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510(k)s Final Decisions Rendered for January 2003 |
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-JAN-2003 THROUGH 31-JAN-2003 DEVICE: PICCOLO TRIGLYCERIDES TEST SYSTEM ABAXIS, INC. 510(k) NO: K023639(TRADITIONAL) ATTN: DENNIS M BLEILE PHONE NO : 510-675-6515 3240 WHIPPLE RD. SE DECISION MADE: 24-JAN-03 UNION CITY, CA 94587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PICCOLO HDL TEST SYSTEM ABAXIS, INC. 510(k) NO: K023640(TRADITIONAL) ATTN: DENNIS M BLEILE PHONE NO : 510-675-6515 3240 WHIPPLE RD. SE DECISION MADE: 24-JAN-03 UNION CITY, CA 94587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PICCOLO TOTAL CHOLESTEROL TEST SYSTEM ABAXIS, INC. 510(k) NO: K023642(TRADITIONAL) ATTN: DENNIS M BLEILE PHONE NO : 510-675-6515 3240 WHIPPLE RD. SE DECISION MADE: 24-JAN-03 UNION CITY, CA 94587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RHEUMATOID FACTOR (RF) ABBOTT LABORATORIES 510(k) NO: K024067(TRADITIONAL) ATTN: LINDA MORRIS PHONE NO : 972-518-6711 1920 HURD DRIVE SE DECISION MADE: 15-JAN-03 IRVING, TX 75038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE OR WITHOUT ROTATO ABBOTT LABORATORIES 510(k) NO: K024126(SPECIAL) ATTN: NICOHL R WILDING PHONE NO : 847-935-6557 200 ABBOTT PARK ROAD SE DECISION MADE: 14-JAN-03 D-389, BLDG J-45 510(k) STATEMENT ABBOTT PARK, IL 60064-3500 DEVICE: CHEMO DISPENSING PIN, MODEL 12495 ABBOTT LABORATORIES 510(k) NO: K024239(SPECIAL) ATTN: NICOHL R WILDING PHONE NO : 847-935-6557 DEPT 0389 BLDG J-45 SE DECISION MADE: 13-JAN-03 200 ABBOTT PARK ROAD 510(k) STATEMENT ABBOTT PARK, IL 60064-6133 DEVICE: LIFESHIELD PRIMARY IV SET CONV. PIN. CLAVE; LF LC 5000 PLUMSET-D ABBOTT LABORATORIES 510(k) NO: K030002(SPECIAL) ATTN: NOCOHL R WILDING PHONE NO : 847-935-6557 D-389, BLDG. J-45 SE DECISION MADE: 27-JAN-03 200 ABBOTT PARK ROAD 510(k) STATEMENT ABBOTT PARK, IL 60064-6133 DEVICE: PENTRA 80 ABX DIAGNOSTICS 510(k) NO: K024002(SPECIAL) ATTN: TIM LAWTON PHONE NO : 33 467 147320 PARC EUROMEDECINE SE DECISION MADE: 03-JAN-03 RUE DU CADUCEE 510(k) SUMMARY AVAILABLE FROM FDA MONPELLIER, FRANCE 34184 DEVICE: MODIFICATION TO PENTRA 60 AND PENTRA 60C+ ABX DIAGNOSTICS 510(k) NO: K030144(SPECIAL) ATTN: TIM LAWTON PHONE NO : 33 467 147320 PARC EUROMEDECINE SE DECISION MADE: 31-JAN-03 RUE DU CADUCEE 510(k) SUMMARY AVAILABLE FROM FDA MONPELLIER, FRANCE 34184 DEVICE: SOFT TISSUE ANCHORING WASHERS ACCU-SPEED, INCORPORATED 510(k) NO: K030031(TRADITIONAL) ATTN: ROBERT W SECOVICH PHONE NO : 978-448-0997 P.O. BOX 1008, 65 GAY ROAD SE DECISION MADE: 28-JAN-03 GROTON, MA 01450 510(k) STATEMENT DEVICE: ACIST GENTOO CONTRAST INJECTION SYSTEM ACIST MEDICAL SYSTEMS 510(k) NO: K020892(ABBREVIATED) ATTN: CARL M BEAURLINE PHONE NO : 952-995-9319 7450 FLYING CLOUDS DR. SE DECISION MADE: 27-JAN-03 SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA EDEN PRAIRIE, MN 55344 DEVICE: USA SERIES DUR 8 ELITE, USA SERIES DUR 8, MODELS DUR 8E, DUR 8 ACMI CORPORATION 510(k) NO: K023358(TRADITIONAL) ATTN: TERRENCE SULLIVAN PHONE NO : 508-804-2739 136 TURNPIKE ROAD SE DECISION MADE: 03-JAN-03 SOUTHBOROUGH, MA 01772 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST ADVANCE DIAGNOSTICS 510(k) NO: K023712(TRADITIONAL) ATTN: JANIS FREESTONE PHONE NO : 408-745-7455 764 SAN ALESO AVE. SE DECISION MADE: 31-JAN-03 SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AHL GENERIC GLASS IONOMER LUTING CEMENT ADVANCED HEALTHCARE LTD. 510(k) NO: K023981(TRADITIONAL) ATTN: BILL ETTINGER PHONE NO : 813-831-6161 2907 BAY TO BAY BLVD SE DECISION MADE: 31-JAN-03 # 214 510(k) STATEMENT TAMPA, FL 33629 DEVICE: AMI REPROCESSED FEMORAL COMPRESSION DEVICE ADVEN MEDICAL 510(k) NO: K012692(TRADITIONAL) ATTN: MARK W ALDANA PHONE NO : 806-745-7718 1001 SLATON HWY. SE DECISION MADE: 24-JAN-03 LUBBOCK, TX 79404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMISIL SCAR GEL AESTHETIC AND RECONSTRUCTIVE TECHN510(k) NO: K023678(TRADITIONAL) ATTN: CATHERINE RIPLE PHONE NO : 805-239-1059 5871 LONE PINE PLACE SE DECISION MADE: 23-JAN-03 PASO ROBLES, CA 93446 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO TEMNO BIOPSY NEEDLES ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K024120(SPECIAL) ATTN: SHARON NICHOLS PHONE NO : 847-785-3311 1500 WAUKEGAN RD. BLDG. WM SE DECISION MADE: 15-JAN-03 MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLO ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K024292(SPECIAL) ATTN: ERICA SETHI PHONE NO : 847-785-3337 1500 WAUKEGAN RD. BLDG. WM SE DECISION MADE: 09-JAN-03 MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036 ALPHATEK CORP. 510(k) NO: K023613(TRADITIONAL) ATTN: PAUL M KUPSCO PHONE NO : 708-345-0500 2000 SOUTH 25TH AVE. SE DECISION MADE: 23-JAN-03 BROADVIEW, IL 60153 510(k) STATEMENT DEVICE: RDH-2000 ANODIA SYSTEMS 510(k) NO: K023213(TRADITIONAL) ATTN: THAD OVERMYER PHONE NO : 866-246-2548 514 SOUTH THIRD STREET SE DECISION MADE: 16-JAN-03 DANVILLE, KY 40422 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURESET 3.0 ML RESERVOIR, MODEL 24-103 APPLIED DIABETES RESEARCH, INCORPO510(k) NO: K024056(TRADITIONAL) ATTN: JAMES BARLEY PHONE NO : 949-433-3058 28481 LAFALDA SE DECISION MADE: 17-JAN-03 LAGUNA NIGUEL, CA 92677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SILVERLON ADHESIVE STRIP ARGENTUM INTERNATIONAL LLC. 510(k) NO: K023609(TRADITIONAL) ATTN: BART FLICK PHONE NO : 706-782-6700 PO BOX 429 SE DECISION MADE: 17-JAN-03 LAKEMONT, GA 30552 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SILVERLON CONTACT WOUND DRESSING ARGENTUM INTERNATIONAL LLC. 510(k) NO: K023612(TRADITIONAL) ATTN: BART FLICK PHONE NO : 706-782-6700 PO BOX 429 SE DECISION MADE: 24-JAN-03 LAKEMONT, GA 30552 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: "LFRE" INDIRECT LARYNGOSCOPE ASTRALITE CORP. 510(k) NO: K023004(TRADITIONAL) ATTN: DORIAN SWARTZ PHONE NO : 818-398-7055 7701 WOODLEY AVE. SE DECISION MADE: 28-JAN-03 VAN NUYS, CA 91406 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AURORA MR-GUIDED INTERVENTIONAL SYSTEM AURORA IMAGING TECHNOLOGY, INC. 510(k) NO: K023686(TRADITIONAL) ATTN: ALAN OSLAN PHONE NO : 978-975-7530 39 HIGH STREET SE DECISION MADE: 29-JAN-03 NORTH ANDOVER, MA 01845 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAXONE IV FLUID/BLOOD WARMER, MODEL 102 AUTOMATIC MEDICAL TECHNOLOGIES, IN510(k) NO: K023653(TRADITIONAL) ATTN: CINDY MARTIN PHONE NO : 714-543-1168 1711 NORTH BUSH STREET SE DECISION MADE: 17-JAN-03 SANTA ANA, CA 92706 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAPID THERMAL EXCHANGE SYSTEM AVACORE TECHNOLOGIES, INC. 510(k) NO: K023934(TRADITIONAL) ATTN: CRAIG COOMBS PHONE NO : 415-531-1932 251 HIGH STREET, SUITE B SE DECISION MADE: 23-JAN-03 PALO ALTO, CA 94301 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: AVANT GUARDIAN 101 AVANT MEDICAL CORPORATION 510(k) NO: K024018(TRADITIONAL) ATTN: JOHN B SLATE PHONE NO : 858-273-3674 3914 KENDALL STREET SE DECISION MADE: 17-JAN-03 SAN DIEGO, CA 92109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DRX3000 AXIOM USA. INC 510(k) NO: K022602(TRADITIONAL) ATTN: JIM GIBSON PHONE NO : 813-969-2414 3830 GUNN HWY SE DECISION MADE: 23-JAN-03 TAMPA, FL 33624 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRASOUND SCANNER, TYPE 2400 B-K MEDICAL A/S 510(k) NO: K024236(SPECIAL) ATTN: VILLY BRAENDER PHONE NO : 011 454 4528100 MILEPARKEN 34 SE DECISION MADE: 17-JAN-03 HERLEV, DENMARK DK-2730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARCO MEDIS 5MP2 AURA BARCO NV 510(k) NO: K023533(TRADITIONAL) ATTN: FRANK FERGUSON PHONE NO : 858-587-1147 P.O. BOX 12038 SE DECISION MADE: 17-JAN-03 LA JOLLA, CA 92039-2038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BAYER ADVIA CENTAUR HER-2/NEU ASSAY BAYER CORP. 510(k) NO: K024017(TRADITIONAL) ATTN: KENNETH T EDDS PHONE NO : 914-524-2446 511 BENEDICT AVE. SE DECISION MADE: 30-JAN-03 TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL BAYER CORP. 510(k) NO: K024234(TRADITIONAL) ATTN: GEORGE M TANCOS PHONE NO : 219-262-6928 1884 MILES AVE. SE DECISION MADE: 23-JAN-03 P.O. BOX 70 510(k) SUMMARY AVAILABLE FROM FDA ELKHART, IN 46514-0070 DEVICE: ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650 BAYER DIAGNOSTICS CORP. 510(k) NO: K023840(TRADITIONAL) ATTN: ANDRES HOLLE PHONE NO : 914-524-3494 511 BENEDICT AVE SE DECISION MADE: 07-JAN-03 TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3 BAYER HEALTHCARE, LLC 510(k) NO: K030102(ABBREVIATED) ATTN: KENNETH T EDDS PHONE NO : 914-524-2446 511 BENEDICT AVENUE SE DECISION MADE: 24-JAN-03 TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SETPOINT CHEMISTRY CALIBRATOR BAYER HEALTHCARE, LLC 510(k) NO: K030169(ABBREVIATED) ATTN: KENNETH T EDDS PHONE NO : 914-524-2446 511 BENEDICT AVENUE SE DECISION MADE: 31-JAN-03 TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100 BECKMAN COULTER, INC. 510(k) NO: K023764(TRADITIONAL) ATTN: LYNN WEIST PHONE NO : 952-368-1271 1000 LAKE HAZELTINE DR. SE DECISION MADE: 28-JAN-03 CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, M