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510(k)s Final Decisions Rendered for October 2004 |
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SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-OCT-2004 THROUGH 31-OCT-2004 DEVICE: 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000 3M COMPANY 510(k) NO: K041934(TRADITIONAL) ATTN: GINGER CANTOR PHONE NO : 651-736-2101 3M CENTER, BLDG. 275-5W-06 SE DECISION MADE: 15-OCT-04 ST. PAUL, MN 55144-1000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYST A.M. SURGICAL, INC. 510(k) NO: K042458(TRADITIONAL) ATTN: CAROLANN KOTULA PHONE NO : 770-985-8203 55 NORTHERN BLVD. SE DECISION MADE: 07-OCT-04 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 11021 DEVICE: XPAND BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM, MODE ABBOT LABORATORIES 510(k) NO: K041962(TRADITIONAL) ATTN: JOANNA KUSKOWSKI PHONE NO : 650-474-3331 400 SAGINAW DR. SE DECISION MADE: 01-OCT-04 REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERIFYNOW-ASPIRIN ASSAY ACCUMETRICS, INC. 510(k) NO: K042423(SPECIAL) ATTN: BARBARA STEVENS PHONE NO : 858-404-8281 3985 SORRENTO VALLEY BLVD. SE DECISION MADE: 06-OCT-04 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUMED ANATOMIC RADIAL HEAD SYSTEM ACUMED LLC 510(k) NO: K041858(TRADITIONAL) ATTN: ED BOEHMER PHONE NO : 503-627-9957 5885 NW CORNELIUS PASS RD. SE DECISION MADE: 05-OCT-04 HILLSBORO, OR 97124-9432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUMEN SHEATH, MODEL TTW7807 ACUMEN MEDICAL, INC. 510(k) NO: K042376(TRADITIONAL) ATTN: MARYBETH GAMBER PHONE NO : 650-352-5700 1400 TERRA BELLA BLVD. SE DECISION MADE: 26-OCT-04 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTOSPECS ADAC LABORATORIES 510(k) NO: K042903(TRADITIONAL) ATTN: JOY SACMAR PHONE NO : 408-468-3053 540 ALDER DR. SE DECISION MADE: 29-OCT-04 MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: APNEA RISK EVALUATION SYSTEM (ARES) ADVANCED BRAIN MONITORING, INC. 510(k) NO: K041662(TRADITIONAL) ATTN: DANIEL J LEVENDOWSKI PHONE NO : 760-720-0099 2850 PIO PICO DRIVE SE DECISION MADE: 14-OCT-04 SUITE A 510(k) SUMMARY AVAILABLE FROM FDA CARLSBAD, CA 92008 DEVICE: COMPLETE BLINK-N-CLEAN LENS DROPS ADVANCED MEDICAL OPTICS, INC. 510(k) NO: K040839(ABBREVIATED) ATTN: PAUL J NOWACKI PHONE NO : 714-247-8609 1700 E. ST. ANDREW PLACE SE DECISION MADE: 19-OCT-04 P.O. BOX 25162 510(k) SUMMARY AVAILABLE FROM FDA SANTA ANA, CA 92799-5162 DEVICE: MPM SYSTEM AEROTEL MEDICAL SYSTEMS, LTD. 510(k) NO: K041854(TRADITIONAL) ATTN: GEORGE MYERS PHONE NO : 201-737-1703 377 ROUTE 17 S SE DECISION MADE: 06-OCT-04 HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AESKULISA DS DNA G AESKU.DIAGNOSTICS 510(k) NO: K041628(TRADITIONAL) ATTN: STANLEY AMMONS PHONE NO : 703-860-5057 8880 NW 18TH TERRACE SE DECISION MADE: 14-OCT-04 MIAMI, FL 33172 510(k) STATEMENT DEVICE: RADIOTHERAPY SOLUTION BASED ON CR AGFA CORP. 510(k) NO: K042779(TRADITIONAL) ATTN: JEFFERY A JEDLICKA PHONE NO : 864-421-1815 10 SOUTH ACADEMY ST. SE DECISION MADE: 21-OCT-04 GREENVILLE, SC 29601 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SCANX 14 AIR TECHNIQUES, INC. 510(k) NO: K042397(SPECIAL) ATTN: JOSEPH CAREY PHONE NO : 516-214-5541 70 CANTIAGUE ROCK RD. SE DECISION MADE: 05-OCT-04 PO BOX 870 510(k) STATEMENT HICKSVILLE, NY 11802-0870 DEVICE: NOVEL VBR SPINAL SYSTEM ALPHATEC/NEXMED 510(k) NO: K042201(TRADITIONAL) ATTN: ELLEN YARNALL PHONE NO : 760-431-9286 6110 CORTE DEL CEDRO SE DECISION MADE: 07-OCT-04 CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALPHATEC FEMORAL TROCHANTERIC NAIL (FTN) SYSTEM ALPHATEC/NEXMED 510(k) NO: K042440(TRADITIONAL) ATTN: ELLEN YARNALL PHONE NO : 760-431-9286 6110 CORTE DEL CEDRO SE DECISION MADE: 07-OCT-04 CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM ALPHATEC/NEXMED 510(k) NO: K042673(SPECIAL) ATTN: ELLEN A YARNALL PHONE NO : 760-431-9286 6110 CORTE DEL CEDRO SE DECISION MADE: 27-OCT-04 CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMERICAN BANTEX HUMIDIFIER, DRY, BUBBLE, MODELS B9000, 3 PSI AND AMERICAN BANTEX CORP. 510(k) NO: K041963(TRADITIONAL) ATTN: TRACY S BEST PHONE NO : 801-295-0748 994 NORTH MAIN STREET SE DECISION MADE: 20-OCT-04 BOUNTIFUL, UT 84010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMERICAN BANTEX, MODEL MS 3 AMERICAN BANTEX CORP. 510(k) NO: K042104(TRADITIONAL) ATTN: TRACY S BEST PHONE NO : 801-295-0748 994 NORTH MAIN STREET SE DECISION MADE: 21-OCT-04 BOUNTIFUL, UT 84010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VARI-ABLE APB (ADAPTABLE POSITIONING BASE) AMERICAN TRACK ROADSTERS, INC. 510(k) NO: K042401(TRADITIONAL) ATTN: GREG PEEK PHONE NO : 303-986-9300 3535 SOUTH KIPLING STREET SE DECISION MADE: 07-OCT-04 LAKEWOOD, CO 80235 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL DETECTOR, MODEL GR17 ANRAD CORP. 510(k) NO: K042821(ABBREVIATED) ATTN: DONALD J SHERRATT PHONE NO : 978-977-3000 8 CENTENNIAL DRIVE SE DECISION MADE: 22-OCT-04 PEABODY, MA 01960 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MODIFICATION TO URETERAL STENT APPLIED MEDICAL RESOURCES CORP. 510(k) NO: K040760(SPECIAL) ATTN: CHERYL BLAKE PHONE NO : 949-713-8327 22872 AVENIDA EMPRESSA SE DECISION MADE: 15-OCT-04 RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRAVASCULAR ACCESS INTRODUCER SHEATH APPLIED MEDICAL RESOURCES CORP. 510(k) NO: K041506(SPECIAL) ATTN: CHERYL BLAKE PHONE NO : 949-713-8327 22872 AVENIDA EMPRESA SE DECISION MADE: 15-OCT-04 RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMT INTRODUCER: MINI BUTTON DELIVERY SYSTEM APPLIED MEDICAL TECHNOLOGY, INC. 510(k) NO: K042300(TRADITIONAL) ATTN: CHRIS ZANTOPULOS PHONE NO : 216-475-5577 15653 NEO PKWY. SE DECISION MADE: 25-OCT-04 CLEVELAND, OH 44128 510(k) STATEMENT DEVICE: FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST ARMKEL LLC 510(k) NO: K040866(TRADITIONAL) ATTN: STEPHEN C KOLAKOWSKY PHONE NO : 609-279-7748 469 NORTH HARRISON STREET SE DECISION MADE: 19-OCT-04 PRINCETON, NJ 08543 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NYLON THREADED NEEDLE AROS SURGICAL INSTRUMENTS CORP. 510(k) NO: K042367(ABBREVIATED) ATTN: GRACE HOLLAND PHONE NO : 949-262-0411 3722 AVE. SAUSALITO SE DECISION MADE: 14-OCT-04 IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SILICONE COATED GUIDEWIRE ARROW INTERNATIONAL, INC. 510(k) NO: K041740(TRADITIONAL) ATTN: SUZANNE SCHORLE PHONE NO : 610-378-0131 2400 BERNVILLE RD. SE DECISION MADE: 15-OCT-04 READING, PA 19612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TI - SCREW ANCHOR SP ARTHROTEK, INC. 510(k) NO: K042460(TRADITIONAL) ATTN: GARY BAKER PHONE NO : 574-267-6639 56 EAST BELL DR. SE DECISION MADE: 29-OCT-04 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581 DEVICE: PRESS TACK NEEDLE ASIA-MED GMBH & CO. KG. - WERK SUH510(k) NO: K042063(TRADITIONAL) ATTN: KEVIN WALLS PHONE NO : 720-962-5412 13 RED FOX LANE SE DECISION MADE: 14-OCT-04 LITTLETON, CO 80127 510(k) STATEMENT DEVICE: AXYA MEDICAL, INC. MODEL 5000 AXYALOOP BIO-ABSORBABLE BONE ANCHO AXYA MEDICAL, INC. 510(k) NO: K041698(TRADITIONAL) ATTN: HOWARD SCHRAYER PHONE NO : 978-232-9997 100 CUMMINGS CENTER SE DECISION MADE: 05-OCT-04 SUITE 444C 510(k) SUMMARY AVAILABLE FROM FDA BEVERLY, MA 01915 DEVICE: PINNACLE TPN MANAGEMENT SYSTEM TRANSFER SET B. BRAUN MEDICAL, INC. 510(k) NO: K041222(TRADITIONAL) ATTN: LINDA MORGAN PHONE NO : 972-245-2243 1601 WALLACE DR., SUITE 150 SE DECISION MADE: 14-OCT-04 CARROLLTON, TX 75006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IV ADMINISTRATION SETS WITH ULTRABLOCK UV-RESISTANT TUBING B. BRAUN MEDICAL, INC. 510(k) NO: K041490(TRADITIONAL) ATTN: JENNIFER A PUNG, PHONE NO : 610-266-0500 901 MARCON BLVD. SE DECISION MADE: 29-OCT-04 ALLENTOWN, PA 18109-9341 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT BARD ACCESS SYSTEMS, INC. 510(k) NO: K042445(TRADITIONAL) ATTN: CHARLES MORREALE PHONE NO : 801-595-5534 5425 WEST AMELIA EARHART DR. SE DECISION MADE: 19-OCT-04 SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: BAXJECT II BAXTER HEALTHCARE CORP. 510(k) NO: K042410(ABBREVIATED) ATTN: RON LAGERQUIST PHONE NO : 805-372-3064 ONE BAXTER WAY SE DECISION MADE: 08-OCT-04 WESTLAKE VILLAGE, CA 91362 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COULTER A T 5DIFF CAP PIERCE (CP) BECKMAN COULTER, INC. 510(k) NO: