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510(k)s Final Decisions Rendered for March 2001 |
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SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-MAR-2001 THROUGH 31-MAR-2001 DEVICE: 3M LITTMANN 3M COMPANY 510(k) NO: K003723(ABBREVIATED) ATTN: LINDA JOHNSEN PHONE NO : 651-737-4376 3M CENTER, BUILDING 275-5W-06 SE DECISION MADE: 27-MAR-01 ST. PAUL, MN 55144-1000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL BLOOD PRESSURE MONITORS, MODELS TM-2655, TM-2655P, & TM- A & D ENGINEERING, INC. 510(k) NO: K010828(TRADITIONAL) ATTN: JERRY WANG PHONE NO : 408-263-5333 1555 MC CANDLESS DR. SE DECISION MADE: 29-MAR-01 MILPITAS, CA 95035 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: 3D-DOCTOR ABLE SOFTWARE CORP. 510(k) NO: K003746(TRADITIONAL) ATTN: YECHENG WU PHONE NO : 781-862-2804 5 APPLETREE LANE SE DECISION MADE: 13-MAR-01 LEXINGTON, MA 02420-2406 510(k) STATEMENT DEVICE: ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS ACIST MEDICAL SYSTEMS, INC. 510(k) NO: K010390(SPECIAL) ATTN: CARL M BEAURLINE PHONE NO : 612-941-3507 7450 FLYING CLOUDS DR. SE DECISION MADE: 09-MAR-01 SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA EDEN PRAIRIE, MN 55344 DEVICE: ACON THC ONE STEP MARIJUANA TEST STRIP(URINE);ACON THC ONE STEP ACON LABORATORIES, INC. 510(k) NO: K003557(TRADITIONAL) ATTN: NORA C.R. YORK PHONE NO : 858-535-2030 11175 FLINTKOTE AVE., #F SE DECISION MADE: 15-MAR-01 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FS ACTIVATOR III ACTIVATOR METHODS INTERNATIONAL, L510(k) NO: K003185(TRADITIONAL) ATTN: ARLAN W FUHR PHONE NO : 602-224-0220 3714 EAST INDIAN SCHOOL RD. SE DECISION MADE: 20-MAR-01 PHOENIX, AZ 85018 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MRI SAFE INSTRUMENTS AESCULAP, INC. 510(k) NO: K003965(TRADITIONAL) ATTN: LISA M MILLINGTON PHONE NO : 800-258-1946 944 MARCON BLVD SE DECISION MADE: 16-MAR-01 ALLENTOWN, PA 18109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADC QS/IPD WORKSTATION AGFA CORPORATION 510(k) NO: K010571(SPECIAL) ATTN: T. WHIT ATHEY PHONE NO : 301-770-9590 12300 TWINBROOK PKWY,STE 625 SE DECISION MADE: 28-MAR-01 ROCKVILLE, MD 20852 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: M2376A DEVICELINK SYSTEM AGILENT TECHNOLOGIES, INC. 510(k) NO: K010453(SPECIAL) ATTN: MIKE HUDON PHONE NO : 978-659-3173 3000 MINUTEMAN RD. SE DECISION MADE: 02-MAR-01 ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PPCID- PNEUMATIC PERIPHERAL CIRCULATION IMPROVEMENT (FOOTREST) D AHAVA STEIN 510(k) NO: K000655(TRADITIONAL) ATTN: AHAVA STEIN PHONE NO : 972 979 20673 P.O.B. 454 SE DECISION MADE: 26-MAR-01 GINOT SHOMRON, 44853, ISRAEL 510(k) STATEMENT DEVICE: BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT L AMERICAN CONTACT LENS, INC. 510(k) NO: K010223(TRADITIONAL) ATTN: MARTIN DALSING PHONE NO : 970-243-5490 623 GLACIER DRIVE SE DECISION MADE: 16-MAR-01 GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMS FASCIAL-ANCHORING SYSTEM AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K010277(TRADITIONAL) ATTN: ELSA LINKE PHONE NO : 800-328-3881 10700 BREN RD., WEST SE DECISION MADE: 26-MAR-01 MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 'ALL 2000' % OXYGEN ANALYZER ANALYTICAL INDUSTRIES INC. 510(k) NO: K002382(TRADITIONAL) ATTN: PATRICK J PRINDIBLE PHONE NO : 909-392-6900 2855 METROPOLITAN PLACE SE DECISION MADE: 14-MAR-01 POMONA, CA 91767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APEX MODULAR ZIRCONIA FEMORAL HEAD APEX SURGICAL, LLC 510(k) NO: K003923(TRADITIONAL) ATTN: EDWARD J CHEAL PHONE NO : 508-947-6500 12 HARDING STREET,SUITE 202 SE DECISION MADE: 20-MAR-01 LAKEVILLE, MA 02347 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VCF PERSONAL LUBRICANT APOTHECUS PHARMACEUTICAL CORP. 510(k) NO: K010182(TRADITIONAL) ATTN: GARY L YINGLING PHONE NO : 202-496-7645 1900 K STREET, N.W. SE DECISION MADE: 09-MAR-01 WASHINGTON, DC 20006-1108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APPLIED BIOTECH, INC. SURESTEP AMP II DRUG SCREEN TEST APPLIED BIOTECH, INC. 510(k) NO: K003466(TRADITIONAL) ATTN: DAVE D SMITH PHONE NO : 858-587-6771 10237 FLANDERS CT. SE DECISION MADE: 27-MAR-01 SAN DIEGO, CA 92121 510(k) STATEMENT DEVICE: BEAM BLOCK TRAYS ARPLAY MEDICAL S.A. 510(k) NO: K004015(TRADITIONAL) ATTN: RICHARD BORGI PHONE NO : 333 802 97401 1, ROUTE DE CITEAUX SE DECISION MADE: 13-MAR-01 IZEURE, COTE D'OR, FRANCE 21110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STYROFOAM CUTTERS FOR BLOCK CASTING SYSTEM ARPLAY MEDICAL S.A. 510(k) NO: K010062(TRADITIONAL) ATTN: RICHARD BORGI PHONE NO : 333 802 97401 1, ROUTE DE CITEAUX SE DECISION MADE: 13-MAR-01 IZEURE, COTE D'OR, FRANCE 21110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE P ARROW INTL., INC. 510(k) NO: K002507(TRADITIONAL) ATTN: THOMAS D NICKEL PHONE NO : 610-478-3137 2400 BERNVILLE RD. SE DECISION MADE: 21-MAR-01 READING, PA 19605 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARROW REDIGUARD, 9FR. 50CC, INTRA-AORTIC BALLOON VATHETER, IAB-R ARROW INTL., INC. 510(k) NO: K010330(SPECIAL) ATTN: WILLIAM PAQUIN PHONE NO : 617-389-6400 9 PLYMOUTH ST. SE DECISION MADE: 02-MAR-01 EVERETT, MA 02149 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARIS SITE MARKER ARTEMIS MEDICAL, INC. 510(k) NO: K003777(TRADITIONAL) ATTN: ROBIN BUSH PHONE NO : 650-286-2999 655 MARINERS ISLAND BLVD. SE DECISION MADE: 06-MAR-01 SUITE 303 510(k) SUMMARY AVAILABLE FROM FDA SAN MATEO, CA 94404 DEVICE: ARTHREX TITANIUM CORKSCREW, 3.5 MM, ARTHREX TITANIUM CORKSCREW, ARTHREX, INC. 510(k) NO: K003816(TRADITIONAL) ATTN: VERNON C BROWN PHONE NO : 941-643-5553 2885 SOUTH HORSESHOE DR. SE DECISION MADE: 09-MAR-01 NAPLES, FL 34104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHROCARE UROLOGY ELECTROSURGERY SYSTEM ARTHROCARE CORP. 510(k) NO: K010568(SPECIAL) ATTN: BETTY M JOHNSON PHONE NO : 408-736-0224 595 NORTH PASTORIA AVE. SE DECISION MADE: 27-MAR-01 SUNNYVALE, CA 94086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AXYA MEDICAL, INC. MODEL 1000 AXYALOOP