BECKMAN COULTER, INC. 510(k) NO: K030012(SPECIAL) ATTN: BRENT TABER PHONE NO : 952-368-1323 1000 LAKE HAZELTINE DRIVE SE DECISION MADE: 17-JAN-03 CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD INSULIN SYRINGE BECTON DICKINSON & CO. 510(k) NO: K024112(SPECIAL) ATTN: JOHN A SCHALAGO PHONE NO : 201-847-5663 1 BECTON DRIVE SE DECISION MADE: 09-JAN-03 FRANKLIN LAKES, NJ 07417-1880 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM BECTON, DICKINSON AND COMPANY 510(k) NO: K023568(TRADITIONAL) ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287 7 LOVETON CIR. SE DECISION MADE: 24-JAN-03 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CIPROFLOXACIN GN BECTON, DICKINSON AND COMPANY 510(k) NO: K023895(TRADITIONAL) ATTN: MICHELLE B BANDY PHONE NO : 410-316-4778 7 LOVETON CIR. SE DECISION MADE: 08-JAN-03 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - RIFAMPIN 0.25-32 UG/M BECTON, DICKINSON AND COMPANY 510(k) NO: K024152(TRADITIONAL) ATTN: KATHRYN BABKA POWERS PHONE NO : 410-316-4260 7 LOVETON CIR. SE DECISION MADE: 31-JAN-03 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CEM-OSTETIC, MODELS CEMO-020O, CEMO-05P, CEMO-10P, CEMO-20P, AND BERKELEY ADVANCED BIOMATERIALS, IN510(k) NO: K022622(TRADITIONAL) ATTN: FRANCOIS GENIN PHONE NO : 510-883-1644 1933 DAVIS ST. SUITE 307 SE DECISION MADE: 09-JAN-03 SAN LEANDRO, CA 94577 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BI-OSTETIC BERKELEY ADVANCED BIOMATERIALS, IN510(k) NO: K023703(TRADITIONAL) ATTN: FRANCOIS GENIN PHONE NO : 510-883-1644 1933 DAVIS ST. SUITE 307 SE DECISION MADE: 30-JAN-03 SAN LEANDRO, CA 94577 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BICON TRANSITIONAL IMPLANT (BTI) SYSTEM BICON, INC. 510(k) NO: K023705(TRADITIONAL) ATTN: VINCENT J MORGAN PHONE NO : 617-524-4443 501 ARBOWAY SE DECISION MADE: 29-JAN-03 BOSTON, MA 02130 510(k) STATEMENT DEVICE: LIQUICHEK ANA CONTROL, SPECKLED PATTERN, POSITIVE, CATALOG #108 BIO-RAD 510(k) NO: K024217(TRADITIONAL) ATTN: YVETTE LLOYD PHONE NO : 949-598-1200 9500 JERONIMO RD. SE DECISION MADE: 15-JAN-03 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114 BIO-RAD 510(k) NO: K024218(TRADITIONAL) ATTN: YVETTE LLOYD PHONE NO : 949-598-1200 9500 JERONIMO RD. SE DECISION MADE: 17-JAN-03 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115 BIO-RAD 510(k) NO: K024219(TRADITIONAL) ATTN: YVETTE LLOYD PHONE NO : 949-598-1200 9500 JERONIMO RD. SE DECISION MADE: 15-JAN-03 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130 BIO-RAD 510(k) NO: K024220(TRADITIONAL) ATTN: YVETTE LLOYD PHONE NO : 949-598-1465 9500 JERONIMO RD. SE DECISION MADE: 17-JAN-03 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUICHEK ANA CONTROL HOMOGENEOUS PATTERN CONTROL, POSOTIVE, CAT BIO-RAD 510(k) NO: K024221(TRADITIONAL) ATTN: YVETTE LLOYD PHONE NO : 949-598-1200 9500 JERONIMO RD. SE DECISION MADE: 15-JAN-03 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUICHEK ANA CONTROL CENTROMERE PATTERN, POSITIVE, CATALOG #112 BIO-RAD 510(k) NO: K024222(TRADITIONAL) ATTN: YVETTE LLOYD PHONE NO : 949-598-1200 9500 JERONIMO RD. SE DECISION MADE: 15-JAN-03 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116 BIO-RAD 510(k) NO: K024223(TRADITIONAL) ATTN: YVETTE LLOYD PHONE NO : 949-598-1200 9500 JERONIMO RD. SE DECISION MADE: 13-JAN-03 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUICHEK ANTI-SMOOTH MUSCLE CONTROL, POSITIVE, CATALOG #129 BIO-RAD 510(k) NO: K024224(TRADITIONAL) ATTN: YVETTE LLOYD PHONE NO : 949-598-1200 9500 JERONIMO RD. SE DECISION MADE: 15-JAN-03 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUICHEK ANTI-NDNA CONTROL, POSITIVE, CATALOG #119 BIO-RAD 510(k) NO: K024225(TRADITIONAL) ATTN: YVETTE LLOYD PHONE NO : 949-598-1200 9500 JERONIMO RD. SE DECISION MADE: 15-JAN-03 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUICHEK ANTI-SCL-70 CONTROL, POSITIVE, CATALOG #116 BIO-RAD 510(k) NO: K024226(TRADITIONAL) ATTN: YVETTE LLOYD PHONE NO : 949-598-1200 9500 JERONIMO RD. SE DECISION MADE: 10-JAN-03 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUICHEK ANTI-MITOCHONDRIAL CONTROL, POSITIVE, CATALOG #127 BIO-RAD 510(k) NO: K024227(TRADITIONAL) ATTN: YVETTE LLOYD PHONE NO : 949-598-1200 9500 JERONIMO RD. SE DECISION MADE: 15-JAN-03 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, POSITIVE, CATALOG #111 BIO-RAD 510(k) NO: K024229(TRADITIONAL) ATTN: YVETTE LLOYD PHONE NO : 949-598-1200 9500 JERONIMO RD. SE DECISION MADE: 15-JAN-03 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUICHEK ANA CONTROL SET, POSITIVE: HOMOGENEOUS, SPECKLED, CENT BIO-RAD 510(k) NO: K024230(TRADITIONAL) ATTN: YVETTE LLOYD PHONE NO : 949-598-1200 9500 JERONIMO RD. SE DECISION MADE: 15-JAN-03 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUICHEK ANTI-MITOTIC SPINDLE PATTERN CONTROL, POSITIVE, CATALO BIO-RAD 510(k) NO: K024231(TRADITIONAL) ATTN: YVETTE LLOYD PHONE NO : 949-598-1200 9500 JERONIMO RD. SE DECISION MADE: 13-JAN-03 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113 BIO-RAD 510(k) NO: K024232(TRADITIONAL) ATTN: YVETTE LLOYD PHONE NO : 949-598-1200 9500 JERONIMO RD. SE DECISION MADE: 17-JAN-03 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GOOD LUBRICATIONS BIOFILM, INC. 510(k) NO: K020586(TRADITIONAL) ATTN: ROBERT L DE ARMOND PHONE NO : 760-727-9030 3121 SCOTT ST. SE DECISION MADE: 24-JAN-03 VISTA, CA 92083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERALAS D 980 LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT, MODE BIOLITEC, INC. 510(k) NO: K024088(SPECIAL) ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794 555 THIRTEENTH ST., NW SE DECISION MADE: 02-JAN-03 WASHINGTON, DC 20004-5910 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM BIOMET ORTHOPEDICS, INC. 510(k) NO: K024086(SPECIAL) ATTN: KACY ARNOLD PHONE NO : 574-267-6639 56 EAST BELL DRIVE SE DECISION MADE: 09-JAN-03 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: DHS DISPOSABLE HOOD SYSTEM BIOMET, INC. 510(k) NO: K021992(TRADITIONAL) ATTN: KACY ARNOLD PHONE NO : 574-372-1644 P.O. BOX 587 SE DECISION MADE: 14-JAN-03 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAXIM ACCEL KNEE SYSTEM BIOMET, INC. 510(k) NO: K023546(TRADITIONAL) ATTN: TRACY J BICKEL PHONE NO : 574-267-6639 56 EAST BELL DR. SE DECISION MADE: 17-JAN-03 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEO-CABLE SLEEVE BIOMET, INC. 510(k) NO: K024022(SPECIAL) ATTN: KACY ARNOLD PHONE NO : 574-372-1644 56 EAST BELL DR. SE DECISION MADE: 23-JAN-03 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FREEDOM CONSTRAINED LINERS BIOMET, INC. 510(k) NO: K030047(SPECIAL) ATTN: MAX T HEBEL PHONE NO : 219-267-6639 56 EAST BELL DRIVE SE DECISION MADE: 23-JAN-03 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46582 DEVICE: CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM BIOSENSE WEBSTER, INC. 510(k) NO: K020863(SPECIAL) ATTN: WILLIAM WELCH PHONE NO : 800-729-9010 3333 DIAMOND CANYON RD. SE DECISION MADE: 09-JAN-03 DIAMOND BAR, CA 91765 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIAGE CARDIAC CALIBRATION VERIFICATION CONTROLS, TRIAGE CARDIO BIOSITE INCORPORATED 510(k) NO: K030088(TRADITIONAL) ATTN: JEFFREY R DAHLEN PHONE NO : 858-455-4808 11030 ROSELLE ST. SE DECISION MADE: 17-JAN-03 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIAGE CARDIAC CONTROLS; TRIAGE CARDIO PROFILER CONTROLS BIOSITE INCORPORATED 510(k) NO: K030089(TRADITIONAL) ATTN: JEFFREY R DAHLEN PHONE NO : 858-455-4808 11030 ROSELLE ST. SE DECISION MADE: 23-JAN-03 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 30 BIOTRONIK, INC. 510(k) NO: K022360(TRADITIONAL) ATTN: JON BRUMBAUGH PHONE NO : 888-345-0374 6024 JEAN RD. SE DECISION MADE: 27-JAN-03 LAKE OSWEGO, OR 97035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUAL-LUMEN CATHETER BISTECH, INC. 510(k) NO: K024165(ABBREVIATED) ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552 5 WHITCOMB AVENUE SE DECISION MADE: 10-JAN-03 AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BONART ART-L2 LIGHT CURING UNIT BONART CO. LTD. 510(k) NO: K023721(TRADITIONAL) ATTN: ERIC L ONG PHONE NO : 909-594-8066 398 S. LEMON CREEK DRIVE SE DECISION MADE: 10-JAN-03 STE. L 510(k) STATEMENT WALNUT, CA 91789 DEVICE: VAXCEL WITH PASV PORT BOSTON SCIENTIFIC CORP. 510(k) NO: K030083(SPECIAL) ATTN: JODI LYNN GREENIZEN PHONE NO : 518-742-4338 10 GLENS FALLS TECHNICAL PARK SE DECISION MADE: 28-JAN-03 GLENS FALLS, NY 12801-3864 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED BOSTON SCIENTIFIC SCIMED, INC. 510(k) NO: K024048(SPECIAL) ATTN: TODD KORNMANN PHONE NO : 800-553-5878 ONE SCIMED PLACE SE DECISION MADE: 06-JAN-03 MAPLE GROVE, MN 55311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARD CONFORMEXX BILIARY STENT AND DELIVERY SYSTEM C.R. BARD, INC. 510(k) NO: K021994(ABBREVIATED) ATTN: AYMEE BERRY PHONE NO : 480-303-2752 1625 WEST 3RD STREET SE DECISION MADE: 02-JAN-03 TEMPE, AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARD ER URETERAL STENT WITH SUTURE C.R. BARD, INC. 510(k) NO: K022447(TRADITIONAL) ATTN: DONNA J WILSON PHONE NO : 770-784-6135 8195 INDUSTRIAL BLVD. SE DECISION MADE: 23-JAN-03 COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CANDELA SMOOTHBEAM LASER SYSTEM CANDELA CORP. 510(k) NO: K022884(TRADITIONAL) ATTN: LORAINE NELSON PHONE NO : 508-358-7637 530 BOSTON POST RD. SE DECISION MADE: 22-JAN-03 WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CANDELA GENTLE YAG LASER SYSTEM, VARIABLE PULSE YAG CANDELA CORP. 510(k) NO: K022951(TRADITIONAL) ATTN: LORRAINE NELSON PHONE NO : 508-358-7637 530 BOSTON POST RD. SE DECISION MADE: 27-JAN-03 WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VER CANOPUS MEDICAL SUPPLY CO., LTD. 510(k) NO: K023728(TRADITIONAL) ATTN: RUBY LIN PHONE NO : 011 886 227162107 201 FU-HSING NORTH RD., 10TH SE DECISION MADE: 07-JAN-03 FL. 510(k) STATEMENT TAIPEI, CHINA (TAIWAN) 105 DEVICE: KLOCK WATCH STYLE DIGITAL BLOOD PRESSURE MONITOR CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K023356(TRADITIONAL) ATTN: ALEX GONOROVSKY PHONE NO : 972 894 84600 2 PEKERIS STREET SE DECISION MADE: 16-JAN-03 REHOVOT, ISRAEL 510(k) STATEMENT DEVICE: CG-500 PMP PERSONAL MEDICAL PHONE SYSTEM CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K023689(TRADITIONAL) ATTN: ALEX GONOROVSKY PHONE NO : 972 8 9484600 2 PEKERIS ST. SE DECISION MADE: 17-JAN-03 PO BOX 527 510(k) STATEMENT REHOVOT, ISRAEL 76100 DEVICE: TM2005 PERSONAL MEDICAL PHONE CENTER CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K024365(SPECIAL) ATTN: ALEX GONOROVSKY PHONE NO : 972 894 84600 2 PERERIS ST., SCIENCE PARK SE DECISION MADE: 15-JAN-03 REHOVOT, ISRAEL 76100 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PEDIATRIC ATTENUATED DEFIBRILLATION ELECTRODES, MODEL 9730, POWE CARDIAC SCIENCE, INC. 510(k) NO: K022929(TRADITIONAL) ATTN: JOHN CARLINE PHONE NO : 952-939-4181 16931 MILLIKAN AVE. SE DECISION MADE: 27-JAN-03 IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIMA ABLATION SYSTEM CARDIMA, INC. 510(k) NO: K022008(TRADITIONAL) ATTN: ROBERT A CHIN PHONE NO : 650-593-5225 25 HARTFORD AVENUE SE DECISION MADE: 29-JAN-03 SAN CARLOS, CA 94070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000 CARDIOMEDICS, INC. 510(k) NO: K023427(TRADITIONAL) ATTN: GARY CLARK PHONE NO : 949-863-2500 18872 BARDEEN AVE. SE DECISION MADE: 07-JAN-03 IRVINE, CA 92612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100 CARDIOVENTION, INC. 510(k) NO: K021694(TRADITIONAL) ATTN: TESSA YAMUT PHONE NO : 408-844-5130 3045 STENDER WAY SE DECISION MADE: 08-JAN-03 SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE CENTERPLUS ORTHOPEDICS, INC 510(k) NO: K023528(TRADITIONAL) ATTN: MITCHELL A DHORITY PHONE NO : 512-432-9202 9900 SPECTRUM DRIVE SE DECISION MADE: 17-JAN-03 AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CDS 3-PD HEMATOLOGY CONTROLS CLINICAL DIAGNOSTIC SOLUTIONS, INC510(k) NO: K024173(TRADITIONAL) ATTN: ANDREW C SWANSON PHONE NO : 954-791-7118 1660 N.W. 65TH AVE., SUITE 2 SE DECISION MADE: 14-JAN-03 PLANTATION, FL 33313 510(k) STATEMENT DEVICE: COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS AN CLINICAL INNOVATIONS, INC. 510(k) NO: K022023(TRADITIONAL) ATTN: WILLIAM DEAN WALLACE PHONE NO : 801-268-8200 747 WEST 4170 SOUTH SE DECISION MADE: 07-JAN-03 MURRAY, UT 84123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LINICAL IMMUNOLOGY CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN CLINIQA CORPORATION 510(k) NO: K030074(TRADITIONAL) ATTN: CAROL RUGGIERO PHONE NO : 760-744-1900 1432 SOUTH MISSION ROAD SE DECISION MADE: 21-JAN-03 FALLBROOK, CA 92028 510(k) STATEMENT DEVICE: LINICAL PROTEIN 5 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN C CLINIQA CORPORATION 510(k) NO: K030150(TRADITIONAL) ATTN: CAROL RUGGIERO PHONE NO : 760-744-1900 1432-B SOUTH MISSION RD. SE DECISION MADE: 28-JAN-03 FALLBROOK, CA 92028 510(k) STATEMENT DEVICE: BIO-CYBERNETIC CARDIO-DIAGNOSIS SYSTEM (BKD) CLOVER HI-TECH INC. 510(k) NO: K022596(TRADITIONAL) ATTN: CECILIA L YU PHONE NO : 626-964-6680 17800 CASTLETON STREET SE DECISION MADE: 31-JAN-03 SUITE 415 510(k) STATEMENT CITY OF INDUSTRY, CA 91748 DEVICE: COALESCENT SURGICAL U-CLIP AND ACCESSORIES COALESCENT SURGICAL 510(k) NO: K024366(SPECIAL) ATTN: MICHAEL A DANIEL PHONE NO : 415-407-0223 559 EAST WEDDELL DR. SE DECISION MADE: 17-JAN-03 SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPEEDICATH COLOPLAST CORP. 510(k) NO: K023254(TRADITIONAL) ATTN: ELIZABETH BOOTS PHONE NO : 507-386-4362 1940 COMMERCE DR. SE DECISION MADE: 27-JAN-03 NORTH MANKATO, MN 56003 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPUMEDICS SOMTE SYSTEM COMPUMEDICS LIMITED 510(k) NO: K021176(TRADITIONAL) ATTN: CONSTANCE G BUNDY PHONE NO : 763-574-1976 6740 RIVERVIEW TERRACE SE DECISION MADE: 21-JAN-03 MINNEAPOLIS,, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER COMPUTER MOTION, INC. 510(k) NO: K024294(SPECIAL) ATTN: CATHY STUPAK PHONE NO : 805-685-3729 130-B CREMONA DRIVE SE DECISION MADE: 08-JAN-03 SANTA BARBARA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHARP VIEW IMAGE ENHANCEMENT SYSTEM CONTEXT VISION AB 510(k) NO: K024028(TRADITIONAL) ATTN: KENT STRANDLUND PHONE NO : 460 133 58561 STORGATAN 24 SE DECISION MADE: 24-JAN-03 LINKOPING, SWEDEN SE-582 23 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYDNEY IVF EMBRYO BIOPSY MEDIUM COOK OB/GYN 510(k) NO: K023850(TRADITIONAL) ATTN: DEBBIE SCHMITT PHONE NO : 812-829-6500 1100 W. MORGAN STREET SE DECISION MADE: 22-JAN-03 SPENCER, IN 47460 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COOPERSURGICAL OOCYTE RECOVERY NEEDLES COOPERSURGICAL, INC. 510(k) NO: K023930(TRADITIONAL) ATTN: JOSEPH M AZARY PHONE NO : 203-944-9320 P.O. BOX 2156 SE DECISION MADE: 22-JAN-03 HUNTINGTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATI CORGENIX, INC. 510(k) NO: K024195(SPECIAL) ATTN: NANCI DEXTER PHONE NO : 303-457-4345 12061 TEJON ST. SE DECISION MADE: 03-JAN-03 WESTMINSTER, CO 80234 510(k) STATEMENT DEVICE: REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KI CORGENIX, INC. 510(k) NO: K024196(SPECIAL) ATTN: NANCI DEXTER PHONE NO : 303-457-4345 12061 TEJON ST. SE DECISION MADE: 03-JAN-03 WESTMINSTER, CO 80234 510(k) STATEMENT DEVICE: COSMED MICROQUARK COSMED S.R.L. 510(k) NO: K020745(TRADITIONAL) ATTN: ROBERT SCHIFF PHONE NO : 973-227-1830 1129 BLOOMFIELD AVENUE SE DECISION MADE: 02-JAN-03 WEST CALDWELL, NJ 07006 510(k) STATEMENT DEVICE: VISORB SWIFT CP MEDICAL 510(k) NO: K023710(TRADITIONAL) ATTN: MARY ANN GREENAWALT PHONE NO : 503-232-1555 836 N.E. 24TH AVE. SE DECISION MADE: 17-JAN-03 PORTLAND, OR 97232 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MELADINE NATURAL MELANIN ENHANCER, PRODUCT NUMBER CT81602AA CREATIVE TECHNOLOGIES, INC. 510(k) NO: K022807(TRADITIONAL) ATTN: ELIZABETH P NOBLE PHONE NO : 704-640-5547 423 BETHEL DRIVE SE DECISION MADE: 29-JAN-03 SALISBURY, NC 28144 510(k) STATEMENT DEVICE: STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDM DADE BEHRING, INC. 510(k) NO: K022976(TRADITIONAL) ATTN: RICHARD M VAUGHT PHONE NO : 302-631-6567 GLASGOW BUSINESS COMMUNITY SE DECISION MADE: 16-JAN-03 BLDG 500, MS 514 P.O.BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: MODIFICATION TO STANDARD HUMAN PLASMA DADE BEHRING, INC. 510(k) NO: K023141(TRADITIONAL) ATTN: DONNA A WOLF PHONE NO : 302-631-0384 514 GBC DRIVE SE DECISION MADE: 16-JAN-03 NEWARK, DE 19702 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DATEX-OHMEDA S/5 ENTROPY MODULE, M-ENTROPY AND ACCESSORIES DATEX-OHMEDA 510(k) NO: K023459(TRADITIONAL) ATTN: JOEL KENT PHONE NO : 781 449 8685 86 PILGRIM ROAD SE DECISION MADE: 13-JAN-03 NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETERS DELTEC, INC. 510(k) NO: K022221(TRADITIONAL) ATTN: LISA STONE PHONE NO : 651-628-7224 1265 GREY FOX RD. SE DECISION MADE: 30-JAN-03 ST. PAUL, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XENO III DENTAL ADHESIVE DENTSPLY INTL. 510(k) NO: K023776(TRADITIONAL) ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511 570 WEST COLLEGE AVE SE DECISION MADE: 23-JAN-03 YORK, PA 17404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOSS MIAMI SPINAL SYSTEM PIN NUT DEPUY ACROMED 510(k) NO: K023804(SPECIAL) ATTN: LISA GILMAN PHONE NO : 508-880-8287 325 PARAMOUNT DR. SE DECISION MADE: 23-JAN-03 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEVEX MESH SYSTEM DEPUY ACROMED 510(k) NO: K023835(SPECIAL) ATTN: KAREN F JURCZAK PHONE NO : 508-828-3704 325 PARAMOUNT DR. SE DECISION MADE: 29-JAN-03 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MONARCH SPINE SYSTEM DEPUY ACROMED 510(k) NO: K024348(SPECIAL) ATTN: LISA GILMAN PHONE NO : 508-880-8287 325 PARAMOUNT DR. SE DECISION MADE: 28-JAN-03 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLUCOSE-SL-C ASSAY, MODEL 257-30 DIAGNOSTIC CHEMICALS LTD. 510(k) NO: K023739(TRADITIONAL) ATTN: NANCY OLSCAMP PHONE NO : 902 566 1396 16 MCCARVILLE ST SE DECISION MADE: 17-JAN-03 CHARLOTTETOWN, PE, CANADA C1E2A6 510(k) STATEMENT DEVICE: ACCULEAF DIREX SYSTEMS CORP. 510(k) NO: K021338(TRADITIONAL) ATTN: LARISA GERSHTEIN PHONE NO : 888-874-7837 