K042173(ABBREVIATED) ATTN: LOURDES COBA PHONE NO : 305-380-4079 11800 SW 147TH AVE. SE DECISION MADE: 12-OCT-04 MIAMI, FL 33196-2500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FREE T3 CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS BECKMAN COULTER, INC. 510(k) NO: K042651(TRADITIONAL) ATTN: VALYNDA MACHEN PHONE NO : 952-368-1383 1000 LAKE HAZELTINE DR. SE DECISION MADE: 05-OCT-04 CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO COULTER LH 500 HEMATOLOGY ANALYZER BECKMAN COULTER, INC. 510(k) NO: K042724(SPECIAL) ATTN: STAN SUGRUE PHONE NO : 305-380-4552 11800 S.W. 147TH AVE. SE DECISION MADE: 29-OCT-04 MAIL CODE 31-B06 510(k) SUMMARY AVAILABLE FROM FDA MIAMI, FL 33196-2500 DEVICE: BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE M BECTON DICKINSON 510(k) NO: K041478(TRADITIONAL) ATTN: JOHN SCHALAGO PHONE NO : 201-847-5663 1 BECTON DR. SE DECISION MADE: 28-OCT-04 FRANKLIN LAKES, NJ 07417-1880 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 1BD SOLOSHOT IX SYRINGE BECTON DICKINSON & CO. 510(k) NO: K042934(SPECIAL) ATTN: PETER ZURLO PHONE NO : 201-847-6447 1 BECTON DRIVE SE DECISION MADE: 28-OCT-04 FRANKLIN LAKES, NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTIMA MX BIEN-AIR SA SWITZERLAND 510(k) NO: K042759(TRADITIONAL) ATTN: ALAIN LEONETTI PHONE NO : +41 323 446464 LANGASSE 60, CASE POSTALE SE DECISION MADE: 20-OCT-04 BIENNE 6, SWITZERLAND CH-2500 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MODIFICATION TO SILHOUETTE IC OR SILHOUETTE; LASER-LOK SURFACE T BIO-LOK INTL., INC. 510(k) NO: K041136(TRADITIONAL) ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035 P.O. BOX 560 SE DECISION MADE: 22-OCT-04 STILLWATER, MN 55082 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAXAIR SURGICAL HELMET SYSTEM BIO-MEDICAL DEVICES, INC. 510(k) NO: K040485(TRADITIONAL) ATTN: NICK HERBERT PHONE NO : 949-752-9642 17171 DAIMLER AVE. SE DECISION MADE: 18-OCT-04 IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CONTROL, LEVEL 4, 5 BIO-RAD 510(k) NO: K042324(TRADITIONAL) ATTN: MARIA ZEBELLOS PHONE NO : 949-598-1200 9500 JERONIMO RD. SE DECISION MADE: 07-OCT-04 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL M BIO-RAD LABORATORIES, INC. 510(k) NO: K042336(TRADITIONAL) ATTN: MARIA ZEBALLOS PHONE NO : 949-598-1367 9500 JERONIMO RD. SE DECISION MADE: 14-OCT-04 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUI-HEME GLYCO A1C ASSAY BIODIAGNOSTIC INTL 510(k) NO: K031296(TRADITIONAL) ATTN: PAUL ANAND PHONE NO : 714-529-7797 615 NORTH BERRY ST. SE DECISION MADE: 15-OCT-04 # E 510(k) STATEMENT BREA, CA 92821 DEVICE: BIOMEDIX PADNET LAB BIOMEDIX, INC. 510(k) NO: K042616(TRADITIONAL) ATTN: WILLIAM ROGERS PHONE NO : 651-762-4010 4205 WHITE BEAR PKWY. SE DECISION MADE: 12-OCT-04 ST. PAUL, MN 55110 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ARTHROTEK MENISCAL HYBRID DEVICE BIOMET, INC. 510(k) NO: K041988(TRADITIONAL) ATTN: GARY BAKER PHONE NO : 574-267-6639 56 EAST BELL DR. SE DECISION MADE: 20-OCT-04 PO BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: MAESTRO TOTAL WRIST BIOMET, INC. 510(k) NO: K042032(TRADITIONAL) ATTN: PATRICIA SANDBORN BERES PHONE NO : 574-267-6639 56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 07-OCT-04 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: M2A MAGNUM SYSTEM BIOMET, INC. 510(k) NO: K042037(TRADITIONAL) ATTN: KACY ARNOLD PHONE NO : 574-267-6639 56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 01-OCT-04 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QC-BEADS BIOSCREEN INC. 510(k) NO: K042750(TRADITIONAL) ATTN: ALICE DEUTSCH PHONE NO : 212-260-6692 889 BROADWAY - SUITE 6A SE DECISION MADE: 29-OCT-04 NEW YORK, NY 10003 510(k) STATEMENT DEVICE: ERA 3000 PACING SYSTEM ANALYZER BIOTRONIK, INC. 510(k) NO: K042708(SPECIAL) ATTN: JON BRUMBAUGH PHONE NO : 888-345-0374 6024 JEAN RD. SE DECISION MADE: 20-OCT-04 LAKE OSWEGO, OR 97035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO BLACKSTONE MODULAR PEDICLE SCREW SYSTEM BLACKSTONE MEDICAL, INC. 510(k) NO: K042514(SPECIAL) ATTN: DEAN E CIPORKIN PHONE NO : 413-731-8711 90 BROOKSDALE DR. SE DECISION MADE: 07-OCT-04 SPRINGFIELD, MA 01104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000 BLEASE MEDICAL EQUIPMENT LTD. 510(k) NO: K041430(SPECIAL) ATTN: ARTHUR J WARD PHONE NO : 813-645-2855 962 ALLEGRO LN. SE DECISION MADE: 07-OCT-04 APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-1 BOSTON SCIENTIFIC CORP. 510(k) NO: K042539(SPECIAL) ATTN: JAMES LEATHLEY PHONE NO : 510-440-7836 47900 BAYSIDE PARKWAY SE DECISION MADE: 19-OCT-04 FREMONT, CA 94538-6515 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXCELSIOR 1018 AND SL-10 MICROCATHETERS BOSTON SCIENTIFIC CORP. 510(k) NO: K042568(SPECIAL) ATTN: VICTOR HAM PHONE NO : 510-440-7604 47900 BAYSIDE PARKWAY SE DECISION MADE: 15-OCT-04 FREMONT, CA 94538-6515 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDER BRAEMAR, INC. 510(k) NO: K042469(TRADITIONAL) ATTN: DARREN DERSHEM PHONE NO : 952-890-5135 11481 RUPP DR. SE DECISION MADE: 06-OCT-04 BURNSVILLE, MN 55337 510(k) STATEMENT DEVICE: VECTORVISION UNI-KNEE BRAINLAB AG 510(k) NO: K041899(SPECIAL) ATTN: RAINER BIRKENBACH PHONE NO : 49 89 9915680 AMMERTHALSTRASSE 8 SE DECISION MADE: 06-OCT-04 HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KOLIBRI IMAGE GUIDED SURGERY SYSTEM BRAINLAB AG 510(k) NO: K042391(TRADITIONAL) ATTN: JENS WITTE PHONE NO : 49 89 9915680 AMMERTHALSTRASSE 8 SE DECISION MADE: 19-OCT-04 HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IPLAN! BRAINLAB, AG 510(k) NO: K041703(TRADITIONAL) ATTN: RAINER BIRKENBACH PHONE NO : 498 999 15680 AMMERTHALSTRASSE 8 SE DECISION MADE: 22-OCT-04 HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: E-PAIN CARE BREG, INC. 510(k) NO: K041714(TRADITIONAL) ATTN: KATHLEEN BARBER PHONE NO : 760-599-5719 2611 COMMERCE WAY SE DECISION MADE: 01-OCT-04 VISTA, CA 92083 510(k) STATEMENT DEVICE: C-BOOT C-BOOT LTD. 510(k) NO: K041659(TRADITIONAL) ATTN: AVI ABRAHAM PHONE NO : 972 544 949699 8 MARVA STREET SE DECISION MADE: 28-OCT-04 CARMIEL, ISRAEL 21691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDEON COBRA CATHETER CARDEON CORP. 510(k) NO: K042156(TRADITIONAL) ATTN: JANE BEGGS PHONE NO : 408-517-2522 10600 NORTH TANTAU AVE. SE DECISION MADE: 06-OCT-04 CUPERTINO, CA 95014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASOSTASIS VASCULAR CLOSURE SYSTEM CARDIVA MEDICAL, INC. 510(k) NO: K041486(TRADITIONAL) ATTN: AUGUSTINE LIEN PHONE NO : 650-964-8900 2585 LEGHORN ST. SE DECISION MADE: 22-OCT-04 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALPHA METASUL 28MM AND 32MM ACETABULAR INSERTS, STANDARD AND HOO CENTERPULSE ORTHOPEDICS, INC. 510(k) NO: K033943(TRADITIONAL) ATTN: AUDREY SWEARINGEN PHONE NO : 512-432-9255 9900 SPECTRUM DR. SE DECISION MADE: 18-OCT-04 AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KARATS MULTIPURPOSE SOLUTION CIBA VISION CORPORATION 510(k) NO: K031753(TRADITIONAL) ATTN: STEVEN DOWDLEY PHONE NO : 678-415-3897 11460 JOHNS CREEK PKWY. SE DECISION MADE: 28-OCT-04 DULUTH, GA 30097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIO-CHEM ANALYZER, MODEL 100 CLINICAL ANALYSIS CORPORATION, INC510(k) NO: K040750(TRADITIONAL) ATTN: CHARLES MCBRAIRTY PHONE NO : 215-536-1137 2100 QUAKER POINTE DRIVE SE DECISION MADE: 28-OCT-04 QUAKERTOWN, PA 18951-2182 510(k) STATEMENT DEVICE: PERFUDROP AIR M-P WITH NEEDLE 20 G, MODEL 48451606 CLINICO 510(k) NO: K041919(ABBREVIATED) ATTN: REINHARD HOPF PHONE NO : 011 49 6621168480 5 ROBERT-KOCH-STRASSE SE DECISION MADE: 04-OCT-04 BAD HERSFELD, GERMANY D-36251 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CDX DIGITAL X-RAY IMAGING SYSTEM CNC IMAGING, INC. 510(k) NO: K042736(TRADITIONAL) ATTN: KORINA A AKHONDZADEH PHONE NO : 760-798-9642 1559 EDEN COURT SE DECISION MADE: 13-OCT-04 SAN ELIJO HILLS, CA 92078 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXAM-PACS COACTIV, LLC 510(k) NO: K042647(TRADITIONAL) ATTN: CARL ALLETTO PHONE NO : 940-300-8601 1100 LAKEVIEW BLVD SE DECISION MADE: 07-OCT-04 DENTON, TX 76208 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: IV ADMINISTRATION SET B400 SP CODAN US CORP. 510(k) NO: K042693(TRADITIONAL) ATTN: ROHIT PATEL PHONE NO : 714-545-2111 3511 WEST SUNFLOWER AVE. SE DECISION MADE: 21-OCT-04 