BONE ANCHOR AXYA MEDICAL, INC. 510(k) NO: K003971(TRADITIONAL) ATTN: HOWARD L SCHRAYER PHONE NO : 609-924-9510 100 CUMMINGS CENTER SE DECISION MADE: 21-MAR-01 SUITE 444C 510(k) SUMMARY AVAILABLE FROM FDA BEVERLY, MA 01915 DEVICE: BAUMER CEMENTED HIP PROSTHESIS BAUMER S.A. 510(k) NO: K003975(TRADITIONAL) ATTN: BRENO C FARAGO PHONE NO : 551 938 063030 AV. PREF. ANTONIO TAVARES SE DECISION MADE: 19-MAR-01 LEITE NR: 181 510(k) STATEMENT MOGI MIRIM, SAO PAULO, BRAZIL 13800-000 DEVICE: BAUMER MULLER HIP PROSTHESIS BAUMER S.A. 510(k) NO: K003976(TRADITIONAL) ATTN: BRENO C FARAGO PHONE NO : 551 938 063030 AV. PREF. ANTONIO TAVARES SE DECISION MADE: 19-MAR-01 LEITE NR: 181 510(k) STATEMENT MOGI MIRIM, SAO PAULO, BRAZIL 13800-000 DEVICE: EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400 BAXA CORP. 510(k) NO: K002705(TRADITIONAL) ATTN: CARL STEINECK PHONE NO : 303-617-2181 13760 EAST ARAPAHOE RD. SE DECISION MADE: 28-MAR-01 ENGLEWOOD, CO 80112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C1-INHIBITOR MICROTITER ASSAY DEVICE BAXTER HEALTHCARE CORP. 510(k) NO: K003747(TRADITIONAL) ATTN: ARLENE VIDOR PHONE NO : 818-507-5523 550 NORTH BRAND BOULEVARD SE DECISION MADE: 19-MAR-01 GLENDALE, CA 91023 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BAYER ADVIA IMS SYSTEM BAYER CORP. 510(k) NO: K010201(TRADITIONAL) ATTN: FREDICK CLERIE PHONE NO : 914-524-3494 511 BENEDICT AVE. SE DECISION MADE: 29-MAR-01 TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE BD BECTON DICKINSON VACUTAINER SYS510(k) NO: K003553(TRADITIONAL) ATTN: GREGORY W MORGAN PHONE NO : 201-847-4344 1 BECTON DRIVE SE DECISION MADE: 21-MAR-01 MAIL CODE 226 510(k) SUMMARY AVAILABLE FROM FDA FRANKLIN LAKES, NJ 07417 DEVICE: BD ECLIPSE HYPODERMIC NEEDLE BD MEDICAL SYSTEMS 510(k) NO: K010188(TRADITIONAL) ATTN: GREG W MORGAN PHONE NO : 201-847-4344 1 BECTON DRIVE MC226 SE DECISION MADE: 01-MAR-01 FRANKLIN LAKES, NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIGIL SEROLOGY CONTROL LEVEL C BECKMAN COULTER, INC. 510(k) NO: K010358(TRADITIONAL) ATTN: ANNETTE HELLIE PHONE NO : 714-993-8767 200 SOUTH KRAEMER BLVD. SE DECISION MADE: 05-MAR-01 BREA, CA 92822 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCUTNI QC ON THE ACCESS IMMUNOASSAY SYSTEM #33349 BECKMAN COULTER, INC. 510(k) NO: K010428(TRADITIONAL) ATTN: BRENT TABER PHONE NO : 952-368-1323 1000 LAKE HAZELTINE DR. SE DECISION MADE: 13-MAR-01 CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD VISIDRAPE OPHTHALMIC DRAPES; BD VISIFLEX INCISE DRAPE BECTON DICKINSON AND COMPANY 510(k) NO: K010572(SPECIAL) ATTN: JAMES STAFFIERA PHONE NO : 941-359-7013 7575 COMMERCE COURT SE DECISION MADE: 12-MAR-01 SARASOTA, FL 34243-3212 510(k) STATEMENT DEVICE: BENZ-MF (VISIBILITY HANGLING TINT) (METHAFILCON A) SOFT DAILY WE BENZ RESEARCH AND DEVELOPMENT CORP510(k) NO: K003861(TRADITIONAL) ATTN: MARTIN DALSING PHONE NO : 970-243-5490 623 GLACIER DRIVE SE DECISION MADE: 08-MAR-01 GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FINGER PULSE METER BHS INTL., INC. 