11 MERCER ROAD SE DECISION MADE: 07-JAN-03 NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIPTER X-1 COMPACT DUET DIREX SYSTEMS CORP. 510(k) NO: K023535(SPECIAL) ATTN: LARISA GERSHTEIN PHONE NO : 508-651-0900 11 MERCER ROAD SE DECISION MADE: 17-JAN-03 NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLASH-LITE II LED DENTAL CURING LIGHT DISCUS DENTAL, INC. 510(k) NO: K023748(TRADITIONAL) ATTN: GARY L HOLLAR PHONE NO : 310-845-8345 8550 HIGUERA STREET SE DECISION MADE: 17-JAN-03 CULVER CITY, CA 90232 510(k) STATEMENT DEVICE: VITIQUE SYSTEM DMG USA, INC. 510(k) NO: K023649(ABBREVIATED) ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552 5 WHITCOMB AVENUE SE DECISION MADE: 17-JAN-03 AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072 DRAGER MEDIZINTECHNIK GMBH 510(k) NO: K023289(SPECIAL) ATTN: JAMES J BRENNAN PHONE NO : 215-721-5400 3136 QUARRY ROAD SE DECISION MADE: 15-JAN-03 TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO EBI XFIX DFS SYSTEM EBI, L.P. 510(k) NO: K024129(SPECIAL) ATTN: JON CAPAROTTA PHONE NO : 973-299-9300 100 INTERPACE PKWY. SE DECISION MADE: 15-JAN-03 PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO EBI XFIX DFS SYSTEM METAPHYSEAL CORRECTION SYSTE EBI, L.P. 510(k) NO: K024248(SPECIAL) ATTN: FREDERIC TESTA PHONE NO : 973-299-9300 100 INTERPACE PKWY. SE DECISION MADE: 22-JAN-03 PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MUCOGRAFT ED. GEISTLICH SOEHNE AG FUER CHEMI510(k) NO: K012423(TRADITIONAL) ATTN: PETER S REICHERTZ PHONE NO : 202-857-6378 1050 CONNECTICUT AVE. NW SE DECISION MADE: 24-JAN-03 WASHINGTON, DC 20036 510(k) STATEMENT DEVICE: UNISIGHT SYSTEM WITH UNIGATE ELECTRONIC BUSINESS MACHINE CO., L510(k) NO: K023394(ABBREVIATED) ATTN: DAVID LIN PHONE NO : 808-945-3100 1600 KAPIDLANI BLVD SE DECISION MADE: 07-JAN-03 SUITE 1224 510(k) STATEMENT HONOLULU, HI 96814 DEVICE: MODIFICATION TO ANIMEC, MODELS AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5 ELLTEC CO., LTD. 510(k) NO: K024373(SPECIAL) ATTN: RIEKO SO PHONE NO : 81 52 2017308 SHIRAKAWA NO. 6 BLDG. 2-18-5 SE DECISION MADE: 28-JAN-03 NISHIKI, NAKA-KU 510(k) STATEMENT NAGOYA, JAPAN DEVICE: EPW POWERED WHEELCHAIR, GP-201 EMG TECHNOLOGY CO., LTD. 510(k) NO: K023148(TRADITIONAL) ATTN: KE-MIN JEN PHONE NO : 886 3 5208829 NO. 58, FU-CHINU ST. SE DECISION MADE: 24-JAN-03 HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ERBE VIO APC WITH ACCESSORIES ERBE USA, INC. 510(k) NO: K024047(SPECIAL) ATTN: JULIE STEPHENS PHONE NO : 770-923-7219 550 BELGRAVE LANE SE DECISION MADE: 08-JAN-03 TUCKER, GA 30084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NITREX NITINOL GUIDEWIRE EV3 CORPORATION 510(k) NO: K024021(SPECIAL) ATTN: PHIL NEURURER PHONE NO : 763-398-7094 4600 NATHAN LANE SE DECISION MADE: 24-JAN-03 PLYMOUTH, MN 55442-2920 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXEL SECURETOUCH PTP SYRINGE EXELINT INTL. CO. 510(k) NO: K011754(TRADITIONAL) ATTN: ARMAND HAMID PHONE NO : 310-649-0707 P.O. BOX 3194 SE DECISION MADE: 22-JAN-03 CULVER CITY, CA 90231-3194 510(k) STATEMENT DEVICE: AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE EXTERNAL COUNTERPULSATION LAB 510(k) NO: K021340(TRADITIONAL) ATTN: DAWEI CAI PHONE NO : 216-324-0100 85 WU JIN ROAD SE DECISION MADE: 30-JAN-03 SHANGHAI, CHINA 200080 510(k) STATEMENT DEVICE: LESSER METATARSAL PHALANGEAL JOINT IMPLANT FUTURA BIOMEDICAL 510(k) NO: K023531(TRADITIONAL) ATTN: LOUISE M FOCHT PHONE NO : 760-599-1670 990 PARK CENTER DR., SUITE H SE DECISION MADE: 17-JAN-03 VISTA, CA 92083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TEMPORARY CEMENT-DC010002 GC AMERICA, INC. 510(k) NO: K023727(TRADITIONAL) ATTN: TERRY L JORITZ PHONE NO : 708-597-0900 3737 WEST 127TH ST. SE DECISION MADE: 16-JAN-03 ALSIP, IL 60803 510(k) STATEMENT DEVICE: EXAJET GC AMERICA, INC. 510(k) NO: K023751(TRADITIONAL) ATTN: TERRY L JORITZ PHONE NO : 708-926-3105 3737 WEST 127TH ST. SE DECISION MADE: 22-JAN-03 ALSIP, IL 60803 510(k) STATEMENT DEVICE: GRADIA DIRECT GC AMERICA, INC. 510(k) NO: K023814(TRADITIONAL) ATTN: TERRY L JORITZ PHONE NO : 708-926-3105 3737 WEST 127TH ST. SE DECISION MADE: 30-JAN-03 ALSIP, IL 60803 510(k) STATEMENT DEVICE: JUPITER PROCESSING AND REVIEW WORKSTATION GE MEDICAL SYSTEMS, INC. 510(k) NO: K024137(SPECIAL) ATTN: LARRY A KROGER PHONE NO : 262-544-3894 3000 N. GRANDVIEW BLVD. SE DECISION MADE: 15-JAN-03 WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INNOVA 2000 AND INNOVA 2000S (MOBILE VERSION) GE MEDICAL SYSTEMS, INC. 510(k) NO: K024200(SPECIAL) ATTN: LARRY A KROGER PHONE NO : 262-544-3894 P.O. BOX 414 SE DECISION MADE: 16-JAN-03 MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NON-DEHP, POWDER FREE VINYL EXAMINATION GLOVES GENERAL GLOVES CORP. 510(k) NO: K024174(TRADITIONAL) ATTN: JOHN CHEN PHONE NO : 886 6 6803675 25 PEI MA, 16 LIN TUNG CHUNG SE DECISION MADE: 28-JAN-03 VILLAGE, TUNG SHAN HSIANG 510(k) STATEMENT TAINAN HSIEN, CHINA (TAIWAN) 733 DEVICE: GENZYME CONTRAST II HCG URINE/SERUM TEST GENZYME CORP. 510(k) NO: K023544(TRADITIONAL) ATTN: E.V. GOORCHENKO PHONE NO : 858-777-2614 ONE KENDALL SQUARE SE DECISION MADE: 16-JAN-03 CAMBRIDGE, MA 02139 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VACUETTE TRACE ELEMENTS TUBES GREINER BIO-ONE VACUETTE NORTH AME510(k) NO: K023971(TRADITIONAL) ATTN: JUDI SMITH PHONE NO : 410-592-2060 PO BOX 103 SE DECISION MADE: 27-JAN-03 BALDWIN, MD 21013 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE GUIDANT CORP. 510(k) NO: K030019(SPECIAL) ATTN: KRISTINE M TEICH PHONE NO : 651-582-5011 4100 HAMLINE AVE., NORTH SE DECISION MADE: 24-JAN-03 ST. PAUL, MN 55112-5798 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101 GVI TECHNOLOGY PARTNERS 510(k) NO: K023373(TRADITIONAL) ATTN: KEVIN M NURROCK PHONE NO : 330-963-4083 1470 ENTERPRISE PARKWAY SE DECISION MADE: 03-JAN-03 TWINSBURG, OH 44087 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HL888 HEALTH & LIFE CO., LTD. 510(k) NO: K023834(TRADITIONAL) ATTN: SUSAN CHEN PHONE NO : 886 2 32349600 6F,NO.407, CHUNG SHAN RD. SE DECISION MADE: 14-JAN-03 SEC.02, CHUNG HO CITY 510(k) STATEMENT TAIPEI HSIEN, CHINA (TAIWAN) 235 THIRD PARTY REVIEW DEVICE: ALUMINA V40 FEMORAL HEADS HOWMEDICA OSTEONICS CORP. 510(k) NO: K023901(TRADITIONAL) ATTN: DEBRA BING PHONE NO : 201-831-5413 59 ROUTE 17 SE DECISION MADE: 28-JAN-03 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYDROFERA BACTERIOSTATIC WOUND DRESSING HYDROFERA, LLC. 510(k) NO: K023138(TRADITIONAL) ATTN: HEATHER S BOND PHONE NO : 860-456-0677 322 MAIN ST., SUITE 1101 SE DECISION MADE: 17-JAN-03 WILLIMANTIC, CT 06226 510(k) STATEMENT DEVICE: CONCERT CRANIOPLAST IMMEDICA, INC. 510(k) NO: K023575(TRADITIONAL) ATTN: RUSSELL PAGANO PHONE NO : 202-546-1262 719 A STREET, NE SE DECISION MADE: 22-JAN-03 WASHINGTON, DC 20002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEXGEN COMPLETE KNEE SOLUTION - TRABECULAR METAL AUGMENTS IMPLEX CORP. 510(k) NO: K024161(SPECIAL) ATTN: MARCI HALEVI PHONE NO : 201-818-1800 80 COMMERCE DR. SE DECISION MADE: 15-JAN-03 ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CASSETTE/URINE HCG IND DIAGNOSTIC INC. 510(k) NO: K023638(TRADITIONAL) ATTN: DAVID LEE PHONE NO : 604 522 1619 1629 FOSTERS WAY SE DECISION MADE: 03-JAN-03 DELTA, B.C., CANADA V3M 6S7 510(k) STATEMENT DEVICE: IVUS PLUS INDEC SYSTEMS, INC. 510(k) NO: K024103(TRADITIONAL) ATTN: CAROL HUBLER PHONE NO : 650-903-9755 505 E. EVELYN SE DECISION MADE: 24-JAN-03 SUITE D 510(k) SUMMARY AVAILABLE FROM FDA MOUNTAIN VIEW, CA 94041 DEVICE: CELSIUS CONTROL SYSTEM INNERCOOL THERAPIES 510(k) NO: K022366(TRADITIONAL) ATTN: STEVE REITZLER PHONE NO : 858-713-9507 3931 SORRENTO VALLEY BLVD. SE DECISION MADE: 27-JAN-03 SAN DIEGO,, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERFORMA STEREO INSTRUMENTARIUM CORP. IMAGING DIVI510(k) NO: K023864(TRADITIONAL) ATTN: BRIAN BRONCATTI PHONE NO : 414-747-1030 300 WEST EDGERTON AVENUE SE DECISION MADE: 09-JAN-03 MILWAUKEE, WI 53207 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMOSIL FACTOR V DEFICIENT PLASMA INSTRUMENTATION LABORATORY CO. 510(k) NO: K023839(TRADITIONAL) ATTN: CAROL MARBLE PHONE NO : 781-861-4467 113 HARTWELL AVE. SE DECISION MADE: 14-JAN-03 LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMARTTROAE INTELLIGENT HEARING SYSTEMS 510(k) NO: K023859(TRADITIONAL) ATTN: EDWARD MISKIEL PHONE NO : 305-668-6102 7356 S.W. 48 ST. SE DECISION MADE: 08-JAN-03 MIAMI, FL 33155 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM INTERNATIONAL TECHNIDYNE CORP. 510(k) NO: K023561(TRADITIONAL) ATTN: JOHN CLAY PHONE NO : 800-272-1252 6 OLSEN AVE. SE DECISION MADE: 31-JAN-03 EDISON, NJ 08820 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTERPORE CROSS INTERNATIONAL ANTERIOR FIXATION DEVICE (AFD) INTERPORE CROSS INTL. 510(k) NO: K022143(TRADITIONAL) ATTN: LYNN M RODARTI PHONE NO : 949-453-3200 181 TECHNOLOGY DR. SE DECISION MADE: 23-JAN-03 IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SW-180 SHORTWAVE THERAPY UNIT ITO CO., LTD. 510(k) NO: K022846(TRADITIONAL) ATTN: T. WHIT ATHEY