SANTA ANA, CA 92704-6944 510(k) STATEMENT DEVICE: NP-2600 SERIES HARDCOPY PRINTERS CODONICS, INC. 510(k) NO: K042232(TRADITIONAL) ATTN: ALAN DESANTIS PHONE NO : 440-243-1198 17991 ENGLEWOOD DR. SE DECISION MADE: 05-OCT-04 MIDDLEBURG HEIGHTS, OH 44130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MENTAMOVE COLE & ASSOCIATES 510(k) NO: K040849(TRADITIONAL) ATTN: RICHARD O WOOD PHONE NO : 312-807-4364 70 W. MADISON ST. SE DECISION MADE: 01-OCT-04 SUITE 3300 510(k) SUMMARY AVAILABLE FROM FDA CHICAGO, IL 60602 DEVICE: INTRAUTERINE VENOGRAM NEEDLE SET COOK UROLOGICAL, INC. 510(k) NO: K041062(TRADITIONAL) ATTN: CINDY RUMPLE PHONE NO : 812-829-6500 1100 WEST MORGAN ST. SE DECISION MADE: 01-OCT-04 SPENCER, IN 47460 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZILVER 518 BILIARY STENT COOK, INC. 510(k) NO: K042518(SPECIAL) ATTN: LELAND KEYT PHONE NO : 800-346-2686 750 DANIELS WAY PO BX 489 SE DECISION MADE: 01-OCT-04 BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COOPER PROSTHETIC COOPERVISION, INC. 510(k) NO: K042435(TRADITIONAL) ATTN: BONNIE J TSMBAL PHONE NO : 585-264-3210 711 NORTH RD. SE DECISION MADE: 26-OCT-04 SCOTTSVILLE, NY 14546 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM CRYOVASCULAR SYSTEMS, INC. 510(k) NO: K042541(SPECIAL) ATTN: KIM TOMPKINS PHONE NO : 408-866-3203 160 KNOWLES DR. SE DECISION MADE: 12-OCT-04 LOS GATOS, CA 95032 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LSO PET/CT HIREZ 64 CTI PET SYSTEMS, INC. 510(k) NO: K042467(SPECIAL) ATTN: M. ALAINE MEDIO PHONE NO : 865-218-2703 810 INNOVATION DR. SE DECISION MADE: 01-OCT-04 KNOXVILLE, TN 37932-2571 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTICLEAR XL MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM CURELIGHT LTD 510(k) NO: K041994(TRADITIONAL) ATTN: JONATHAN S KAHN PHONE NO : 202-637-5794 555 THIRTEENTH STREET, N.W. SE DECISION MADE: 06-OCT-04 WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CUTERA TABLETOP AESTHETIC PRODUCT CUTERA, INC. 510(k) NO: K042165(TRADITIONAL) ATTN: KATHY MAYNOR PHONE NO : 415-657-5586 3240 BAYSHORE BLVD. SE DECISION MADE: 18-OCT-04 BRISBANE, CA 94005 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: 3 SERIES PHOTOTHERAPY CABINET DAAVLIN DISTRIBUTING CO. 510(k) NO: K042502(TRADITIONAL) ATTN: DAVID W SWANSON PHONE NO : 419-636-6304 205 WEST BEMENT ST. SE DECISION MADE: 14-OCT-04 BRYAN, OH 43506 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONTROL PLASMA N AND CONTROL PLASMA P DADE BEHRING, INC. 510(k) NO: K042209(TRADITIONAL) ATTN: DONNA A WOLF PHONE NO : 302-631-0384 514 GBC DR. SE DECISION MADE: 21-OCT-04 NEWARK, DE 19702 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMIT CAFFEINE ASSAY DADE BEHRING, INC. 510(k) NO: K042407(TRADITIONAL) ATTN: YUK-TING LEWIS PHONE NO : 302-631-7626 P.O. BOX 6101 SE DECISION MADE: 28-OCT-04 M/S 514 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: GE DATEX-OHMEDA S/5 NETWORK AND ICENTRAL '03, SALES REVISION 3.3 DATEX-OHMEDA 510(k) NO: K042771(SPECIAL) ATTN: JOEL KENT PHONE NO : 781-449-8685 86 PILGRIM RD. SE DECISION MADE: 15-OCT-04 NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE DATEX-OHMEDA ENGSTROM CARESTATION DATEX-OHMEDA, INC. 510(k) NO: K041775(TRADITIONAL) ATTN: DAN KOSEDNAR PHONE NO : 608-221-1551 PO BOX 7550 SE DECISION MADE: 26-OCT-04 MADISON, WI 53707 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GELATO PROPHYLAXIS PASTE DEEPAK PRODUCTS, INC. 510(k) NO: K042048(TRADITIONAL) ATTN: RICARDO A CARLES PHONE NO : 305-805-2216 5220 NW 72ND AVE., BAY #15 SE DECISION MADE: 26-OCT-04 MIAMI, FL 33166 510(k) STATEMENT DEVICE: HDL-EX SEIKEN ASSAY KIT DENKA SEIKEN CO., LTD. 510(k) NO: K041090(TRADITIONAL) ATTN: TOSHIMI MATSUNAGA PHONE NO : 812 504 27221 1-2-2, MINAMIHONCHO, SE DECISION MADE: 29-OCT-04 GOSEN CITY 510(k) SUMMARY AVAILABLE FROM FDA NIIGATA, JAPAN 959-1695 DEVICE: DYRACT CEM PLUS CEMENT DENTSPLY INTL. 510(k) NO: K041272(TRADITIONAL) ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511 221 WEST PHILADELPHIA STREET SE DECISION MADE: 18-OCT-04 SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA YORK, PA 17404 DEVICE: DORSAL INTRAMEDULLARY PLATE DEO VOLENTE ORTHOPAEDICS, LLC 510(k) NO: K042437(TRADITIONAL) ATTN: DINA L WEISSMAN, J.D. PHONE NO : 574-267-8828 P.O. BOX 83 SE DECISION MADE: 08-OCT-04 WARSAW, IN 46581 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMARTMIX PRE-FILLED MIXING SYSTEM DEPUY ORTHOPAEDICS, INC. 510(k) NO: K042591(SPECIAL) ATTN: TIFFANI ROGERS PHONE NO : 574-371-4927 700 ORTHOPAEDIC DR. SE DECISION MADE: 22-OCT-04 P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0988 DEVICE: SUMIT OCT SPINAL SYSTEM AND MOUNTAINEER OCT SPINAL SYSTEM DEPUY SPINE, INC. 510(k) NO: K042508(SPECIAL) ATTN: SHARON STAROWICZ PHONE NO : 508-828-2867 325 PARAMOUNT DR. SE DECISION MADE: 07-OCT-04 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROALBUMIN MULTI-CALIBRATOR SET DIAGNOSTIC CHEMICALS LTD. 510(k) NO: K042243(TRADITIONAL) ATTN: NANCY OLSCAMP PHONE NO : 902 566 1396 16 MCCARVILLE ST. SE DECISION MADE: 04-OCT-04 WEST ROYALTY INDUSTRIAL PARK 510(k) STATEMENT CHARLOTTETOWN, PRINCE EDWARD, CANADA C1E 2A6 DEVICE: AZURYT MODEL CLT 1401, CO2 SURGICAL LASER SYSTEM DIAMOND AGE SYSTEMS, INC. 510(k) NO: K042439(TRADITIONAL) ATTN: GEOFFREY D SWANK PHONE NO : 303-263-3307 3775 SOUTH LAUREL WAY SE DECISION MADE: 07-OCT-04 CHANDLER, AZ 85249 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DIAZYME SODIUM ENZYMATIC ASSAY DIAZYME LABORATORIES 510(k) NO: K042189(TRADITIONAL) ATTN: HUHAN TRAN PHONE NO : 858-455-4761 3550 GENERAL ATOMICS CT. SE DECISION MADE: 07-OCT-04 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIAZYME POTASSIUM ENZYMATIC ASSAY KIT DIAZYME LABORATORIES 510(k) NO: K042191(TRADITIONAL) ATTN: HUAN TRAN PHONE NO : 858-455-4761 3550 GENERAL ATOMICS CT. SE DECISION MADE: 29-OCT-04 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIAZYME GLYCATED SERUM PROTEIN ENZYMATIC ASSAY KIT DIAZYME LABORATORIES 510(k) NO: K042193(TRADITIONAL) ATTN: CHONG YUAN PHONE NO : 858-455-4761 3550 GENERAL ATOMICS CT. SE DECISION MADE: 29-OCT-04 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DRG SOFTRELEASE DOCTOR'S RESEARCH GROUP, INC. 510(k) NO: K041018(TRADITIONAL) ATTN: EDWARD H GOLDMAN PHONE NO : 860-283-1479 50 ALTAIR AVE. SE DECISION MADE: 18-OCT-04 PLYMOUTH, CT 06782 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFINITY GAMMA/GAMMAXL AND VISTA WITH VF5 DRAEGER MEDICAL SYSTEMS, INC. 510(k) NO: K042656(SPECIAL) ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500 16 ELECTRONICS AVE. SE DECISION MADE: 06-OCT-04 DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM DRAEGER MEDICAL, INC. 510(k) NO: K042419(TRADITIONAL) ATTN: MICHAEL A KELHART PHONE NO : 215-721-5400 3135 QUARRY RD. SE DECISION MADE: 08-OCT-04 TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CYBIRD LED CURING LIGHT DXM CO., LTD. 510(k) NO: K042703(TRADITIONAL) ATTN: CAROLANN KOTULA PHONE NO : 770-985-8203 55 NORTHERN BLVD. SE DECISION MADE: 12-OCT-04 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 11021 THIRD PARTY REVIEW DEVICE: EBI CAS SPINE SPACER SYSTEM EBI, L.P. 510(k) NO: K042268(SPECIAL) ATTN: FREDERIC TESTA PHONE NO : 973-299-9300 100 INTERPACE PKWY. SE DECISION MADE: 27-OCT-04 PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IQQA-CHEST SOFTWARE PACKAGE EDDA TECHNOLOGY, INC. 510(k) NO: K042408(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 P.O. BOX 7007 SE DECISION MADE: 08-OCT-04 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER ELA MEDICAL INC 510(k) NO: K042002(TRADITIONAL) ATTN: SUSAN OLIVE PHONE NO : 763-519-9400 2950 XENIUM LN. N. STE. 120 SE DECISION MADE: 20-OCT-04 PLYMOUTH, MN 55441 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LASEREX, MODEL LP4532 ELLEX MEDICAL PTY. LTD. 510(k) NO: K041598(TRADITIONAL) ATTN: KEVIN HOWARD PHONE NO : 618 810 45200 74 TO 86 GILBERT ST. SE DECISION MADE: 06-OCT-04 ADELAIDE, SOUTH AUSTRALIA, AUSTRAL510(k) STATEMENT DEVICE: ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM ENDIUS, INC. 510(k) NO: K041808(SPECIAL) ATTN: CHRISTINE KUNTZ-NASSIF PHONE NO : 508-643-0983 23 WEST BACON ST. SE DECISION MADE: 01-OCT-04 PLAINVILLE, MA 02762 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENSITE SYSTEM, MODEL EE3000 ENDOCARDIAL