB PHONE NO : 512-388-0199 1001 OAKWOOD BLVD SE DECISION MADE: 27-DEC-04 ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER, PART NO. T46 TELEFLEX MEDICAL 510(k) NO: K043258(SPECIAL) ATTN: SUSAN KAGAN PHONE NO : 508-677-6675 50 PLANTATION DRIVE SE DECISION MADE: 16-DEC-04 TALL PINES PARK 510(k) SUMMARY AVAILABLE FROM FDA JAFFERY, NH 03452 DEVICE: TERATECH MODEL 8IOC4, 8IOL4 & 10LAP4 PROBES TERATECH CORP. 510(k) NO: K043278(TRADITIONAL) ATTN: CHARLES F HOTTINGER PHONE NO : 206-780-7945 PO BOX 10074 SE DECISION MADE: 13-DEC-04 13221 NE TEEM LOOP ROAD 510(k) SUMMARY AVAILABLE FROM FDA BAINBRIDGE ISLAND, WA 98110 THIRD PARTY REVIEW DEVICE: SONATA 3-D IMAGING ACCESSORY, MODEL 3DS TETRAD CORP. 510(k) NO: K042620(TRADITIONAL) ATTN: DENNIS R DIETZ PHONE NO : 303-754-2320 357 INVERNESS DR. SOUTH, SE DECISION MADE: 23-DEC-04 SUITE A 510(k) SUMMARY AVAILABLE FROM FDA ENGLEWOOD, CO 80112 DEVICE: ANSPACH "MINIMAL ACCESS SPINAL ATTACHMENT" (MASA) SYSTEM THE ANSPACH EFFORT, INC. 510(k) NO: K042783(TRADITIONAL) ATTN: WILLIAM G CONETY PHONE NO : 561-627-1080 4500 RIVERSIDE DR. SE DECISION MADE: 17-DEC-04 PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MD-6W WIRELESS CRITICAL DATA VIEWER THE MICROOPTICAL CORPORATION 510(k) NO: K042923(TRADITIONAL) ATTN: DANIEL J DILLON PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 17-DEC-04 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERMACOL SURGICAL IMPLANT TISSUE SCIENCE LABORATORIES, PLC 510(k) NO: K043366(TRADITIONAL) ATTN: VICTORIA TAYLOR PHONE NO : 678-342-7808 1141 CLARK STREET, SUITE D SE DECISION MADE: 17-DEC-04 COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TORAYGUIDE GUIDEWIRE TORAY INDUSTRIES (AMERICA), INC. 510(k) NO: K042370(TRADITIONAL) ATTN: LISA S JONES PHONE NO : 713-664-6775 540 COLLEGE ST. SE DECISION MADE: 17-DEC-04 BELLAIRE, TX 77401-5010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM; AEQUALIS SHOU TORNIER S.A. 510(k) NO: K043077(TRADITIONAL) ATTN: LEMERY MIREILLE PHONE NO : 33 476 613898 161 RUE LAVOISIER SE DECISION MADE: 17-DEC-04 MONTBONNOT, SAINT-ISMIER, FRANCE 3510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRANS1 AXIAL FIXATION SYSTEM TRANS1, INC. 510(k) NO: K040426(TRADITIONAL) ATTN: CHERYL L JOHNS PHONE NO : 910-509-3100 1800 SIR TYLER DRIVE SE DECISION MADE: 17-DEC-04 SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA WILMINGTON, NC 28405 DEVICE: ULTRADENT CARBON MASK - UPI #342 ULTRADENT PRODUCTS, INC. 510(k) NO: K041047(ABBREVIATED) ATTN: TAMMY LAVERY PHONE NO : 800-552-5513 505 WEST 10200 SOUTH SE DECISION MADE: 01-DEC-04 SOUTH JORDAN, UT 84095 510(k) STATEMENT DEVICE: AMELOGEN PLUS ULTRADENT PRODUCTS, INC. 510(k) NO: K043119(SPECIAL) ATTN: TAMMY LAVERY PHONE NO : 801-553-4323 505 WEST 10200 SOUTH SE DECISION MADE: 17-DEC-04 SOUTH JORDAN, UT 84095 510(k) STATEMENT DEVICE: UNISILK UNITED MEDICAL INDUSTRIES CO. LTD.510(k) NO: K042282(TRADITIONAL) ATTN: MOHAMMED AZEEZ PHONE NO : 009 661 2650665 3RD INDUSTRIAL CITY SE DECISION MADE: 01-DEC-04 SANAYYA, OPPOSITE TO OBAIKAN 510(k) STATEMENT RIYADH, CENTRAL PROVINCE, SAUDI ARABIA 11553 DEVICE: UNIPRO UNITED MEDICAL INDUSTRIES CO. LTD.510(k) NO: K042283(TRADITIONAL) ATTN: MOHAMMED AZEEZ PHONE NO : 009 661 2650665 3RD INDUSTRIAL CITY SE DECISION MADE: 01-DEC-04 SANAYYA, OPPOSITE TO OBAIKAN 510(k) STATEMENT RIYADH, CENTRAL PROVINCE, SAUDI ARABIA 11553 DEVICE: UNIMIDE UNITED MEDICAL INDUSTRIES CO. LTD.510(k) NO: K042284(TRADITIONAL) ATTN: MOHAMMED AZEEZ PHONE NO : 009 661 2650665 3RD INDUSTRIAL CITY SE DECISION MADE: 03-DEC-04 SANAYYA, OPPOSITE TO OBAIKAN 510(k) STATEMENT