510(k) NO: K000814(TRADITIONAL) ATTN: CHRIS REDDING PHONE NO : 410-721-5055 2431 CROFTON LN., SUITE 9 SE DECISION MADE: 29-MAR-01 CROFTON, MD 21114 510(k) STATEMENT DEVICE: MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIG BINAX, INC. 510(k) NO: K010523(SPECIAL) ATTN: PAMELA S ANGELL PHONE NO : 207-772-3988 217 READ ST. SE DECISION MADE: 15-MAR-01 PORTLAND, ME 04103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING J BIOFILM, INC. 510(k) NO: K003867(TRADITIONAL) ATTN: ROBERT L DE ARMOND PHONE NO : 760-727-9030 3121 SCOTT ST. SE DECISION MADE: 09-MAR-01 VISTA, CA 92083 510(k) STATEMENT DEVICE: SEROJET BIOJECT, INC. 510(k) NO: K003908(TRADITIONAL) ATTN: NANCY J GERTLAR PHONE NO : 800-683-7221 7620 S.W. BRIDGEPORT RD. SE DECISION MADE: 08-MAR-01 PORTLAND, OR 97224 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTU BIOMEDICAL ENT., INC. 510(k) NO: K001353(TRADITIONAL) ATTN: W. CASEY FOX PHONE NO : 210-677-0354 14785 OMICRON DR., SUITE 205 SE DECISION MADE: 13-MAR-01 SAN ANTONIO, TX 78245 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEMOGRAPH; OSSTAPLE - ORTHOPEDIC USES FOR SMALL BONE AND FRAGMEN BIOMEDICAL ENT., INC. 510(k) NO: K001354(TRADITIONAL) ATTN: W. CASEY FOX PHONE NO : 210-677-0354 14785 OMICRON DR., SUITE 205 SE DECISION MADE: 13-MAR-01 SAN ANTONIO, TX 78245 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LACTOSORB 5.0 MM WASHER BIOMET, INC. 510(k) NO: K001581(TRADITIONAL) ATTN: CAROL LAUSTER PHONE NO : 219-372-1913 56 EAST BELL DRIVE SE DECISION MADE: 20-MAR-01 PO BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: PORTRAIT FEMORAL COMPONENT BIOMET, INC. 510(k) NO: K010560(SPECIAL) ATTN: MICHELLE L MCKINLEY PHONE NO : 219-372-1644 P.O. BOX 587 SE DECISION MADE: 20-MAR-01 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOSORBFX AND BIOSORBPDX MESH BIONX IMPLANTS, INC. 510(k) NO: K010687(SPECIAL) ATTN: TUIJA ANNALA PHONE NO : 358 331 65600 HERMIANKATU 6-8 L SE DECISION MADE: 14-MAR-01 TAMPERE, FINLAND FIN-33720 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STI BIOSAFE DIAGNOSTICS CORP. 510(k) NO: K003752(TRADITIONAL) ATTN: JACK A MAGGIORE PHONE NO : 773-693-0400 100 FIELD DRIVE SE DECISION MADE: 23-MAR-01 SUITE 240 510(k) SUMMARY AVAILABLE FROM FDA LAKE FOREST, IL 60045 DEVICE: TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000 BIOSITE DIAGNOSTICS 510(k) NO: K010266(TRADITIONAL) ATTN: JEFFREY R DAHLEN PHONE NO : 858-455-4808 11030 ROSELLE ST. SE DECISION MADE: 16-MAR-01 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 7230 ULTRASOUND IMAGING SYSTEM WITH TEI BIOSOUND ESAOTE, INC. 510(k) NO: K010405(TRADITIONAL) ATTN: COLLEEN HITTLE PHONE NO : 317-849-1793 8000 CASTLEWAY DR. SE DECISION MADE: 13-MAR-01 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASTRONOMER+WITH SLD BOSTON SCIENTIFIC CORP. 510(k) NO: K003362(ABBREVIATED) ATTN: ANDREA J BOUMIS PHONE NO : 408-895-3625 2710 ORCHARD PKWY. SE DECISION MADE: 01-MAR-01 SAN JOSE, CA 95134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIROYAL BILIARY PREMOUNTED STENT