SOLUTIONS, INC. 510(k) NO: K042493(SPECIAL) ATTN: KAREN J MCKELVEY PHONE NO : 651-632-9454 1350 ENERGY LN., SUITE 110 SE DECISION MADE: 15-OCT-04 ST. PAUL, MN 55108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS ERBE USA, INC. 510(k) NO: K033421(ABBREVIATED) ATTN: JULIE STEPHENS PHONE NO : 678-513-0693 111 LAUREL RIDGE DRIVE SE DECISION MADE: 14-OCT-04 ALPHARETTA, GA 30004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: G-SCAN ESAOTE, S.P.A. 510(k) NO: K042236(TRADITIONAL) ATTN: CARRI GRAHAM PHONE NO : 317-849-1916 7992 CASTLEWAY DRIVE SE DECISION MADE: 04-OCT-04 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLUCOSE TOLERANCE BEVERAGE EVER SCIENTIFIC 510(k) NO: K042183(TRADITIONAL) ATTN: JAY REINHARDT PHONE NO : 610-209-1343 7 WETHERILL LANE SE DECISION MADE: 27-OCT-04 CHESTER SPRINGS, PA 19425 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXACTECH ACUMATCH A-SERIES & MCS CONSTRAINED ACETABULAR LINERS EXACTECH, INC. 510(k) NO: K040601(ABBREVIATED) ATTN: GARY MILLER PHONE NO : 352-377-1140 2320 N.W. 66TH CT. SE DECISION MADE: 04-OCT-04 GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXACTECH OPTETRAK UNICONDYLAR KNEE EXACTECH, INC. 510(k) NO: K040889(TRADITIONAL) ATTN: GARY MILLER PHONE NO : 352-377-1140 2320 N.W. 66TH CT. SE DECISION MADE: 01-OCT-04 GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXACTECH EQUINOXE SHOULDER SYSTEM EXACTECH, INC. 510(k) NO: K042021(TRADITIONAL) ATTN: GARY MILLER PHONE NO : 352-377-1140 2320 N.W. 66TH CT. SE DECISION MADE: 26-OCT-04 GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BALANCEBACK VNG SYSTEM FALL PREVENTION TECHNOLOGIES, LLC 510(k) NO: K042529(TRADITIONAL) ATTN: KEITH KRAVITZ PHONE NO : 561-995-8883 2300 NW CORPORATE BLVD. SE DECISION MADE: 06-OCT-04 SUITE 141 510(k) SUMMARY AVAILABLE FROM FDA BOCA RATON, FL 33431 THIRD PARTY REVIEW DEVICE: MAMMOTEST FISCHER IMAGING CORP. 510(k) NO: K042095(TRADITIONAL) ATTN: ROBERT G SCHUEPPERT PHONE NO : 303-254-2525 12300 NORTH GRANT ST. SE DECISION MADE: 29-OCT-04 DENVER, CO 80241-3120 510(k) STATEMENT DEVICE: TWINHEADS TH-103 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER FMD, LLC 510(k) NO: K042561(SPECIAL) ATTN: YOUSRY FARAGALLA PHONE NO : 703-880-4642 P.O. BOX 1500 SE DECISION MADE: 12-OCT-04 LORTON, VA 22199-1500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TITANIUM TELEGRAPH HUMERAL NAIL FOURNITURES HOSPITALIERES INDUSTRI510(k) NO: K042332(TRADITIONAL) ATTN: CHRISTINE QUENDEZ PHONE NO : 332 985 56895 ZI DE KERNEVEZ-6 RUE NOBEL SE DECISION MADE: 07-OCT-04 QUIMPER, FRANCE 29000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FRIADENT PLUS DENTAL IMPLANT SYSTEMS FRIADENT GMBH 510(k) NO: K040170(TRADITIONAL) ATTN: CAROL PATTERSON PHONE NO : 949-462-0900 21911 ERIE LN. SE DECISION MADE: 27-OCT-04 LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SEEDNET GOLD WITH RENAL KIT, MODEL FPRPR 3021, (RENAL KIT), FPRC GALIL MEDICAL LTD. 510(k) NO: K042667(SPECIAL) ATTN: JONATHAN S KAHN PHONE NO : 202-637-5794 555 THIRTEENTH STREET, N.W. SE DECISION MADE: 14-OCT-04 WASHINGTON, DC 20009 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS GAMBRO RENAL PRODUCTS 510(k) NO: K041005(ABBREVIATED) ATTN: THOMAS B DOWELL PHONE NO : 303-231-4094 10810 WEST COLLINS AVE. SE DECISION MADE: 07-OCT-04 LAKEWOOD, CO 80215 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MI PASTE GC AMERICA, INC. 510(k) NO: K042200(TRADITIONAL) ATTN: TERRY L JORITZ PHONE NO : 708-926-3105 3737 WEST 127TH ST. SE DECISION MADE: 20-OCT-04 ALSIP, IL 60803 510(k) STATEMENT DEVICE: CENTRICITY RADIOLOGY RA600/CENTRICITY CARDIOLOGY CA1000/CENTRICI GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K042525(TRADITIONAL) ATTN: CAROL ALLOIAN PHONE NO : 847-704-3060 800 BUSINESS CENTER DR. SE DECISION MADE: 01-OCT-04 MOUNT PROSPECT, IL 60056 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT GENERAL ATOMICS 510(k) NO: K042448(TRADITIONAL) ATTN: HUAN TRAN PHONE NO : 858-455-4761 3550 GENERAL ATOMICS COURT SE DECISION MADE: 29-OCT-04 SAN DIEGO, CA 92121 510(k) STATEMENT DEVICE: GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE GIVEN IMAGING LTD. 510(k) NO: K041149(TRADITIONAL) ATTN: SHOSH FRIEDMAN PHONE NO : 011 972 49097784 13 HAYETZIRA STREET SE DECISION MADE: 25-OCT-04 NEW INDUSTRIAL ZONE 510(k) SUMMARY AVAILABLE FROM FDA YOKNEAM, ISRAEL 20692 DEVICE: KELES FACEMASK GREAT LAKES ORTHODONTICS, LTD. 510(k) NO: K041718(TRADITIONAL) ATTN: DAVE GRAVER PHONE NO : 800-828-7626 200 COOPER AVE. SE DECISION MADE: 15-OCT-04 P.O. BOX 5111 510(k) SUMMARY AVAILABLE FROM FDA TONAWANDA, NY 14151-5111 DEVICE: BITECH BIPOLAR SCISSORS GUENTER BISSINGER MEDIZINTECHNIK G510(k) NO: K042077(TRADITIONAL) ATTN: FRANZ MENEAN PHONE NO : 49 746 399540 47 GRIESWEG SE DECISION MADE: 27-OCT-04 MUEHLHEIM, BADEN-WUERTTEMBERG, GER510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GYRUS PLASMACISION LAPAROSCOPIC SPATULA GYRUS MEDICAL, INC. 510(k) NO: K041633(TRADITIONAL) ATTN: DAVID E CHADWICK PHONE NO : 763-416-7239 6655 WEDGWOOD ROAD, SUITE 160 SE DECISION MADE: 22-OCT-04 MAPLE GROVE, MN 55311-3602 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GALILEO GOLD HAMILTON MEDICAL, INC. 510(k) NO: K040574(TRADITIONAL) ATTN: J. DAVID THOMPSON PHONE NO : 775-858-3200 P.O. BOX 30008 SE DECISION MADE: 27-OCT-04 RENO, NV 89520 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168 HEALTH & LIFE CO., LTD. 510(k) NO: K042802(SPECIAL) ATTN: PAUL HUNG PHONE NO : 886 2 82271300 9F, NO.186, JIAN YI ROAD SE DECISION MADE: 26-OCT-04 CHUNG HO CITY, TAIPEI, CHINA (TAIW510(k) STATEMENT DEVICE: ACU-STRAP MOTION SICKNESS BAND HEALTH ENT., INC. 510(k) NO: K041877(TRADITIONAL) ATTN: DANIEL J DILLON PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 08-OCT-04 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / HEIDELBERG ENGINEERING 510(k) NO: K042742(TRADITIONAL) ATTN: GERHARD ZINSER PHONE NO : +49 622 164630 GERHART-HAUPTMANN-STRASSE 30 SE DECISION MADE: 13-OCT-04 69221 DOSSENHEIM, GERMANY 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6 HEINZ KURZ GMBH MEDIZINTECHNIK 510(k) NO: K042503(TRADITIONAL) ATTN: DAGMAR MASER PHONE NO : 31 20 4289591 AMSTEL 320-I SE DECISION MADE: 01-OCT-04 AMSTERDAM, NETHERLANDS 1017 AP 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ETG-4000 OPTICAL TOPOGRAPHY SYSTEM HITACHI MEDICAL CORP. 510(k) NO: K042501(SPECIAL) ATTN: DOUG THISTLEWAITE PHONE NO : 330-425-1313 1959 SUMMIT COMMERCE PARK SE DECISION MADE: 12-OCT-04 TWINSBURG, OH 44087 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS HOLOGIC, INC. 510(k) NO: K042480(TRADITIONAL) ATTN: DANIEL F PHELAN PHONE NO : 781-999-7538 35 CROSBY DR. SE DECISION MADE: 29-OCT-04 BEDFORD, MA 01730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE HOSPIRA, INC. 510(k) NO: K042609(TRADITIONAL) ATTN: RAY SILKAITIS PHONE NO : 224-212-4897 275 N. FIELD DRIVE SE DECISION MADE: 06-OCT-04 LAKE FOREST, IL 60045-5045 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE HOSPIRA, INC. 510(k) NO: K042800(TRADITIONAL) ATTN: THOMAS KOZMA PHONE NO : 224-212-4803 275 N. FIELD DR., BLDG. H-2 SE DECISION MADE: 18-OCT-04 D-389 510(k) SUMMARY AVAILABLE FROM FDA LAKE FOREST, IL 60045-5045 THIRD PARTY REVIEW DEVICE: HOVEROUND MPV-5 POWERCHAIR HOVEROUND CORP. 510(k) NO: K042545(TRADITIONAL) ATTN: TONY DIGIOVANNI PHONE NO : 941-739-6200 2151 WHITFIELD INDUSTRIAL WAY SE DECISION MADE: 21-OCT-04 SARASOTA, FL 34243 510(k) STATEMENT DEVICE: T2 PROXIMAL HUMERAL NAIL HOWMEDICA OSTEONICS CORP. 510(k) NO: K042396(TRADITIONAL) ATTN: VIVIAN KELLY PHONE NO : 201-831-5581 325 CORPORATE DRIVE SE DECISION MADE: 08-OCT-04 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMPLANTMASTER I-DENT 510(k) NO: K042212(TRADITIONAL) ATTN: DAN LAOR PHONE NO : 972 545 311547 4 YOHANAN STREET, BOX 6402 SE DECISION MADE: 21-OCT-04 HOD HASHARON, ISRAEL 45241 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: NAVIGUS PASSIVE PROBE, MODEL NP-1000 IMAGE-GUIDED NEUROLOGICS, INC. 510(k) NO: K040334(TRADITIONAL) ATTN: DAVID M LEE PHONE NO : 321-309-8237 2290 EAU GALLIE BLVD. SE DECISION MADE: 04-OCT-04 MELBOURNE, FL 32935 510(k) STATEMENT DEVICE: IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA IMMCO DIAGNOSTICS, INC. 510(k) NO: K041102(TRADITIONAL) ATTN: KEVIN J LAWSON PHONE NO : 716-691-0091 60 PINEVIEW DR. SE DECISION MADE: 26-OCT-04 