PHONE NO : 301-570-0013 2305 GOLD MINE ROAD SE DECISION MADE: 28-JAN-03 BROOKEVILLE, MD 20833 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LID CHAIN EYELID WEIGHTS JEDMED INSTRUMENT CO. 510(k) NO: K021750(TRADITIONAL) ATTN: CRAIG R PARKS PHONE NO : 314-845-3770 5416 JEDMED CT. SE DECISION MADE: 27-JAN-03 ST. LOUIS, MO 63129-2221 510(k) STATEMENT DEVICE: ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT JOHNSON & JOHNSON VISION CARE, INC510(k) NO: K024177(TRADITIONAL) ATTN: JAMES W PARZIALE PHONE NO : 904-443-1808 7500 CENTURION PKWY. SE DECISION MADE: 22-JAN-03 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA JACKSONVILLE, FL 32256 DEVICE: JOSTRA SINGLE STAGE VENOUS RETURN CATHETERS JOSTRA AG 510(k) NO: K020784(TRADITIONAL) ATTN: KATHLEEN JOHNSON PHONE NO : 610-932-7738 P.O. BOX 218 SE DECISION MADE: 09-JAN-03 OXFORD, PA 19363 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLOWLINE BIOPORE EPTFE VASCULAR GRAFT JOTEC GMBH 510(k) NO: K021547(TRADITIONAL) ATTN: JOE SHARBER PHONE NO : 406-586-7666 2430 N. 7TH AVE. STE 4 SE DECISION MADE: 24-JAN-03 BOZEMAN, MT 59715 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KSEA SCB ACC CONTROL KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K023704(TRADITIONAL) ATTN: JAMES A LEE PHONE NO : 310-410-2769 600 CORPORATE POINTE 5TH FLOOR SE DECISION MADE: 30-JAN-03 CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, K KING SYSTEMS CORP. 510(k) NO: K021634(TRADITIONAL) ATTN: TOM MCGRAIL PHONE NO : 800-642-5464 15011 HERRIMAN BLVD. SE DECISION MADE: 09-JAN-03 NOBLESVILLE, IN 46060 510(k) STATEMENT DEVICE: AURA 20 BIPOLAR ELECTROSURGICAL COAGULATOR, MODEL 26-2500 KIRWAN SURGICAL PRODUCTS, INC. 510(k) NO: K023482(TRADITIONAL) ATTN: KEVIN P PRARIO PHONE NO : 781-834-9500 180 ENTERPRISE DR. SE DECISION MADE: 15-JAN-03 MARSHFIELD, MA 02050 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE POLYMER COATED (ACRYLIC BASED) PATIENT EXAMINIATION KL-KEPONG RUBBER PRODUCTS SDN. BHD510(k) NO: K023866(TRADITIONAL) ATTN: YIM HOON PUNG PHONE NO : 605 357 1888 LADANG PINJI, BAHAGIAN SENGAT, SE DECISION MADE: 24-JAN-03 KAMPUNG KEPAYANG, 510(k) STATEMENT IPOH, PERAK, DARUL RIDZUAN, MALAYSIA 31300 DEVICE: REEVUE INDIRECT CALORIMETER, MODEL#8100 KORR MEDICAL TECHNOLOGIES, INC. 510(k) NO: K021490(TRADITIONAL) ATTN: SCOTT A KOFOED PHONE NO : 801-483-2080 3090 EAST 3300 SOUTH SE DECISION MADE: 02-JAN-03 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA SALT LAKE CITY, UT 84109 DEVICE: OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302 LEMAITRE VASCULAR, INC. 510(k) NO: K022145(TRADITIONAL) ATTN: JAMES ASHBY PHONE NO : 781-221-2266 26 RAY AVENUE SE DECISION MADE: 14-JAN-03 BURLINGTON, MA 01803 510(k) STATEMENT DEVICE: LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPER LEMAITRE VASCULAR, INC. 510(k) NO: K023688(TRADITIONAL) ATTN: JAMES ASHBY PHONE NO : 781-221-2266 26 RAY AVENUE SE DECISION MADE: 30-JAN-03 BURLINGTON, MA 01803 510(k) STATEMENT DEVICE: SKINTACT LEONHARD LANG CO. 510(k) NO: K024264(SPECIAL) ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035 P.O. BOX 560 SE DECISION MADE: 16-JAN-03 STILLWATER, MN 55082-0560 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SKINTACT LEONHARD LANG GMBH 510(k) NO: K023920(TRADITIONAL) ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035 P.O. BOX 560 SE DECISION MADE: 16-JAN-03 STILLWATER, MN 55082-0560 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL LEONHARD LANG GMBH 510(k) NO: K024247(SPECIAL) ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035 P.O. BOX 560 SE DECISION MADE: 16-JAN-03 STILLWATER, MN 55082-0560 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIDCOPLUS HEMODYNAMIC MONITOR SYSTEM, MODEL HM 70 LIDCO LTD. 510(k) NO: K023960(SPECIAL) ATTN: GREGORY SPELLER PHONE NO : 44 020 77491500 16 ORSMAN RD. SE DECISION MADE: 09-JAN-03 LONDON, UNITED KINGDOM N15QJ 510(k) STATEMENT DEVICE: LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002 LIMERICK, INC. 510(k) NO: K021739(TRADITIONAL) ATTN: PATRICIA KELLY PHONE NO : 818-566-3060 903 NORTH SAN FERNANDO BLVD. SE DECISION MADE: 10-JAN-03 SUITE 5 510(k) SUMMARY AVAILABLE FROM FDA BURBANK, CA 91504 DEVICE: PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), # LIN-ZHI INTERNATIONAL, INC. 510(k) NO: K023795(TRADITIONAL) ATTN: CHIU CHIN CHANG PHONE NO : 408-944-0360 2391 ZANKER RD., SUITE 340 SE DECISION MADE: 21-JAN-03 SAN JOSE, CA 95131-1124 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANGIONEW-IV LIVING DATA TECHNOLOGIES CORPORATI510(k) NO: K023701(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502 55 NORTHERN BLVD. SUITE 200 SE DECISION MADE: 30-JAN-03 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUMEND FRONTRUNNER CTO CATHETER LUMEND, INC. 510(k) NO: K023114(TRADITIONAL) ATTN: MICHAEL A DANIEL PHONE NO : 650-364-1400 400 CHESAPEAKE DR. SE DECISION MADE: 23-JAN-03 REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VALIDATE CHEM 10 CALIBRATION VERIFICATION TEST SET, MODEL 110 MAINE STANDARDS CO. 510(k) NO: K023410(TRADITIONAL) ATTN: CHRISTINE BEACH PHONE NO : 207-892-1300 765 ROOSEVELT TRAIL SE DECISION MADE: 06-JAN-03 SUITE 9A 510(k) SUMMARY AVAILABLE FROM FDA WINDHAM, ME 04062-5365 DEVICE: RTDOSEPLAN MATH RESOLUTIONS, LLC. 510(k) NO: K022961(TRADITIONAL) ATTN: WENDEL DEAN RENNER PHONE NO : 410-997-9578 5975 GALES LANE SE DECISION MADE: 31-JAN-03 COLUMBIA, MD 21045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 14 MEDI-GLOBE CORP. 510(k) NO: K010714(TRADITIONAL) ATTN: GERHARDT SEIWERTH PHONE NO : 498 032 973345 MEDI-GLOB-STRASSE 1-5 SE DECISION MADE: 21-JAN-03 ACHENMUHLE, GERMANY 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDS-4 NEUROMUSCULAR STIMULATOR MEDICAL EQUIPMENT DEVICE SPECIALIS510(k) NO: K023435(TRADITIONAL) ATTN: C. A. TEKLINSKI PHONE NO : 619-665-4912 32158 CAMINO CAPISTRANO SE DECISION MADE: 13-JAN-03 SUITE A-416 510(k) STATEMENT SAN JUAN CAPISTRANO, CA 92675 DEVICE: MEDS-4 NEUROMUSCULAR STIMULATOR MEDICAL EQUIPMENT DEVICE SPECIALIS510(k) NO: K023439(TRADITIONAL) ATTN: DARREL BLOMBERG PHONE NO : 909-393-9427 32158 CAMINO CAPISTRANO SE DECISION MADE: 13-JAN-03 SUITE A-416 510(k) STATEMENT SAN JUAN CAPISTRANO, CA 92675 DEVICE: MEDS-3 NEUROMUSCULAR STIMULATOR MEDICAL EQUIPMENT DEVICE SPECIALIS510(k) NO: K023443(TRADITIONAL) ATTN: DARREL BLOMBERG PHONE NO : 909-393-9427 32158 CAMINO CAPISTRANO SE DECISION MADE: 13-JAN-03 SUITE A-416 510(k) STATEMENT SAN JUAN CAPISTRANO, CA 92675 DEVICE: MEDS-3 NEUROMUSCULAR STIMULATOR MEDICAL EQUIPMENT DEVICE SPECIALIS510(k) NO: K023446(TRADITIONAL) ATTN: DARREL BLOMBERG PHONE NO : 909-393-9427 32158 CAMINO CAPISTRANO SE DECISION MADE: 13-JAN-03 SUITE A-416 510(k) STATEMENT SAN JUAN CAPISTRANO, CA 92675 DEVICE: PACSPLUS MEDICAL STANDARD CO., LTD. 510(k) NO: K023460(TRADITIONAL) ATTN: CARL ALLETTO PHONE NO : 214-262-4209 1100 LAKEVIEW BLVD. SE DECISION MADE: 09-JAN-03 DENTON, TX 76201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUANTITATIVE VASCULAR ANGIOGRAPHY - CMS MEDIS MEDICAL IMAGING SYSTEMS, B.V510(k) NO: K023970(TRADITIONAL) ATTN: J I HOLLANDER PHONE NO : 31 71 5223244 POORTGEBOUW RIJNSBURGERWEG 10 SE DECISION MADE: 24-JAN-03 LEIDEN, NETHERLANDS 2333 AA 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUISHIELD-S (0.7G), MODEL LS 0010, LIQUISHIELD-S (2.0G), MODEL MEDLOGIC GLOBAL LIMITED 510(k) NO: K023163(TRADITIONAL) ATTN: HOWARD BEAUMONT PHONE NO : 441 752 209955 WESTERN WOOD WAY SE DECISION MADE: 13-JAN-03 LANGAGE SCIENCE PARK 510(k) SUMMARY AVAILABLE FROM FDA PLYMOUTH, DEVON, UNITED KINGDOM PL7 5BG DEVICE: MEDRAD STELLANT CT INJECTOR SYSTEM MEDRAD, INC. 510(k) NO: K023183(SPECIAL) ATTN: FRANK W PELC III PHONE NO : 412-767-2400 ONE MEDRAD DR. SE DECISION MADE: 10-JAN-03 INDIANOLA, PA 15051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MALLEABLE SINGLE STAGE VENOUS CANNULA, MODELS 68112-68140 (15 TO MEDTRONIC CARDIAC SURGICAL PRODUCT510(k) NO: K022272(TRADITIONAL) ATTN: ROGER BRINK PHONE NO : 616-643-7337 620 WATSON STREET SW SE DECISION MADE: 08-JAN-03 GRAND RAPIDS, MI 49504-6393 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CATHETER INTRODUCER FOR THE STEALTHSTATION SYSTEM MEDTRONIC SURGICAL NAVIGATION TECH510(k) NO: K022126(TRADITIONAL) ATTN: VICTORIA G RENDON PHONE NO : 720-890-3200 826 COAL CREEK CIR. SE DECISION MADE: 03-JAN-03 LOUISVILLE, CO 80027 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIM-PRS MEDTRONIC XOMED, INC. 510(k) NO: K024316(TRADITIONAL) ATTN: MARTIN SARGENT PHONE NO : 904-934-7487 6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 06-JAN-03 JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM MEDTRONIC, INC. 510(k) NO: K023878(SPECIAL) ATTN: FRED L BOUCHER PHONE NO : 978-777-0042 37A CHERRY HILL DRIVE SE DECISION MADE: 24-JAN-03 DANVERS, MA 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONE PIECE PEDIATRIC ARTERIAL CANNULA, MODEL: 77006, 77106 MEDTRONIC, INC. 510(k) NO: K024069(SPECIAL) ATTN: RONALD W BENNETT PHONE NO : 763-391-9086 7611 NORTHLAND DRIVE SE DECISION MADE: 08-JAN-03 MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMUNOCARD STAT! E. COLI O157 PLUS MERIDIAN BIOSCIENCE, INC. 510(k) NO: K023599(TRADITIONAL) ATTN: SUSAN ROLIH PHONE NO : 513-271-3700 3471 RIVER HILLS DR. SE DECISION MADE: 03-JAN-03 CINCINNATI, OH 45244 510(k) STATEMENT DEVICE: MICROVISION SCLERAL BUCKLING COMPONENTS MICROVISION, INC. 510(k) NO: K023481(TRADITIONAL) ATTN: SHEILA HEMEON-HEYER, JD, RAPHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 08-JAN-03 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MILLEX VV, GV, AND HV SYRINGE FILTER UNITS MILLIPORE CORP. 510(k) NO: K023892(TRADITIONAL) ATTN: THOMAS BORROWS PHONE NO : 781-533-2622 80 ASHBY ROAD SE DECISION MADE: 17-JAN-03 BEDFORD, MA 01730 510(k) STATEMENT DEVICE: BODY BOX 5500 MORGAN SCIENTIFIC, INC. 510(k) NO: K022636(TRADITIONAL) ATTN: PATRICK F MORGAN PHONE NO : 978-521-4440 151 ESSEX ST. SE DECISION MADE: 13-JAN-03 HAVERHILL, MA 01832 510(k) STATEMENT DEVICE: OBC-250-PAN BREAST ARRAY COIL MRI DEVICES CORP. 510(k) NO: K024208(SPECIAL) ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402 1515 PARAMOUNT DR. SE DECISION MADE: 07-JAN-03 WAUKESHA, WI 53186 510(k) STATEMENT DEVICE: QWH-250-PAN WRIST ARRAY COIL MRI DEVICES CORP. 510(k) NO: K024209(SPECIAL) ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402 1515 PARAMOUNT DR. SE DECISION MADE: 09-JAN-03 WAUKESHA, WI 53186 510(k) STATEMENT DEVICE: HRH-127-8 HEAD ARRAY COIL FOR GE SIGNA 3T EXCITE MRI SYSTEM MRI DEVICES CORP. 510(k) NO: K024352(SPECIAL) ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402 1515 PARAMOUNT DR. SE DECISION MADE: 09-JAN-03 WAUKESHA, WI 53186 510(k) STATEMENT DEVICE: PHSL-63-SYM AND PHS-63-SYM PEDIATRIC HEAD AND SPINE ARRAY COILS MRI DEVICES CORP. 510(k) NO: K024354(SPECIAL) ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402 1515 PARAMOUNT DR. SE DECISION MADE: 09-JAN-03 WAUKESHA, WI 53186 510(k) STATEMENT DEVICE: IMPULSE-ADJUSTING INSTRUMENT, CBP ADJUSTING INSTRUMENT, NEUROMEC NEUROMECHANICAL INNOVATIONS, LLC 510(k) NO: K023462(TRADITIONAL) ATTN: CHRISTOPHER J COLLOCA PHONE NO : 480-893-2400 11011 S. 48TH ST SE DECISION MADE: 13-JAN-03 SUITE 205 510(k) SUMMARY AVAILABLE FROM FDA PHOENIX, AZ 85044 DEVICE: NUAMPS NEUROSCAN 510(k) NO: K023536(ABBREVIATED) ATTN: ELVIRA GARCIA PHONE NO : 915-845-5600 7850 PASEO DEL NORTE SE DECISION MADE: 15-JAN-03 SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA EL PASO, TX 79912 DEVICE: NIKOMED TRACE 1 ECG ELECTRODES NIKOMED U.S.A., INC. 510(k) NO: K022909(SPECIAL) ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035 P.O. BOX 560 SE DECISION MADE: 09-JAN-03 STILLWATER, MN 55082 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPLACE ONE PIECE IMPLANT, HA, REPLACE ONE PIECE IMPLANT, TIUNIT NOBEL BIOCARE USA, INC. 510(k) NO: K023952(TRADITIONAL) ATTN: KATHELEEN DRAGOVICH PHONE NO : 714-282-4800 22715 SAVI RANCH PKWY. SE DECISION MADE: 16-JAN-03 YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0 NORTHGATE TECHNOLOGIES, INC. 510(k) NO: K022052(TRADITIONAL) ATTN: CASEY KUREK PHONE NO : 847-608-8900 600 CHURCH RD. SE DECISION MADE: 24-JAN-03 ELGIN, IL 60123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LAD, MODEL LAD-01 NORWOOD ABBEY , LTD. 510(k) NO: K021222(TRADITIONAL) ATTN: ROBERT HANDREN PHONE NO : 352-314-8829 5818 PRINCESS CAROLINE PLACE SE DECISION MADE: 08-JAN-03 LEESBURG, FL 34748 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENCLOSE ANASTOMOSIS ASSIST DEVICE NOVARE SURGICAL SYSTEMS, INC. 510(k) NO: K023682(TRADITIONAL) ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640 200 GREGORY LANE SE DECISION MADE: 16-JAN-03 SUITE C-100 510(k) SUMMARY AVAILABLE FROM FDA PLEASANT HILL, CA 94523-3389 DEVICE: VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V OLYMPUS OPTICAL CO., LTD. 510(k) NO: K022445(TRADITIONAL) ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688 TWO CORPORATE CENTER DRIVE SE DECISION MADE: 24-JAN-03 MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: A-SCAN 100 OPHTHALMIC TECHNOLOGIES, INC. 510(k) NO: K024114(SPECIAL) ATTN: GEORGE H MYERS PHONE NO : 201-727-1703 377 RT 17 S SE DECISION MADE: 10-JAN-03 HASBROUCK HEIGHTS, NJ 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS ORTHO-CLINICAL DIAGNOSTICS 510(k) NO: K030067(TRADITIONAL) ATTN: SARAH PARSONS PHONE NO : 585-453-3154 100 INDIGO CREEK DRIVE SE DECISION MADE: 17-JAN-03 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB OSCOR INC. 510(k) NO: K024053(SPECIAL) ATTN: MILA DOSKOCIL PHONE NO : 727-937-2511 3816 DE SOTO BLVD. SE DECISION MADE: 31-JAN-03 PALM HARBOR, FL 34683 510(k) STATEMENT DEVICE: PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/ OSCOR INC. 510(k) NO: K024156(SPECIAL) ATTN: MILA DOSKOCIL PHONE NO : 727-937-2511 3816 DE SOTO BLVD. SE DECISION MADE: 14-JAN-03 PALM HARBOR, FL 34683 510(k) STATEMENT DEVICE: OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV) OSMETECH 510(k) NO: K023677(TRADITIONAL) ATTN: ANDREW TUMMON PHONE NO : 440 127 0216444 ELECTRA HOUSE ELECTRA WAY SE DECISION MADE: 29-JAN-03 CREWE, UNITED KINGDOM 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORB OSTEOMEDICS, INC. 510(k) NO: K022035(TRADITIONAL) ATTN: ALBERT ENYATI PHONE NO : 201-444-7306 809 CARTER LANE SE DECISION MADE: 17-JAN-03 PARAMUS, NJ 07652 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONICAID ONE OXFORD INSTRUMENTS MEDICAL LTD. 510(k) NO: K023618(SPECIAL) ATTN: MICHAEL EDWARDS PHONE NO : 44 148 3246277 MANOR WAY SE DECISION MADE: 22-JAN-03 OLD WOKING, SURREY, UNITED KINGDOM510(k) STATEMENT DEVICE: PALOMAR Q-YAG ND:YAG LASER SYSTEM PALOMAR MEDICAL TECHNOLOGIES, INC.510(k) NO: K023967(TRADITIONAL) ATTN: MARCY MOORE PHONE NO : 919-363-2432 131 KELEKENT LANE SE DECISION MADE: 27-JAN-03 CARY, NC 27511 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GOLD CORE PLUS PENTRON LABORATORY TECHNOLOGIES 510(k) NO: K023499(TRADITIONAL) ATTN: ANNMARIE TENERO PHONE NO : 203-265-7397 53 NORTH PLAINS INDUSTRIAL RD. SE DECISION MADE: 13-JAN-03 WALLINGFORD, CT 06492-0724 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCULPTURE PLUS NANO-HYBRID COMPOSITE PENTRON LABORATORY TECHNOLOGIES 510(k) NO: K023742(TRADITIONAL) ATTN: ANNMARIE TENERO PHONE NO : 203-265-7397 53 NORTH PLAINS INDUSTRIAL RD. SE DECISION MADE: 17-JAN-03 WALLINGFORD, CT 06492-0724 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE COATED NITRILE EXAMINATION GLOVE, BLUE COLORED PERUSAHAAN GETAH ASAS SDN BHD 510(k) NO: K024184(TRADITIONAL) ATTN: JAMES F LOGAN PHONE NO : 410-837-1751 1301 DEFENCE HIGHWAY SE DECISION MADE: 14-JAN-03 GAMBRILLS, MD 21054 510(k) STATEMENT DEVICE: ACCURA ELITE SHUNT SYSTEM PHOENIX BIOMEDICAL CORP. 510(k) NO: K024040(SPECIAL) ATTN: COURTNEY SMITH PHONE NO : 610-539-9300 2495 GENERAL ARMISTEAD AVE. SE DECISION MADE: 27-JAN-03 P.O. BOX 80390 510(k) SUMMARY AVAILABLE FROM FDA NORRISTOWN, PA 19403 DEVICE: PHOENIX UNIVERSAL SHUNT SYSTEM PHOENIX BIOMEDICAL CORP. 510(k) NO: K024101(SPECIAL) ATTN: COURTNEY SMITH PHONE NO : 610-539-9300 2495 GENERAL ARMSTEAD AVE. SE DECISION MADE: 27-JAN-03 NORRISTOWN, PA 19403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PICUS ULTRASOUND IMAGING SYSTEMS PIE MEDICAL 510(k) NO: K023512(TRADITIONAL) ATTN: COLLEEN DENSMORE PHONE NO : 317-849-1916 SE DECISION MADE: 24-JAN-03 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNI HIP STEM PLUS ORTHOPEDICS 510(k) NO: K024134(SPECIAL) ATTN: J.D. WEBB PHONE NO : 512-388-0199 1001 OAKWOOD BLVD SE DECISION MADE: 15-JAN-03 ROUND ROCK, TX 78681-2700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRECIMED HIP SCREW SYSTEM PRECIMED, INC. 510(k) NO: K023851(TRADITIONAL) ATTN: BARBARA LYONS PHONE NO : 610-524-8300 50 DEVYN DR. SE DECISION MADE: 28-JAN-03 CHESTER SPRINGS, PA 19425 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UCC DENTAL MATERIAL PRECIOUS CHEMICALS U.S.A., INC. 510(k) NO: K023790(TRADITIONAL) ATTN: EUGENE LIEBERSTEIN PHONE NO : 203-329-1477 2151 LONG RIDGE RD. SE DECISION MADE: 21-JAN-03 STAMFORD, CT 06903 510(k) STATEMENT DEVICE: UCP DENTAL MATERIAL PRECIOUS CHEMICALS U.S.A., INC. 510(k) NO: K023831(TRADITIONAL) ATTN: EUGENE LIEBERSTEIN PHONE NO : 203-329-1477 2151 LONG RIDGE RD. SE DECISION MADE: 24-JAN-03 STAMFORD, CT 06903 510(k) STATEMENT DEVICE: GAS SAMPLING LINES PROMEDIC, INC. 510(k) NO: K023579(TRADITIONAL) ATTN: PAUL DRYDEN PHONE NO : 317-335-3780 6329 WEST WATERVIEW CT. SE DECISION MADE: 28-JAN-03 MCCORDSVILLE, IN 46055-9501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIRIDIS TWIN OPHTHALMIC PHOTOCOAGULATOR QUANTEL MEDICAL 510(k) NO: K023464(TRADITIONAL) ATTN: ROGER W BARNES PHONE NO : 501-525-8612 342 SUNSET BAY ROAD SE DECISION MADE: 13-JAN-03 HOT SPRINGS, AR 71913 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RADIOMED MARKER RADIOMED CORPORATION 510(k) NO: K022326(TRADITIONAL) ATTN: GORDON ROBERTS PHONE NO : 978-649-0300 ONE INDUSTRIAL WAY SE DECISION MADE: 31-JAN-03 TYNGSBORO, MA 01879-1400 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RADIONICS VARILINK 2 RADIONICS, A DIVISION OF TYCO HEAL510(k) NO: K023519(TRADITIONAL) ATTN: KEVIN J O'CONNELL