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Medical Devices
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October 2004 510(k) Clearances
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
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