BUFFALO, NY 14228-2120 510(k) STATEMENT DEVICE: IDI-MRSA ASSAY INFECTIO DIAGNOSTIC (I.D.I.) INC. 510(k) NO: K042357(SPECIAL) ATTN: JUDITH SMITH PHONE NO : 410-592-2060 13801 ECK ROAD SE DECISION MADE: 22-OCT-04 HYDES, MD 21082 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXCELLA-M SPINAL SYSTEM INNOVASIS, INC. 510(k) NO: K042143(TRADITIONAL) ATTN: BRENT A FELIX PHONE NO : 801-557-1445 997 EAST 3900 SOUTH SE DECISION MADE: 07-OCT-04 SUITE 103 510(k) SUMMARY AVAILABLE FROM FDA SALT LAKE CITY, UT 84124 DEVICE: EQUI-FLOW VALVE AND SHUNT SYSTEM INTEGRA NEUROSCIENCES IMPLANTS S.A510(k) NO: K042558(TRADITIONAL) ATTN: JUDITH O'GRADY PHONE NO : 609-936-2311 311 ENTERPRISE DRIVE SE DECISION MADE: 06-OCT-04 PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTEGRATED PATIENT MONITORING SYSTEM INVIVO RESEARCH, INC. 510(k) NO: K041918(TRADITIONAL) ATTN: NEIL BATTISTE PHONE NO : 800-331-3220 12601 RESEARCH PKWY. SE DECISION MADE: 15-OCT-04 ORLANDO, FL 32826 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 60 ISOPURE CORP. 510(k) NO: K041163(TRADITIONAL) ATTN: KEVIN GILLESPIE PHONE NO : 129 CITIZENS BLVD. SE DECISION MADE: 07-OCT-04 SIMPSONVILLE, KY 40067 510(k) STATEMENT DEVICE: OSSATURA DENTAL ISOTIS ORTHOBIOLOGICS, INC 510(k) NO: K042706(TRADITIONAL) ATTN: PAUL DONER PHONE NO : 949-855-7168 2 GOODYEAR, SUITE B SE DECISION MADE: 20-OCT-04 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CROMAX HIGH SPEED TURBINE HANDPIECE J.R. MEDICAL TECHNOLOGIES, INC. 510(k) NO: K041755(TRADITIONAL) ATTN: J. HARVEY KNAUSS PHONE NO : 832-285-9423 11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 22-OCT-04 HOUSTON, TX 77071 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COLLAGEN-ORC ANTIMICROBIAL MATRIX JOHNSON & JOHNSON MEDICAL, LTD. 510(k) NO: K033523(TRADITIONAL) ATTN: JOHN D PAULSON PHONE NO : 908-218-2887 ROUTE 22 WEST SE DECISION MADE: 21-OCT-04 P.O. BOX 151 510(k) SUMMARY AVAILABLE FROM FDA SOMERVILLE, NJ 08876 DEVICE: FURLONG H-AC TOTAL HIP REPLACEMENT SYSTEM JRI MANUFACTURING LTD 510(k) NO: K041353(TRADITIONAL) ATTN: E.J. SMITH PHONE NO : 410-451-0639 P.O. BOX 4341 SE DECISION MADE: 08-OCT-04 CROFTON, MD 21114 510(k) STATEMENT DEVICE: SCB/VALLEYLAB FORCE FX INTERFACE UNIT KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K041912(TRADITIONAL) ATTN: SUSIE S CHEN PHONE NO : 310-348-4201 600 CORPORATE POINTE DRIVE SE DECISION MADE: 25-OCT-04 CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KLIMAMED THERMAL BLANKETS, INCLUDING ARM SHOULDER WEST THERMAL B KLIMAMED TECHNOLOGIE MEDIZINGERATE510(k) NO: K031728(TRADITIONAL) ATTN: JAY MANSOUR PHONE NO : 770-777-4146 1308 MORNINGSIDE PARK DR. SE DECISION MADE: 12-OCT-04 ALPHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KLS MARTIN DRILL-FREE MMF SCREW KLS-MARTIN L.P. 510(k) NO: K042573(TRADITIONAL) ATTN: JENNIFER DAMATO PHONE NO : 904-641-7746 1239-1 ST. JOHN'S IND. PKWY. SE DECISION MADE: 18-OCT-04 SOUTH 510(k) SUMMARY AVAILABLE FROM FDA JACKSONVILLE, FL 32246 DEVICE: STELLAR 404 MONITORING SYSTEM LARSEN & TOUBRO LIMITED 510(k) NO: K042560(TRADITIONAL) ATTN: HARRY GUGNANI PHONE NO : 847-303-3906 1821 WALDEN OFFICE SQUARE SE DECISION MADE: 06-OCT-04 SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA SCHAUMBURG, IL 60173 THIRD PARTY REVIEW DEVICE: BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS LINVATEC BIOMATERIALS, LTD. 510(k) NO: K042517(SPECIAL) ATTN: TUIJA ANNALA PHONE NO : 358 3 3165600 HERMIANKATU 6-8L SE DECISION MADE: 08-OCT-04 TAMPERE, FINLAND 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VALIDATE LIPOPROTEIN CALIBRATION VERIFICATION TEST SET, MODEL 50 MAINE STANDARDS CO. 510(k) NO: K041975(TRADITIONAL) ATTN: CHRISTINE BEACH PHONE NO : 207-892-1300 765 ROOSEVELT TRAIL SE DECISION MADE: 15-OCT-04 WINDHAM, ME 04062-5365 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRANSDERM IONTO SYSTEM, MK 2 MATTIOLI ENGINEERING CORP. 510(k) NO: K042590(TRADITIONAL) ATTN: MELISSA MAHALL PHONE NO : 301-623-2500 11800 BALTIMORE AVENUE SE DECISION MADE: 14-OCT-04 SUITE 105 510(k) SUMMARY AVAILABLE FROM FDA BELTSVILLE, MD 20705 DEVICE: COLON CAR 1.2 MEDICSIGHT 510(k) NO: K042674(SPECIAL) ATTN: CAROL MACDONALD PHONE NO : 440 207 5985351 46 BERKELEY SQUARE SE DECISION MADE: 19-OCT-04 LONDON, UNITED KINGDOM W 1J 5AT 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RSA-CMS MEDIS MEDICAL IMAGING SYSTEMS, B.V510(k) NO: K042383(TRADITIONAL) ATTN: J.I. HOLLANDER PHONE NO : 31 71 5223244 SCHUTTERSVELD 9 SE DECISION MADE: 20-OCT-04 LEIDEN, NETHERLANDS 2316 XG 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE FUGO BLADE FOR GLAUCOMA MEDISURG LTD. 510(k) NO: K041019(TRADITIONAL) ATTN: RICHARD J FUGO PHONE NO : 610-277-3937 100 WEST FORNANCE ST. SE DECISION MADE: 08-OCT-04 THE FUGO BUILDING 510(k) SUMMARY AVAILABLE FROM FDA NORRISTOWN, PA 19401 DEVICE: MODIFICATION TO MEDLINE STRIDER MIDI 3 MEDLINE INDUSTRIES, INC. 510(k) NO: K042763(SPECIAL) ATTN: ANDREA HAFERKAMP PHONE NO : 847-837-2759 ONE MEDLINE PLACE SE DECISION MADE: 07-OCT-04 MUNDELEIN, IL 60060 510(k) STATEMENT DEVICE: MEDLINE STRIDER MIDI 4 MEDLINE INDUSTRIES, INC. 510(k) NO: K042764(SPECIAL) ATTN: MARGARET STEPHENS PHONE NO : 847-949-2277 ONE MEDLINE PLACE SE DECISION MADE: 08-OCT-04 MUNDELEIN, IL 60060 510(k) STATEMENT DEVICE: PS MEDICAL STRATA II VALVE MEDTRONIC NEUROSURGERY 510(k) NO: K042465(SPECIAL) ATTN: JEFFREY HENDERSON PHONE NO : 805-968-1546 125 CREMONA DR. SE DECISION MADE: 19-OCT-04 GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K042498(SPECIAL) ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 07-OCT-04 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORION ANTERIOR CERVICAL PLATING SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K042499(SPECIAL) ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 07-OCT-04 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K042524(SPECIAL) ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 08-OCT-04 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K042402(SPECIAL) ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PL. SE DECISION MADE: 01-OCT-04 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO EQUATION FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K042453(SPECIAL) ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PL. SE DECISION MADE: 07-OCT-04 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20 MEDTRONIC, INC. 510(k) NO: K042070(SPECIAL) ATTN: DAWN STENSTROM PHONE NO : 763-391-9604 7611 NORTHLAND DR. SE DECISION MADE: 01-OCT-04 MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEPARINASE HR ACT CONTROL, MODEL 550-12 MEDTRONIC, INC. 510(k) NO: K042175(SPECIAL) ATTN: DAWN STENSTROM PHONE NO : 763-391-9604 7611 NORTHLAND DR. SE DECISION MADE: 18-OCT-04 MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PURPLE/BLACK HEPARIN ASSAY CONTROL MEDTRONIC, INC. 510(k) NO: K042206(SPECIAL) ATTN: DAWN STENSTROM PHONE NO : 763-391-9604 7611 NORTHLAND DR. SE DECISION MADE: 18-OCT-04 MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEGA PURE CART MEGA SERVICES 510(k) NO: K031832(TRADITIONAL) ATTN: ROBERT OLIVER PHONE NO : 210-945-8448 106 LOST MEADOWS DRIVE SE DECISION MADE: 20-OCT-04 CIBOLO, TX 78108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MENTOR GENESIS PENILE PROSTHESIS MENTOR CORP. 510(k) NO: K040959(TRADITIONAL) ATTN: DONNA A CRAWFORD PHONE NO : 805-879-6304 201 MENTOR DR. SE DECISION MADE: 29-OCT-04 SANTA BARBARA, CA 93111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EAR THERMOMETER MODELS ST61, ST62, ST63, ST64, AND ST65 MESURE TECHNOLOGY CO.,LTD. 510(k) NO: K042627(SPECIAL) ATTN: JOHN CHEN PHONE NO : 886 285 122747 7F,86,SEC.1, KWANG FU ROAD SE DECISION MADE: 18-OCT-04 SAN CHUNG CITY, CHINA (TAIWAN) 241510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTO THERM 390, MODEL ME 390 METTLER ELECTRONICS CORP. 510(k) NO: K042554(ABBREVIATED) ATTN: ROBERT E FLEMING PHONE NO : 800-854-9305 1333 SOUTH CLAUDINA ST. SE DECISION MADE: 08-OCT-04 ANAHEIM, CA 92805 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BAXTER DUPLOTIP SURGICAL SEALANT APPLICATOR MICROMEDICS, INC. 510(k) NO: K033589(TRADITIONAL) ATTN: CHARLES K GROTE PHONE NO : 651-452-1977 1285 CORPORATE CENTER DR., SE DECISION MADE: 04-OCT-04 #150 510(k) STATEMENT EAGAN, MN 55121 DEVICE: MB 105 MILLENNIUM BLADES MILLENNIUM