PHONE NO : 781-272-1233 22 TERRY AVE. SE DECISION MADE: 16-JAN-03 BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTR RANDOX LABORATORIES, LTD. 510(k) NO: K023763(TRADITIONAL) ATTN: LYNNE HAMILTON PHONE NO : 440 289 4422413 ARDMORE, DIAMOND ROAD SE DECISION MADE: 13-JAN-03 CRUMLIN, CO. ANTRIM, UNITED KINGDO510(k) STATEMENT DEVICE: LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING H REHABILITATION INSTITUTE,LOMA LIND510(k) NO: K023572(TRADITIONAL) ATTN: LYNN D FLEISHER PHONE NO : 312-853-2065 BANK ONE PLAZA, 10 S. DEARBORN SE DECISION MADE: 13-JAN-03 CHICAGO, IL 60603 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REMECURE MODEL CL 15E REMEDENT NV 510(k) NO: K023652(TRADITIONAL) ATTN: ED FIRST PHONE NO : 949-421-0120 20992 BAKE PKWY SE DECISION MADE: 09-JAN-03 UNIT 102 510(k) STATEMENT LAKE FOREST, CA 92692 DEVICE: IMAGE3 SE DISPOSABLE FULL FACE MASK RESPIRONICS, INC. 510(k) NO: K023135(ABBREVIATED) ATTN: ZITA A YURKO PHONE NO : 724-387-4120 1001 MURRY RIDGE LANE SE DECISION MADE: 03-JAN-03 MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: H2 HEATED HUMIDIFIER RESPIRONICS, INC. 510(k) NO: K030090(TRADITIONAL) ATTN: ZITA A YURKO PHONE NO : 724-387-4120 1001 MURRY RIDGE LANE SE DECISION MADE: 24-JAN-03 MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: INNER-LOCK LOCKING INTRODUCER SHEATHS REX MEDICAL 510(k) NO: K022170(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001 55 NORTHERN BLVD. SE DECISION MADE: 21-JAN-03 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 11021 DEVICE: 1-CCD ENDOCAM 5520 SYSTEM RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K023659(TRADITIONAL) ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113 353 CORPORATE WOODS PKWY. SE DECISION MADE: 29-JAN-03 VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIPOLAR FORCEPS RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K023813(TRADITIONAL) ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113 353 CORPORATE WOODS PKWY. SE DECISION MADE: 17-JAN-03 VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BICARBONATE DIALYSATE CONCENTRATE MIXER, MODEL 50 GALLON & 100 G ROCKWELL MEDICAL TECHNOLOGIES, INC510(k) NO: K022521(TRADITIONAL) ATTN: DONALD DANALD PHONE NO : 248-960-9009 30142 WIXOM ROAD SE DECISION MADE: 03-JAN-03 WIXOM, MI 48393 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30 RUBICOR MEDICAL, INC. 510(k) NO: K030049(SPECIAL) ATTN: ROBERT J CHIN PHONE NO : 650-593-5225 25 HARTFORD AVENUE SE DECISION MADE: 29-JAN-03 SAN CARLOS, CA 94070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAS RSV TEST SA SCIENTIFIC, INC. 510(k) NO: K022845(TRADITIONAL) ATTN: RICARDO R MARTINEZ PHONE NO : 210-699-8800 4919 GOLDEN QUAIL SE DECISION MADE: 29-JAN-03 SAN ANTONIO, TX 78240 510(k) STATEMENT DEVICE: DISPOSBLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA SAFEHEALTH MEDICAL SUPPLY CORP. 510(k) NO: K024081(TRADITIONAL) ATTN: P.M. YEH PHONE NO : 011 886 67832197 NO. 1,TOU KANG LI, SE DECISION MADE: 28-JAN-03 HSUEH CHIA COUNTY 510(k) STATEMENT TAINAN HSIEN, CHINA (TAIWAN) DEVICE: NEOGENESYS 2K SANEXAS INTL. GMBH 510(k) NO: K022433(TRADITIONAL) ATTN: GENE KELLY PHONE NO : 816-347-9224 200 NE MULBERRY SE DECISION MADE: 24-JAN-03 LEE'S SUMMIT, MO 64086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRE-POWDERED LATEX SURGEON'S GLOVES SANREA HEALTHCARE PRIVATE LIMITED 510(k) NO: K023515(TRADITIONAL) ATTN: JOSE PAUL M PHONE NO : 91 484 422514 COCHIN SPECIAL ECONOMIC ZONE SE DECISION MADE: 16-JAN-03 KAKKANAD, COCHIN 510(k) STATEMENT KERALA, INDIA 682037 DEVICE: BIOSORB RESORBABLE VOID FILLER SCIENCES ET BIO MATERIAUX (SBM) 510(k) NO: K021963(TRADITIONAL) ATTN: DENIS CLEMENT PHONE NO : 335 624 22101 ZI DU MONGE SE DECISION MADE: 28-JAN-03 LORDES, FRANCE F 65100 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G SECHRIST INDUSTRIES, INC. 510(k) NO: K023745(TRADITIONAL) ATTN: GREG GODFREY PHONE NO : 714-579-8318 4225 EAST LA PALMA SE DECISION MADE: 17-JAN-03 ANAHEIM, CA 92807 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM SECURE SCIENTIFIC SDN BHD 510(k) NO: K023128(ABBREVIATED) ATTN: CHONG NGIT-HENG PHONE NO : 604 484 3987 LOT 122, KAMPUNG TITI TOK ARIS SE DECISION MADE: 22-JAN-03 SUNGAI SELUANG 510(k) STATEMENT LUNAS, KEDAH, MALAYSIA 09600 DEVICE: PEGASUS NASAL CPAP SYSTEM SENSORMEDICS CORP. 510(k) NO: K022192(TRADITIONAL) ATTN: PAUL L KITTINGER PHONE NO : 714-283-2228 22705 SAVI RANCH PKWY. SE DECISION MADE: 24-JAN-03 YORBA LINDA, CA 92887-4645 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACROSEAL ROOT CANAL OR APICAL SEALER SEPTODONT S.A.S. 510(k) NO: K023976(TRADITIONAL) ATTN: WAYNE H MATELSKI PHONE NO : 202-857-6340 1050 CONNECTICUT AVE NW SE DECISION MADE: 30-JAN-03 WASHINGTON, DC 20036 510(k) STATEMENT DEVICE: SHANGHAI HUAMAO POWDER-FREE YELLOW VINYL EXAM GLOVES SHANGHAI HUAMAO GLOVES CO., LTD. 510(k) NO: K024154(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001 55 NORTHERN BLVD. SUITE 200 SE DECISION MADE: 06-JAN-03 GREAT NECK, NY 11021 510(k) STATEMENT DEVICE: SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM SMITH & NEPHEW, INC. 510(k) NO: K023743(ABBREVIATED) ATTN: JANET JOHNSON AKIL PHONE NO : 901-399-5153 1450 E. BROOKS ROAD SE DECISION MADE: 23-JAN-03 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SODEM HIGH SPEED SYSTEM (PNEUMATIC) SODEM SYSTEMS 510(k) NO: K023070(TRADITIONAL) ATTN: CAROLE BURNIER PHONE NO : 41 22 7949696 110 CH. DU PONT DU CENTENAIRE SE DECISION MADE: 28-JAN-03 GENEVA, SWITZERLAND CH-1228 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUSOFT SPHERICAL, TORIC, ASPHERIC AND BIFOCAL (OCUFILCON B) SOFT SOFTFOCAL COMPANY, INC. 510(k) NO: K023791(TRADITIONAL) ATTN: ROBERT B MANDELL PHONE NO : 925-376-4724 69 SULLIVAN DRIVE SE DECISION MADE: 10-JAN-03 MORAGA, CA 94556 510(k) STATEMENT DEVICE: HCP DICOM NET SOFTLINK INTERNATIONAL INC. 510(k) NO: K023467(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511 55 NORTHERN BLVD SE DECISION MADE: 07-JAN-03 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 11021 DEVICE: SOLA, COUNTER-PULSATION, MODEL SECP-S SOLA MEDICAL DEVICES, LLC 510(k) NO: K022078(TRADITIONAL) ATTN: GREG HOLLAND PHONE NO : 949-262-0411 3722 AVE SAUSALITO SE DECISION MADE: 10-JAN-03 IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY SONOSITE,INC. 510(k) NO: K030064(TRADITIONAL) ATTN: MICHAEL A HOFFMAN PHONE NO : 425-951-1297 21919 30TH DRIVE SE. SE DECISION MADE: 22-JAN-03 BOTHELL, WA 98021-3904 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MBC SERIES SORING GMBH MEDIZINTECHNIK 510(k) NO: K024059(SPECIAL) ATTN: CARL ALLETTO PHONE NO : 214-262-4209 1100 LAKEVIEW BLVD. SE DECISION MADE: 08-JAN-03 DENTON, TX 76208 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CPC BY SORING GMBH SORING GMBH MEDIZINTECHNIK 510(k) NO: K030028(SPECIAL) ATTN: CARL ALLETTO PHONE NO : 214-262-4209 1100 LAKEVIEW BLVD. SE DECISION MADE: 17-JAN-03 DENTON, TX 76208 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPECATH CENTRAL VENOUS CATHETER KITS SPECIAL MEDICAL CO. LTD. 510(k) NO: K021130(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001 55 NORTHERN BLVD. SE DECISION MADE: 07-JAN-03 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 11021 DEVICE: SPINAL CONCEPTS, INC. ANT-CER DYNAMIC ANTERIOR CERVICAL PLATE SY SPINAL CONCEPTS, INC. 510(k) NO: K024326(SPECIAL) ATTN: LISA PETERSON PHONE NO : 512-918-2700 5301 RIATA PARK COURT SE DECISION MADE: 23-JAN-03 BLDG F 510(k) SUMMARY AVAILABLE FROM FDA AUSTIN, TX 78727 DEVICE: PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLA STARMATRIX SDN BHD 510(k) NO: K023977(TRADITIONAL) ATTN: NGAN BOON SENG PHONE NO : 603 339 26168 10, JALAN SS 1/26 SE DECISION MADE: 24-JAN-03 PETALING JAYA, SELANGOR, MALAYSIA 510(k) STATEMENT DEVICE: NITRILE EXAMINATION GLOVES, POWDER FREE STARMATRIX SDN BHD 510(k) NO: K023978(TRADITIONAL) ATTN: NGAN BOON SENG PHONE NO : 603 339 26168 10, JALAN SS 1/26 SE DECISION MADE: 24-JAN-03 PETALING JAYA, SELANGOR, MALAYSIA 510(k) STATEMENT DEVICE: NITRILE EXAMINATION GLOVES, PRE-POWDERED STARMATRIX SDN BHD 510(k) NO: K023979(TRADITIONAL) ATTN: NGAN GOON SENG PHONE NO : 603 339 26168 10, JALAN SS 1/26 SE DECISION MADE: 24-JAN-03 PETALING JAYA, SELANGOR, MALAYSIA 510(k) STATEMENT DEVICE: STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM STEREOTAXIS, INC. 510(k) NO: K021555(TRADITIONAL) ATTN: PETER A TAKES PHONE NO : 314-615-6964 4041 FOREST PARK AVENUE SE DECISION MADE: 15-JAN-03 ST. LOUIS, MO 63108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERNGOLD ACID ETCH DENTAL IMPLANT SYSTEM STERNGOLD 510(k) NO: K023580(ABBREVIATED) ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552 5 WHITCOMB AVENUE SE DECISION MADE: 17-JAN-03 AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER NAVIGATION SYSTEM - HIP MODULE STRYKER INSTRUMENTS 510(k) NO: K022365(TRADITIONAL) ATTN: KELLI BITTERBURG PHONE NO : 616-323-7700 4100 EAST MILHAM AVE. SE DECISION MADE: 22-JAN-03 KALAMAZOO, MI 49001-6197 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NON-INVASIVE PATIENT FIXATION SYSTEM