RIYADH, CENTRAL PROVINCE, SAUDI ARABIA 11553 DEVICE: UNICRYL M UNITED MEDICAL INDUSTRIES CO. LTD.510(k) NO: K042285(TRADITIONAL) ATTN: MOHAMMED AZEEZ PHONE NO : 009 661 2650665 3RD INDUSTRIAL CITY SE DECISION MADE: 10-DEC-04 SANAYYA, OPPOSITE TO OBAIKAN 510(k) STATEMENT RIYADH, CENTRAL PROVINCE, SAUDI ARABIA 11553 DEVICE: UNIESTER C UNITED MEDICAL INDUSTRIES CO. LTD.510(k) NO: K042286(TRADITIONAL) ATTN: MOHAMMED AZEEZ PHONE NO : 009 661 2650665 3RD INDUSTRIAL CITY SE DECISION MADE: 01-DEC-04 SANAYYA, OPPOSITE TO OBAIKAN 510(k) STATEMENT RIYADH, CENTRAL PROVINCE, SAUDI ARABIA 11553 DEVICE: UNICRYL UNITED MEDICAL INDUSTRIES CO. LTD.510(k) NO: K042288(TRADITIONAL) ATTN: MOHAMMED AZEEZ PHONE NO : 009 661 2650665 3RD INDUSTRIAL CITY SE DECISION MADE: 27-DEC-04 SANAYYA, OPPOSITE TO OBAIKAN 510(k) STATEMENT RIYADH, CENTRAL PROVINCE, SAUDI ARABIA 11553 DEVICE: VASCULAR SOLUTIONS SCLERO-KIT VASCULAR SOLUTIONS, INC. 510(k) NO: K043019(TRADITIONAL) ATTN: SARA L COON PHONE NO : 763-656-4399 6464 SYCAMORE COURT NORTH SE DECISION MADE: 01-DEC-04 MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM VERTEBRON, INC. 510(k) NO: K043181(SPECIAL) ATTN: LUIS NESPRIDO PHONE NO : 203-380-3940 400 LONG BEACH BLVD. SE DECISION MADE: 17-DEC-04 STRATFORD, CT 06615 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORTRAK VIASYS MEDSYSTEMS 510(k) NO: K041987(TRADITIONAL) ATTN: STEPHANIE WASIELEWSKI PHONE NO : 847-353-1348 100 CHADDICK DR. SE DECISION MADE: 17-DEC-04 WHEELING, IL 60090 510(k) STATEMENT DEVICE: VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEM VITAL IMAGES, INC. 510(k) NO: K043333(ABBREVIATED) ATTN: TIMOTHY J KAPPERS PHONE NO : 763-852-6914 3300 FERNBROOK LN. NORTH SE DECISION MADE: 15-DEC-04 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA PLYMOUTH, MN 55447 THIRD PARTY REVIEW DEVICE: GORE POLYPROPYLENE HERNIA MESH W. L. GORE & ASSOCIATES, INC. 510(k) NO: K043081(TRADITIONAL) ATTN: MICHAEL IVEY PHONE NO : 928-864-3790 3450 WEST KILTIE LN. SE DECISION MADE: 22-DEC-04 FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL W.L. GORE & ASSOCIATES,INC 510(k) NO: K043056(TRADITIONAL) ATTN: BRANDON HANSON PHONE NO : 928-864-3784 3750 WEST KILTIE LN. SE DECISION MADE: 22-DEC-04 FLAGSTAFF, AZ 86002-0900 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONSERVE PLUS HA ACETABULAR SHELLS WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K042530(SPECIAL) ATTN: JEANINE H REDDEN PHONE NO : 901-867-4522 5677 AIRLINE RD. SE DECISION MADE: 17-DEC-04 ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700 YOUNG O/S LLC 510(k) NO: K042828(ABBREVIATED) ATTN: STEPHEN W CONGER PHONE NO : 636-343-8300 1663 FENTON BUSINESS PARK CT. SE DECISION MADE: 01-DEC-04 FENTON, MO 63026 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TORPICALGIN ZHERMACK S.P.A. 510(k) NO: K043131(TRADITIONAL) ATTN: GERALD W SHIPPS PHONE NO : 541-389-5935 19379 BLUE LAKE LOOP SE DECISION MADE: 15-DEC-04 BEND, OR 97702 510(k) STATEMENT DEVICE: TRABECULAR METAL ACETABULAR AUGMENTS, MODELS 4894-XXX-YY, 02-212 ZIMMER TRABECULAR 510(k) NO: K042871(SPECIAL) ATTN: MARCI HALEVI PHONE NO : 201-818-1800 80 COMMERCE DR. SE DECISION MADE: 21-DEC-04 ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERIARTICULAR LOCKING PLATES, 2358 SERIES ZIMMER, INC. 510(k) NO: K043227(SPECIAL) ATTN: NOAH BARTSCH PHONE NO : 574-371-8552 P.O. BOX 708 SE DECISION MADE: 10-DEC-04 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 284 TOTAL WITH SUMMARIES 226 TOTAL WITH STATEMENTS 58
Updated January 5, 2005
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