BIOMEDICAL, INC. 510(k) NO: K041110(TRADITIONAL) ATTN: JERRY KAENI PHONE NO : 909-621-7646 360 EAST BONITA AVE. SE DECISION MADE: 13-OCT-04 POMONA, CA 91767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EASYPASS US Y-CONNECTOR HEMOSTATIC VALVE MILLIMED A/S 510(k) NO: K042060(TRADITIONAL) ATTN: JUDITH DANIELSON PHONE NO : 360-904-6512 1327 BLUEGRASS WAY SE DECISION MADE: 06-OCT-04 GAMBRILLS, MD 21054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NAI TECH PRODUCTS MEDICAL DIGITAL RECORDER NAI TECHNOLOGY PRODUCTS 510(k) NO: K042484(TRADITIONAL) ATTN: ROBERT E JOHNSON PHONE NO : 909-946-0099 1342-D NORTH BENSON AVENUE SE DECISION MADE: 20-OCT-04 UPLAND, CA 91786 510(k) STATEMENT DEVICE: SILICONE BLOCK NATIONAL MEDICAL DEVICES, INC. 510(k) NO: K042380(TRADITIONAL) ATTN: SHERRY J NULL PHONE NO : 406-961-0102 8500 WILSHIRE BLVD. SE DECISION MADE: 25-OCT-04 SUITE 707 510(k) STATEMENT BEVERLY HILLS, CA 90211 DEVICE: CAP-ONE, MODEL TG-920P NIHON KOHDEN AMERICA, INC. 510(k) NO: K040875(TRADITIONAL) ATTN: SERRAH NAMINI PHONE NO : 949-580-1555 90 ICON ST. SE DECISION MADE: 15-OCT-04 FOOTHILL RANCH, CA 92610-1601 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HAND STC, MODEL 60MM NITI MEDICAL TECHNOLOGIES LTD. 510(k) NO: K042492(TRADITIONAL) ATTN: ORLY MAOR PHONE NO : 972 9 8650610 1 HATZORAN ST. SE DECISION MADE: 19-OCT-04 P.O. BOX 8634 510(k) SUMMARY AVAILABLE FROM FDA NETANYA, ISRAEL 42506 DEVICE: PROCERA ABUTMENT BRANEMARK, MODELS 10-4001, 10-4004, 10-5001, 10 NOBEL BIOCARE USA, INC. 510(k) NO: K042658(TRADITIONAL) ATTN: ELIZABETH J MASON PHONE NO : 714-282-4800 22715 SAVI RANCH PKWY. SE DECISION MADE: 20-OCT-04 YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CENTURION SES EPIKERATOME NORWOOD ABBEY , LTD. 510(k) NO: K042810(SPECIAL) ATTN: PAUL CLARK PHONE NO : 613 978 27308 63 WELLS RD. SE DECISION MADE: 28-OCT-04 CHELSEA HGTS., VICTORIA, AUSTRALIA510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM NOVUS MONITORING LTD 510(k) NO: K042728(TRADITIONAL) ATTN: JUDITH E GRADY PHONE NO : 609-936-2311 311 ENTERPRISE DRIVE SE DECISION MADE: 22-OCT-04 PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUVASIVE MAXCESS LIGHT GUIDE NUVASIVE, INC. 510(k) NO: K042034(TRADITIONAL) ATTN: LAETITIA COUSIN PHONE NO : 858-527-1918 10065 OLD GROVE RD. SE DECISION MADE: 26-OCT-04 SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PANORAMIC 200A OPTOS PLC 510(k) NO: K042001(TRADITIONAL) ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5813 555 THIRTEENTH ST. N.W. SE DECISION MADE: 07-OCT-04 COLUMBIA SQUARE 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20004-1109 DEVICE: OPUS SPEEDSTITCH SUTURE DEVICE OPUS MEDICAL, INC. 510(k) NO: K042031(TRADITIONAL) ATTN: LAURA N KASPEROWICZ PHONE NO : 949-234-0400 27127 CALLE ARROYO, SUITE 1924 SE DECISION MADE: 19-OCT-04 SAN JUAN CAPISTRANO, CA 92675 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, ORTHO-CLINICAL DIAGNOSTICS 510(k) NO: K042494(TRADITIONAL) ATTN: DARLENE J PHILLIPS PHONE NO : 585-453-4253 100 INDIGO CREEK DR. SE DECISION MADE: 19-OCT-04 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K042006(TRADITIONAL) ATTN: DARLENE J PHILLIPS PHONE NO : 585-453-4253 100 INDIGO CREEK DR. SE DECISION MADE: 28-OCT-04 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSSAPLAST ORTHO, O.5ML, MODEL# 221 900, OSSAPLAST ORTHO, 1.0ML, OSSACUR AG 510(k) NO: K042305(ABBREVIATED) ATTN: KRISTI KISTNER PHONE NO : 805-682-8685 975 VERONICS SPRINGS ROAD SE DECISION MADE: 21-OCT-04 SANTA BARBARA, CA 93105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWERED WHEELCHAIR, MODEL B-500 OTTO BOCK HEALTH CARE, LP 510(k) NO: K041208(TRADITIONAL) ATTN: BOB CLARKE PHONE NO : 763-489-5105 2 CARLSON PWY. STE. 100 SE DECISION MADE: 01-OCT-04 MINNEAPOLIS, MN 55447-4467 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWERED WHEELCHAIR, MODEL B-600 OTTO BOCK HEALTH CARE, LP 510(k) NO: K041210(TRADITIONAL) ATTN: BOB CLARKE PHONE NO : 763-489-5105 2 CARLSON PWY. STE. 100 SE DECISION MADE: 01-OCT-04 MINNEAPOLIS, MN 55447-4467 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWERED WHEELCHAIR, MODEL C-1000 OTTO BOCK HEALTH CARE, LP 510(k) NO: K041211(TRADITIONAL) ATTN: BOB CLARKE PHONE NO : 763-489-5105 2 CARLSON PWY. STE. 100 SE DECISION MADE: 01-OCT-04 MINNEAPOLIS, MN 55447-4467 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WEST NILE VIRUS IGA INDIRECT ELISA PANBIO LIMITED 510(k) NO: K041068(TRADITIONAL) ATTN: CRAIG BREADMORE PHONE NO : 617 335 71177 116 LUTWYCHE RD. SE DECISION MADE: 20-OCT-04 WINDSOR, BRISBANE, AUSTRALIA 4030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PASCO MIC AND MIC/ID PANELS PASCO LABORATORIES, INC. 510(k) NO: K042331(TRADITIONAL) ATTN: LINDA K DILLON PHONE NO : 303-390-3240 12750 WEST 42ND AVE. SE DECISION MADE: 07-OCT-04 WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ISC-1000 PENTAX CONFOCAL LASER SYSTEM PENTAX MEDICAL COMPANY 510(k) NO: K042740(TRADITIONAL) ATTN: PAUL SILVA PHONE NO : 201-391-0932 102 CHESTNUT RIDGE ROAD SE DECISION MADE: 19-OCT-04 MONTVALE, NJ 07645 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: EC-3870CILK, CONFOCAL VIDEO COLONOSCOPE PENTAX MEDICAL COMPANY 510(k) NO: K042741(TRADITIONAL) ATTN: PAUL SILVA PHONE NO : 201-391-0932 102 CHESTNUT RIDGE ROAD SE DECISION MADE: 19-OCT-04 MONTVALE, NJ 07645 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PRACTIX CONVENIO PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K042368(ABBREVIATED) ATTN: LYNN HARMER PHONE NO : 425-487-7312 22100 BOTHELL EVERETT HIGHWAY SE DECISION MADE: 04-OCT-04 BOTHELL, WA 98021-8431 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C-PET PLUS IMAGING SYSTEM PHILIPS MEDICAL SYSTEMS(CLEVELAND)510(k) NO: K042839(TRADITIONAL) ATTN: RAE ANN FARROW PHONE NO : 440-483-2647 595 MINER RD. SE DECISION MADE: 29-OCT-04 CLEVELAND, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K042306(ABBREVIATED) ATTN: EGON PFEIL PHONE NO : 49 703 14631926 HEWLETT-PACKARD STR.2 SE DECISION MADE: 15-OCT-04 BOEBLINGEN, GERMANY D 71034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHILIPS IU22 ULTRASOUND SYSTEM PHILIPS ULTRASOUND, INC. 510(k) NO: K042540(TRADITIONAL) ATTN: LYNN HARMER PHONE NO : 425-487-7312 2722 S. FAIRVIEW SE DECISION MADE: 04-OCT-04 SANTA ANA, CA 92704 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: XTRAC XL, MODEL AL8000 PHOTO MEDEX, INC. 510(k) NO: K041943(TRADITIONAL) ATTN: BOB ROSE PHONE NO : 760-602-3300 2431 IMPALA DR. SE DECISION MADE: 14-OCT-04 CARLSBAD, CA 92008-7227 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLYMEDCO OC AUTO MICRO FOB TEST POLYMEDCO, INC. 510(k) NO: K041408(TRADITIONAL) ATTN: HELEN LANDICHO PHONE NO : 425-814-1514 510 FURNACE DOCK RD. SE DECISION MADE: 21-OCT-04 CORTLANDT MANOR, NY 10567 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRECISION LIQUID OXYGEN SYSTEM PRECISION MEDICAL, INC. 510(k) NO: K041122(TRADITIONAL) ATTN: JAMES PARKER PHONE NO : 610-262-6090 300 HELD DR. SE DECISION MADE: 04-OCT-04 NORTHAMPTON, PA 18067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LITESTREAM 500E PRIDE MOBILITY PRODUCTS CORP. 510(k) NO: K042444(TRADITIONAL) ATTN: THOMAS SCHAPPERT PHONE NO : 570-655-5574 182 SUSQUEHANNA AVE. SE DECISION MADE: 21-OCT-04 EXETER, PA 18643 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JAZZY 600 PRIDE MOBILITY PRODUCTS CORP. 510(k) NO: K042612(SPECIAL) ATTN: THOMAS J SCHAPPERT PHONE NO : 570-655-5574 182 SUSQUEHANNA AVE. SE DECISION MADE: 06-OCT-04 EXETER, PA 18643 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROMEDICAL SURGICAL MAYO STAND COVERS, BAND BAGS, TABLE COVERS A PROMEDICAL PRODUCTS CO., LTD. 510(k) NO: K042137(TRADITIONAL) ATTN: BOYD HARRIS PHONE NO : 662-312-0898 125 CLEMENTS AVE. SE DECISION MADE: 05-OCT-04 STARKVILLE, MS 39759 510(k) STATEMENT DEVICE: QRS-CARD CARDIOLOGY SUITE PULSE BIOMEDICAL, INC. 510(k) NO: K042799(TRADITIONAL) ATTN: SALEEM HASAN PHONE NO : 610-666-5510 935 SOUTH TROOPER RD. SE DECISION MADE: 22-OCT-04 NORRISTOWN, PA 19403 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: QUILL SYNTHETIC ABSORBABLE BARBED SUTURE QUILL MEDICAL, INC. 510(k) NO: K042075(TRADITIONAL) ATTN: JOHN F SCHAEFER PHONE NO : 201-818-6777 1600 STEWART AVE. SE DECISION MADE: 26-OCT-04 WESTBURY, NY 11590 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBE RADIANT MEDICAL 510(k) NO: K042388(TRADITIONAL) ATTN: ANDREW CLEELAND PHONE NO : 650-298-0733 250 CHESAPEAKE DR. SE DECISION MADE: 28-OCT-04 REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABL800 FLEX RADIOMETER MEDICAL APS 510(k) NO: K041874(TRADITIONAL) ATTN: LENE M MARNAES PHONE NO : 45 382 73827 AKANDEVEJ 21 SE DECISION MADE: 08-OCT-04 BRONSHOJ, DENMARK DK-2700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IPACS CARDIO REAL TIME IMAGE INC. 510(k) NO: K042781(TRADITIONAL) ATTN: CARL ALLETTO PHONE NO : 904-300-8601 1600 MANCHESTER WAY SE DECISION MADE: 19-OCT-04 CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ATP (AUTO NON-CONTACT TONOMETER/PACHYMETER) REICHERT INC. 510(k) NO: K042831(TRADITIONAL) ATTN: FRANK J DREXELIUS PHONE NO : 716-686-4548 3374 WALDEN AVE. SE DECISION MADE: 28-OCT-04 DEPEW, NY 14043 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: MIRAGE SWIFT RESMED LTD. 510(k) NO: K042403(TRADITIONAL) ATTN: DAVID D'CRUZ PHONE NO : 858-746-2238 14040 DANIELSON ST. SE DECISION MADE: 08-OCT-04 POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS RESPIRONICS NEW JERSEY, INC. 510(k) NO: K042655(TRADITIONAL) ATTN: LAUREN ZIEGLER PHONE NO : 973-571-2608 41 CANFIELD RD. SE DECISION MADE: 13-OCT-04 CEDAR GROVE, NJ 07009-1201 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ANTI-SNORING/SLEEP APNEA DEVICE RJ & VK BIRD PTY LTD. 510(k) NO: K042161(TRADITIONAL) ATTN: JONATHON BIRD PHONE NO : 011 613 96909898 25 MILLS STREET SE DECISION MADE: 27-OCT-04 MIDDLE PARK, VICTORIA, AUSTRALIA 3510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX ROCHE DIAGNOSTICS CORP. 510(k) NO: K042485(TRADITIONAL) ATTN: THERESA M AMBROSE PHONE NO : 317-521-3723 9115 HAGUE RD. SE DECISION MADE: 29-OCT-04 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOMETRIAL SAMPLING SYRINGE ROCKET MEDICAL PLC 510(k) NO: K040189(TRADITIONAL) ATTN: R. KEEN PHONE NO : 203-329-2700 1151 HOPE ST. SE DECISION MADE: 04-OCT-04 STAMFORD, CT 06907 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SLEEPSENSE SLEEP SENSORS S.L.P. LTD. 510(k) NO: K042253(TRADITIONAL) ATTN: NOAM HADAS PHONE NO : 972 3 5371281 18 HAZFIRA ST. SE DECISION MADE: 06-OCT-04 TEL-AVIV, ISRAEL 67779 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM SAFETY SYRINGES, INC. 510(k) NO: K042712(SPECIAL) ATTN: THOMAS L HALL PHONE NO : 760-918-9908 1939 PALOMAR OAKS WAY, SUITE A SE DECISION MADE: 15-OCT-04 CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LS FAMILY OF CO2 LASERS INCLUDING: LS-15 LASER SYSTEM (15 WATT) SANDSTONE MEDICAL TECHNOLOGIES, LL510(k) NO: K040563(TRADITIONAL) ATTN: CONNIE WHITE HOY PHONE NO : 530-666-7616 908 STETSON STREET SE DECISION MADE: 08-OCT-04 WOODLAND, CA 95776 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VARICES NEEDLE SCANDIMED. A.S. 510(k) NO: K031238(TRADITIONAL) ATTN: COURTNEY SMITH PHONE NO : 610-539-9300 280 GODSHALL RD SE DECISION MADE: 04-OCT-04 COLLEGEVILLE, PA 19426 510(k) STATEMENT DEVICE: SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEM SCANDIUS BIOMEDICAL, INC. 510(k) NO: K041961(TRADITIONAL) ATTN: ERIC BANNON PHONE NO : 978-486-4088 11A BEAVER BROOK ROAD SE DECISION MADE: 20-OCT-04 LITTLETON, MA 01460 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SELECT FABRICATORS, INC., AGMED TEX WOUND DRESSING SELECT FABRICATORS, INC. 510(k) NO: K040518(TRADITIONAL) ATTN: JOSEPH M AZARY PHONE NO : 203-944-9320 P.O. BOX 2156 SE DECISION MADE: 27-OCT-04 HUNTINGTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLARITY FUSION SHARED P.E.T. IMAGING, LLC 510(k) NO: K042692(SPECIAL) ATTN: RUSS PAGANO PHONE NO : 202-546-1262 710 A STREET, NE SE DECISION MADE: 07-OCT-04 WASHINGTON, DC 20002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHIAN JIA MEEI DIGATAL PWN TENS, MODEL YW-6000/UC-332/UC-330/ST- SHIAN JIA MEEI ENTERPRISE CO., LTD510(k) NO: K040311(TRADITIONAL) ATTN: JENNIFER REICH PHONE NO : 928-773-9488 3892 SOUTH AMERICA WEST TRAIL SE DECISION MADE: 01-OCT-04 FLAGGSTAF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY SIEMENS AG, MEDICAL SOLUTIONS 510(k) NO: K042605(SPECIAL) ATTN: RUDIGER KORNER PHONE NO : 499 191 189355 HENKESTRASSE 127 SE DECISION MADE: 08-OCT-04 ERLANGEN, GERMANY 91052 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SIENET COSMOS (VERSION V15A) SIEMENS AG, MEDICAL SOLUTIONS 510(k) NO: K042832(TRADITIONAL) ATTN: EVA REITER PHONE NO : +49 913 1842680 HENKESTRASSE 127 SE DECISION MADE: 28-OCT-04 ERLANGEN, GERMANY D-91052 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ACUSON ACUNAV 8F ULTRASOUND CATHETER SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K042593(SPECIAL) ATTN: ISKRA MARKOVIC PHONE NO : 650-694-5004 1230 SHOREBIRD WAY SE DECISION MADE: 15-OCT-04 P O BOX 7393 510(k) SUMMARY AVAILABLE FROM FDA MOUNTAIN VIEW, CA 94039-7393 DEVICE: MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K042770(TRADITIONAL) ATTN: PATRICK LYNCH PHONE NO : 425-557-1825 22010 S.E. 51ST ST. SE DECISION MADE: 20-OCT-04 ISSAQUAH, WA 98029 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K042833(TRADITIONAL) ATTN: PATRICK J LYNCH PHONE NO : 425-557-1825 22010 S.E. 51ST ST. SE DECISION MADE: 27-OCT-04 ISSAQUAH, WA 98029 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ARCADIS ORDIC (AVAILABLE WITH OPTIONS 3D AND 3D NAVIGATION INTER SIEMENS MEDICAL SOLUTIONS, INC. 510(k) NO: K042793(SPECIAL) ATTN: DEBBIE PEACOCK PHONE NO : 610-448-1773 51 VALLEY STREAM PARKWAY SE DECISION MADE: 29-OCT-04 E-50 510(k) SUMMARY AVAILABLE FROM FDA MALVERN, PA 19355 DEVICE: DYNACT SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K042646(SPECIAL) ATTN: ANA LADINO PHONE NO : 610-448-1785 51 VALLEY STREAM PARKWAY SE DECISION MADE: 19-OCT-04 MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IUR RECIPROCATING MORCELLATOR MODEL # 7210517 SMITH & NEPHEW, INC. 510(k) NO: K041774(TRADITIONAL) ATTN: JANICE HASELTON PHONE NO : 978-749-1494 150 MINUTEMAN ROAD SE DECISION MADE: 07-OCT-04 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IIIZAROV PULLEY SYSTEM SMITH & NEPHEW, INC. 510(k) NO: K042436(TRADITIONAL) ATTN: JOHN REABE PHONE NO : 901-399-6670 1450 E. BROOKS RD. SE DECISION MADE: 07-OCT-04 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEO 90 INFUSION SET SMITHS MEDICAL MD, INC. 510(k) NO: K042172(TRADITIONAL) ATTN: DAVID H SHORT PHONE NO : 651-628-7240 1265 GREY FOX ROAD SE DECISION MADE: 07-OCT-04 ST. PAUL, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONOSCAPE ULTRASOUND SYSTEM SSI-1000/SSI-5000 SONOSCAPE COMPANY LIMITED 510(k) NO: K042369(TRADITIONAL) ATTN: BOB LEIKER PHONE NO : 925-556-1302 7263 CRONIN CIRCLE SE DECISION MADE: 20-OCT-04 DUBLIN, CA 94568 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY STANBIO LABORATORY 510(k) NO: K041155(TRADITIONAL) ATTN: ADAOBI OGUCHI PHONE NO : 830-249-0772 1261 NORTH MAIN ST. SE DECISION MADE: 14-OCT-04 BOERNE, TX 78006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXCALIBUR LIGHT THERAPY SYSTEM, MODEL SGIEX-04-001 STARGATE INTERNATIONAL, INC. 510(k) NO: K041530(TRADITIONAL) ATTN: ROBERT H WALKER PHONE NO : 303-840-8206 10235 SOUTH PROGRESS WAY, #7 SE DECISION MADE: 14-OCT-04 PARKER, CO 80134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STAT K IN VITRO DIAGNOSTIC TEST SYSTEM STAT CHEM, INC. 510(k) NO: K042270(TRADITIONAL) ATTN: MARTIN J PATKO PHONE NO : 714-634-8456 619 NORTH POPLAR STREET SE DECISION MADE: 06-OCT-04 ORANGE, CA 92868 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERNGOLD 3.25 ERA DENTAL IMPLANT SYSTEM STERNGOLD 510(k) NO: K041271(ABBREVIATED) ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552 5 WHITCOMB AVE. SE DECISION MADE: 28-OCT-04 AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RETIC-CHEX FOR CELL-DYN STRECK LABORATORIES, INC. 510(k) NO: K042587(TRADITIONAL) ATTN: KERRIE OETTER PHONE NO : 402-537-5215 7002 SOUTH 109TH ST. SE DECISION MADE: 19-OCT-04 LA VISTA, NE 68128 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PAINPUMP1; PAINPUMP2 STRYKER CORP. 510(k) NO: K042405(TRADITIONAL) ATTN: JENNIFER MARS PHONE NO : 269-323-7700 4100 E. MILHAM AVE. SE DECISION MADE: 14-OCT-04 KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VACUUM ASSISTED CORE BIOPSY DEVICE SUROS SURGICAL SYSTEMS, INC. 510(k) NO: K042290(TRADITIONAL) ATTN: JOSEPH MARK PHONE NO : 317-344-7500 9502 