STRYKER LEIBINGER 510(k) NO: K023449(TRADITIONAL) ATTN: KELLI J BITTERBURG PHONE NO : 877-534-2464 4100 EAST MILHAM AVE SE DECISION MADE: 13-JAN-03 KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFEDOP DOPPLER SUMMIT DOPPLER SYSTEMS, INC. 510(k) NO: K024197(TRADITIONAL) ATTN: KEN JARRELL PHONE NO : 303-423-7572 5350 VIVIAN ST., SUITE A SE DECISION MADE: 03-JAN-03 ARVADA, CO 80002-1957 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: GREEN POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH PEPPER SUPERMAX GLOVE MANUFACTURING SDN B510(k) NO: K024083(TRADITIONAL) ATTN: STANLEY THAI PHONE NO : 603 615 72328 LOT 42, PUTRA INDUSTRIAL PARK SE DECISION MADE: 10-JAN-03 BUKIT RAHMAN PUTRA 510(k) STATEMENT SUNGAI BULOH, SELANGOR, MALAYSIA 47000 DEVICE: MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES SURGICAL INSTRUMENTS SERVICE AND S510(k) NO: K030179(ABBREVIATED) ATTN: MARY ANN BARKER PHONE NO : 541-549-4164 723 CURTIS CT; PO BOX 2060 SE DECISION MADE: 24-JAN-03 SISTERS, OR 97759 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SLT VENOUS FIBER DELIVERY SYSTEMS, MODEL: 0041-6772/0041-6781/00 SURGICAL LASER TECHNOLOGIES, INC. 510(k) NO: K023624(TRADITIONAL) ATTN: DAVIS WOODWARD PHONE NO : 215-619-3600 147 KEYSTONE DR. SE DECISION MADE: 27-JAN-03 MONTGOMERYVILLE, PA 18936 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE-BLUE COLOR SYNTEX HEALTHCARE PRODUCTS CO. LTD510(k) NO: K023826(TRADITIONAL) ATTN: TAN SWU CHOON PHONE NO : 863 113 270666 NO. 1 FANJIAZHUNG INDUSTRIAL SE DECISION MADE: 24-JAN-03 ZONE 510(k) STATEMENT XINJI CITY, HEBEI PROVINCE, CHINA 052360 DEVICE: SYNTHES RESORBABLE CONTOURABLE MESH SYNTHES (USA) 510(k) NO: K022844(TRADITIONAL) ATTN: MATTHEW M HULL PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 07-JAN-03 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES 4.5 MM TITANIUM LCP PROXIMAL TIBIA PLATING SYSTEM SYNTHES (USA) 510(k) NO: K023802(TRADITIONAL) ATTN: LISA M BOYLE PHONE NO : 610-647-9700 1690 RUSSELL ROAD SE DECISION MADE: 28-JAN-03 POST OFFICE BOX 1766 510(k) SUMMARY AVAILABLE FROM FDA PAOLI, PA 19301 DEVICE: SYNTHES TOMOFIX OSTEOTOMY SYSTEM SYNTHES (USA) 510(k) NO: K023941(TRADITIONAL) ATTN: LISA M BOYLE PHONE NO : 610-647-9700 1690 RUSSELL ROAD SE DECISION MADE: 23-JAN-03 POST OFFICE BOX 1766 510(k) SUMMARY AVAILABLE FROM FDA PAOLI, PA 19301 DEVICE: TATUNG TMD-26AX SERIES TENS, MODELS NO. TMD-26AB TATUNG TENS (BL TATUNG CO. 510(k) NO: K021794(TRADITIONAL) ATTN: JENNIFER REICH PHONE NO : 928-773-9488 3892 SOUTH AMERICA WEST TRAIL SE DECISION MADE: 13-JAN-03 FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TEH LIN JUPITER POWER CHAIR, MODEL TL-320 TEH LIN PROSTHETIC & ORTHOPAEDIC, 510(k) NO: K022697(TRADITIONAL) ATTN: KE-MIN JEN PHONE NO : 886 3 5208829 NO. 58, FU-CHIUN ST. SE DECISION MADE: 24-JAN-03 HSIN CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TERABYTE 2000 HAIR REMOVER TERABYTE CO. 510(k) NO: K022341(TRADITIONAL) ATTN: WILLIAM A OLSON PHONE NO : 703-590-7337 5200 WOLF RUN SHOALS ROAD SE DECISION MADE: 27-JAN-03 WOODBRIDGE, VA 22192 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TERASON MODEL 2000/BAS PORTABLE ULTRASOUND SYSTEM TERATECH CORP. 510(k) NO: K030191(TRADITIONAL) ATTN: CHARLES F HOTTINGER PHONE NO : 408-741-1006 77-79 TERRACE HALL AVE. SE DECISION MADE: 29-JAN-03 BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: TRILUMINA THERAPEUTIC LASER SYSTEM TEXAS APPLIED BIOMEDICAL SERVICES 510(k) NO: K023935(TRADITIONAL) ATTN: M. JOYCE HEINRICH PHONE NO : 713-734-4433 12101-A CULLEN BLVD. SE DECISION MADE: 28-JAN-03 HOUSTON, TX 77047 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FREELITE HUMAN KAPPA AND HUMAN LAMBDA FREE KITS FOR USE ON THE H THE BINDING SITE, LTD. 510(k) NO: K023009(TRADITIONAL) ATTN: JAY H GELLER PHONE NO : 310-449-1399 EAST TOWER, SUITE 600 SE DECISION MADE: 21-JAN-03 2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT SANTA MONICA, CA 90404 DEVICE: FREELITE HUMAN LAMBDA FREE KIT THE BINDING SITE, LTD. 510(k) NO: K023131(TRADITIONAL) ATTN: JAY H GELLER PHONE NO : 310-449-1399 WEST TOWER, SUITE 4000 SE DECISION MADE: 21-JAN-03 2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT SANTA MONICA, CA 90404 DEVICE: MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIE THE OLYMPUS OPTICAL CO. 510(k) NO: K023984(TRADITIONAL) ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688 TWO CORPORATE DRIVE SE DECISION MADE: 31-JAN-03 MELVILLE, NY 11747 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM THERALIGHT, INC. 510(k) NO: K024020(TRADITIONAL) ATTN: KEVIN E DALY PHONE NO : 760-930-8000 2794 LOKER AVE. WEST,SUITE 105 SE DECISION MADE: 17-JAN-03 CARLSBAD, CA 92008-6616 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RSV OIA THERMO BIOSTAR, INC. 510(k) NO: K023779(TRADITIONAL) ATTN: JOHN G ADAMS PHONE NO : 303-530-3888 331 SOUTH 104TH STREET SE DECISION MADE: 14-JAN-03 LOUISVILLE, CO 80027 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CALIBRATION PACK, MODELS A9100-101S AND A9100-103S THERMO ORION 510(k) NO: K023792(TRADITIONAL) ATTN: PATRICK K CHIU PHONE NO : 978-232-1067 500 CUMMINGS CENTER SE DECISION MADE: 31-JAN-03 BEVERLY, MA 01915-6199 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TROPHYPAN TROPHY RADIOLOGIE 510(k) NO: K023346(TRADITIONAL) ATTN: MARIE-PIERRE LABAT-CAMY PHONE NO : 331 648 08500 4 RUE F. PELLOUTIER CROISSY SE DECISION MADE: 03-JAN-03 BEAUBOURG 510(k) STATEMENT MARNE LA VALLEE CEDEX 2, FRANCE 77437 DEVICE: ULTROID HEMORRHOID MANAGEMENT SYSTEM ULTROID, LLC 510(k) NO: K023706(TRADITIONAL) ATTN: RONALD R NEWTON PHONE NO : 775-841-4333 2230 DAMON RD. SE DECISION MADE: 14-JAN-03 CARSON CITY, NV 89701 510(k) STATEMENT DEVICE: UNIPACS WORKSTATION UNIVERSAL PACS, INC. 510(k) NO: K023476(TRADITIONAL) ATTN: JOHN M TYLER PHONE NO : 225-766-9381 127 ALBERT HART DRIVE SE DECISION MADE: 07-JAN-03 BATON ROUGE, LA 70803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PLEVIS COIL USA INSTRUMENTS, INC. 510(k) NO: K023650(TRADITIONAL) ATTN: CHRISTIE SHUMAKER PHONE NO : 330-562-1000 1515 DANNER DRIVE SE DECISION MADE: 24-JAN-03 AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BURBANK TENACULUM, MODEL 09-0011-01 VASCULAR CONTROL SYSTEMS, INC 510(k) NO: K030078(TRADITIONAL) ATTN: AL MEMMOLO PHONE NO : 949-488-8700 32236 PASEO ADELANTO, STE. E SE DECISION MADE: 24-JAN-03 SAN JUAN CAPISTRANO, CA 92675 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MODIFICATION TO VISION SCIENCES ENDOSHEATH SYSTEM VISION-SCIENCES, INC. 510(k) NO: K024095(SPECIAL) ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552 5 WHITCOMB AVENUE SE DECISION MADE: 09-JAN-03 AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BOUSSIGNAC C.P.A.P. DEVICE VYGON S A 510(k) NO: K013884(TRADITIONAL) ATTN: LAETITIA BERNARD PHONE NO : 909-699-6262 45900 PARSIPPANY COURT SE DECISION MADE: 21-JAN-03 TEMECULA, CA 92592 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APEX 90 WE DONG MYUNG DENTAL INDUSTRIAL CO510(k) NO: K030206(TRADITIONAL) ATTN: RONALD D ARKIN PHONE NO : 770-565-6166 1733 CANTON LANE SE DECISION MADE: 29-JAN-03 MARIETTA, GA 30062 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271 WIENER LABORATORIES S.A.I.C. 510(k) NO: K023744(TRADITIONAL) ATTN: VIVIANA CETOLA PHONE NO : 54 341 4329191 2944 RIOBAMBA SE DECISION MADE: 03-JAN-03 ROSARIO, ARGENTINA 2000 510(k) STATEMENT DEVICE: ENDOSCOPIC LIGHT SOURCE XL180/L3 WORLD OF MEDICINE LEMKE GMBH 510(k) NO: K023468(TRADITIONAL) ATTN: SUSANNE RAAB PHONE NO : 617-868-3995 91 TROWBRIDGE STREET SE DECISION MADE: 14-JAN-03 CAMBRIDGE, MA 02138 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES WITH SKIN-CARE WRP ASIA PACIFIC SDN. BHD. 510(k) NO: K023490(TRADITIONAL) ATTN: YUE WAH CHOW PHONE NO : 60 3 87061486 LOT 1, JALAN 3, SE DECISION MADE: 16-JAN-03 KAWASAN PERUSAHAAN BANDAR BARU 510(k) SUMMARY AVAILABLE FROM FDA SALAK TINGGI, SEPANG SELANGOR, MALAYSIA 43900 DEVICE: WU'S 3-WHEELED NEO SCOOTER, WT-L3 WU'S TECH CO., LTD. 510(k) NO: K023040(TRADITIONAL) ATTN: JEN KE-MIN PHONE NO : 866 352 08829 NO. 58, FU-CHIUN ST. SE DECISION MADE: 24-JAN-03 HSIN-CHU CITY, CHINA (TAIWAN) ROC 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WU'S 3-WHEELED NEO SCOOTER, WT-M4 WU'S TECH CO., LTD. 510(k) NO: K023166(TRADITIONAL) ATTN: JEN KE-MIN PHONE NO : 886 352 08829 NO. 58, FU-CHIUN ST. SE DECISION MADE: 24-JAN-03 HSIN-CHU CITY, CHINA (TAIWAN) ROC 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WU'S 3-WHEELED NEO SCOOTER, WT-T3B WU'S TECH CO., LTD. 510(k) NO: K023168(TRADITIONAL) ATTN: JEN KE-MIN PHONE NO : 886 352 08829 NO. 58, FU-CHIUN ST. SE DECISION MADE: 24-JAN-03 NSIN-CHU CITY, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAYBE?MOM MINI PVULATION MICROSCOPE LEC ASSOCIATES 510(k) NO: K013582 ATTN: TONI MILLER PHONE NO : 201-785-1882 22 CHURCH STREET SE DECISION MADE: 16-JAN-03 SUITE 103-224 510 (k) STATEMENT RAMSEY, NJ 07446 TOTAL 510(k)s THIS PERIOD 297 TOTAL WITH SUMMARIES 222 TOTAL WITH STATEMENTS 75
Updated 4/28/2004
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