ANGOLA COURT SUITE 3 SE DECISION MADE: 06-OCT-04 INDIANAPOLIS, IN 46268 510(k) STATEMENT DEVICE: POLYVAC INSTRUMENT DELIVERY SYSTEM SYMMETRY MEDICAL USA INC. 510(k) NO: K040223(TRADITIONAL) ATTN: DAVID FURR PHONE NO : 360-459-9475 7822 LADUE GLEN SE DECISION MADE: 22-OCT-04 FORT WAYNE, IN 46804 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AURORA DS SYNERON MEDICAL LTD. 510(k) NO: K041969(TRADITIONAL) ATTN: AMIR WALDMAN PHONE NO : 972 674 04616 POB 550 SE DECISION MADE: 19-OCT-04 YOKNEAM ELITE, ISRAEL 20692 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD SYNOVIS SURGICAL INNOVATIONS 510(k) NO: K041669(TRADITIONAL) ATTN: JAMES JENKINS PHONE NO : 651-796-7368 2575 UNIVERSITY AVE. WEST SE DECISION MADE: 27-OCT-04 ST. PAUL, MN 55114-1024 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BP-SPECT V1.O SYNTERMED, INC. 510(k) NO: K042258(TRADITIONAL) ATTN: KENNETH F VAN TRAIN PHONE NO : 714-281-1256 245 OWENS DR. SE DECISION MADE: 04-OCT-04 ANAHEIM, CA 92808 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM (LINE EXT SYNTHES (USA) 510(k) NO: K042135(TRADITIONAL) ATTN: LISA M BOYLE PHONE NO : 610-647-9700 P.O. BOX 1766 SE DECISION MADE: 07-OCT-04 1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA PAOLI, PA 19301-1222 DEVICE: SYNTHES (USA) LCP WRIST FUSION PLATES SYNTHES (USA) 510(k) NO: K042355(TRADITIONAL) ATTN: SHERI L MUSGNUNG PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 27-OCT-04 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES 1.0/1.2 MM PLUSDRIVE SCREWS SYNTHES (USA) 510(k) NO: K042356(TRADITIONAL) ATTN: LISA M BOYLE PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 07-OCT-04 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES LOW PROFILE RECONSTRUCTION PLATES SYNTHES (USA) 510(k) NO: K042377(TRADITIONAL) ATTN: LISA M BOYLE PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 07-OCT-04 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES CONTOURED SYNMESH SPACER SYNTHES SPINE 510(k) NO: K041389(SPECIAL) ATTN: ANGELA MIKROULIS PHONE NO : 484-356-9616 1230 WILSON DRIVE SE DECISION MADE: 01-OCT-04 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IBD-SCAN TECHLAB, INC. 510(k) NO: K042071(TRADITIONAL) ATTN: DAVID M LYERLY PHONE NO : 540-953-1664 2001 KRAFT DR. SE DECISION MADE: 20-OCT-04 BLACKSBURG, VA 24060-6358 510(k) STATEMENT DEVICE: SMK, CX, CXE, RCN TECHNOMED EUROPE 510(k) NO: K042375(TRADITIONAL) ATTN: RENE RONCKEN PHONE NO : 31 43 4086868 AMERIKALAAN 71 SE DECISION MADE: 26-OCT-04 MAASTRICHT AIRPORT, NETHERLANDS 61510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TECNO REUSABLE BIPOLAR CABLES, MODEL 190-100 AND 190-110 TECNO INSTRUMENTS (PVT.) LTD. 510(k) NO: K042608(TRADITIONAL) ATTN: MOHAN RATANCHANDANI PHONE NO : 516-482-9001 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 18-OCT-04 GREAT NECK,, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOUNDATION TERUMO CORP. 510(k) NO: K040783(TRADITIONAL) ATTN: KEITH A BARRITT, ESQ. PHONE NO : 202-783-5070 1425 K STREET N.W. SE DECISION MADE: 13-OCT-04 SUITE 1100 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20005 DEVICE: ADVENTURE A10 ULRICH ALBER GMBH 510(k) NO: K042535(TRADITIONAL) ATTN: RALF LEDDA PHONE NO : 074 321 0060 VOR DEM WEISSEN STEIN 21 SE DECISION MADE: 05-OCT-04 ALBSTADT-TAILFINGEN, GERMANY D-724510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ENDOREZ ULTRADENT PRODUCTS, INC. 510(k) NO: K042756(SPECIAL) ATTN: TAMMY LAVERY PHONE NO : 801-553-4200 505 WEST 10200 SOUTH SE DECISION MADE: 26-OCT-04 SOUTH JORDAN, UT 84095 510(k) STATEMENT DEVICE: UNFORS PATIENT SKIN DOSIMETER (PSD) UNFORS INC. 510(k) NO: K042698(TRADITIONAL) ATTN: PATRICK R PYERS PHONE NO : 860-355-2588 123 LITCHFIELD RD. SE DECISION MADE: 22-OCT-04 NEW MILFORD, CT 06776 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VALLY FORGE SCIENTIFIC MALIS BIPOLAR DISPOSABLE FINGER OPERATED VALLEY FORGE SCIENTIFIC CORP. 510(k) NO: K042604(SPECIAL) ATTN: JERRY L MALIS PHONE NO : 610-666-7500 136 GREEN TREE RD. SE DECISION MADE: 22-OCT-04 P.O. BOX 1179 510(k) SUMMARY AVAILABLE FROM FDA OAKS, PA 19456 DEVICE: ON-BOARD IMAGER DEVICE VARIAN MEDICAL SYSTEMS 510(k) NO: K042720(SPECIAL) ATTN: VY TRAN PHONE NO : 650-424-5731 3100 HANSEN WAY SE DECISION MADE: 29-OCT-04 M/S E-110 510(k) SUMMARY AVAILABLE FROM FDA PALO ALTO, CA 94304-1129 DEVICE: HDS INTRA-ORAL IMAGING SYSTEM VATECH VALUE ADDED TECHNOLOGY CO.,510(k) NO: K042372(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 P.O. BOX 7007 SE DECISION MADE: 04-OCT-04 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JEJE TEETHER VIBE 2000 510(k) NO: K034017(TRADITIONAL) ATTN: CAROL PATTERSON PHONE NO : 949-462-0900 21911 ERIE LANE SE DECISION MADE: 18-OCT-04 LAKE FOREST, CA 93030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISTAKON (SENOFILCON A) SOFT CONTACT LENS VISTAKON 510(k) NO: K042275(TRADITIONAL) ATTN: ANNETTE M HILLRING PHONE NO : 813-269-8246 3012 ST. CHARLES DR. SE DECISION MADE: 28-OCT-04 TAMPA, FL 33618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IONOFIL PLUS AC VOCO GMBH 510(k) NO: K042669(SPECIAL) ATTN: GERALD W SHIPPS PHONE NO : 541-389-5935 19379 BLUE LAKE LOOP SE DECISION MADE: 20-OCT-04 BEND, OR 97702 510(k) STATEMENT DEVICE: URO PRO W.O.M. WORLD OF MEDICINE AG 510(k) NO: K042457(TRADITIONAL) ATTN: SUSANNE RAAB PHONE NO : 781-749-4656 119 SOUTH ST. SE DECISION MADE: 25-OCT-04 HINGHAM, MA 02043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RM3 RENAL PRESERVATION SYSTEM WATERS INSTRUMENTS, INC. 510(k) NO: K042224(SPECIAL) ATTN: DAVE SCHOLLMAN PHONE NO : 763-509-7423 13705 26TH AVENUE N. SE DECISION MADE: 22-OCT-04 SUITE 102 510(k) SUMMARY AVAILABLE FROM FDA MINNEAPOLIS, MN 55441-3644 DEVICE: WIDE 1MP LCD MONITOR SYSTEM WIDE CORPORATION 510(k) NO: K042634(TRADITIONAL) ATTN: CARL ALLETTO PHONE NO : 940-300-8601 1100 LAKEVIEW BLVD. SE DECISION MADE: 08-OCT-04 DENTON, TX 76208 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: LOCON VLS DISTAL RADIUS PLATE SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K042358(SPECIAL) ATTN: JEANINE H REDDEN PHONE NO : 901-867-4522 5677 AIRLINE RD. SE DECISION MADE: 07-OCT-04 ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMLUCK, YA HORNG YA HORNG ELECTRONIC CO., LTD. 510(k) NO: K042581(TRADITIONAL) ATTN: JEN KE-MIN PHONE NO : 886 3 5208829 NO. 58, FU-CHIUN ST. SE DECISION MADE: 13-OCT-04 HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATHENA MULTI-LYTE ANA-II TEST SYSTEM ZEUS SCIENTIFIC, INC. 510(k) NO: K042416(SPECIAL) ATTN: MARK J KOPNITSKY PHONE NO : 908-526-3744 P.O. BOX 38 SE DECISION MADE: 08-OCT-04 RARITAN, NJ 08869 510(k) STATEMENT DEVICE: NCB PLATING SYSTEM ZIMMER GMBH 510(k) NO: K042695(TRADITIONAL) ATTN: STEPHEN H MCKELVEY PHONE NO : 574-372-4944 P.O. BOX 708 SE DECISION MADE: 29-OCT-04 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEXGEN POROUS, HA/TCP, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE C ZIMMER, INC. 510(k) NO: K041100(SPECIAL) ATTN: DALENE T BINKLEY PHONE NO : 574-372-4907 P.O. BOX 708 SE DECISION MADE: 29-OCT-04 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMOVAC BLOOD REINFUSION SYSTEM ZIMMER, INC. 510(k) NO: K041525(TRADITIONAL) ATTN: CINDY J DICKEY PHONE NO : 330-364-9493 PO BOX 10 200 W. OHIO AVENUE SE DECISION MADE: 14-OCT-04 DOVER, OH 44622-0010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX PROLONG HIGHLY CROSSLINKE ZIMMER, INC. 510(k) NO: K042271(SPECIAL) ATTN: BRANDON HIPSHER PHONE NO : 574-371-8083 P.O. BOX 708 SE DECISION MADE: 13-OCT-04 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES ZIMMER, INC. 510(k) NO: K042598(TRADITIONAL) ATTN: NOAH BARTSCH PHONE NO : 574-371-8552 P.O. BOX 708 SE DECISION MADE: 29-OCT-04 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL H ZOLL MEDICAL CORP. 510(k) NO: K042302(SPECIAL) ATTN: SEAN REYNOLDS PHONE NO : 978-421-9386 269 MILL ROAD SE DECISION MADE: 26-OCT-04 CHELMSFORD, MA 01824-4105 510(k) STATEMENT DEVICE: ZOLL M SERIES ETC02 LOFLO OPTION ZOLL MEDICAL CORP. 510(k) NO: K042417(SPECIAL) ATTN: SEAN REYNOLDS PHONE NO : 978-421-9386 269 MILL ROAD SE DECISION MADE: 05-OCT-04 CHELMSFORD, MA 01824-4105 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 277 TOTAL WITH SUMMARIES 240 TOTAL WITH STATEMENTS 37
Updated November 5, 2004
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