SYSTEM BOSTON SCIENTIFIC CORP. 510(k) NO: K003929(TRADITIONAL) ATTN: JODI L GREENIZEN PHONE NO : 508-652-5008 ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 22-MAR-01 NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527 BOSTON SCIENTIFIC CORP. 510(k) NO: K010610(SPECIAL) ATTN: LISA M QUAGLIA PHONE NO : 508-650-8267 ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 27-MAR-01 NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATLANTIS SR PLUS CORONARY IMAGING CATHETER, MODEL 35975 BOSTON SCIENTIFIC, TARGET 510(k) NO: K010707(SPECIAL) ATTN: IRENE JAWORSKI PHONE NO : 510-440-7700 47900 BAYSIDE PARKWAY SE DECISION MADE: 29-MAR-01 FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, BRANAN MEDICAL CORPORATION 510(k) NO: K004034(TRADITIONAL) ATTN: RAPHAEL WONG PHONE NO : 949-598-7166 10015 MUIRLANDS RD., SUITE E SE DECISION MADE: 08-MAR-01 IRVINE, CA 92618 510(k) STATEMENT DEVICE: TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARY BRENTWOOD MEDICAL TECHNOLOGY CORP.510(k) NO: K010505(SPECIAL) ATTN: RUOMEI ZHANG PHONE NO : 310-530-5955 3300 FUJITA STREET SE DECISION MADE: 09-MAR-01 TORRANCE, CA 90505 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXHALE DOPPLER SYSTEM BRONCUS TECHNOLOGIES, INC. 510(k) NO: K010649(TRADITIONAL) ATTN: TIMOTHY R WILLIAMS PHONE NO : 650-428-1600 1400N SHORELINE BLVD. SE DECISION MADE: 20-MAR-01 BLDG. A, SUITE 8 510(k) SUMMARY AVAILABLE FROM FDA MOUNTAIN VIEW, CA 94043 THIRD PARTY REVIEW DEVICE: OPTIFLOW CATHETER #5641190 CATHETER ONLY #5643150 CATHETER KIT # C.R. BARD, INC. 510(k) NO: K010567(SPECIAL) ATTN: PEGGY KEIFFER PHONE NO : 801-595-0700 5425 WEST AMELIA EARHART DR. SE DECISION MADE: 28-MAR-01 SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RETROGRADE CARDIOPLEGIA CANNULA, SELF-INFLATING, WITH MALLEABLE CALIFORNIA MEDICAL LABORATORIES, I510(k) NO: K002019(TRADITIONAL) ATTN: MEHMET BICAKCI PHONE NO : 949-553-9414 2681 KELVIN AVENUE SE DECISION MADE: 30-MAR-01 IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATLAS MULTI-PURPOSE DSA SYSTEM CARES BUILT, INC. 510(k) NO: K010391(TRADITIONAL) ATTN: TIMOTHY TELYMONDE PHONE NO : 732-739-8900 75 MANCHESTER AVE. SE DECISION MADE: 12-MAR-01 KEYPORT, NJ 07735 510(k) STATEMENT DEVICE: ATHENA REMOTE CONTROLLED RF SYSTEM CARES BUILT, INC. 510(k) NO: K010392(TRADITIONAL) ATTN: TIMOTHY TELYMONDE PHONE NO : 732-739-8900 75 MANCHESTER AVE. SE DECISION MADE: 12-MAR-01 KEYPORT, NJ 07735 510(k) STATEMENT DEVICE: APOLLO MOBILE "C" ARM SYSTEM CARES BUILT, INC. 510(k) NO: K010393(TRADITIONAL) ATTN: TIMOTHY TELYMONDE PHONE NO : 732-739-8900 75 MANCHESTER AVE. SE DECISION MADE: 12-MAR-01 KEYPORT, NJ 07735 510(k) STATEMENT DEVICE: DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER CELLAVISION AB 510(k) NO: K003301(TRADITIONAL) ATTN: CONSTANCE G BUNDY PHONE NO : 612-574-1976 6740 RIVERVIEW TERRACE SE DECISION MADE: 15-MAR-01 MINNEAPOLIS, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHAD THERAPEUTICS OXYMATIC MODEL 401 AND OXYMATIC MODEL 411 CHAD THERAPEUTICS, INC. 510(k) NO: K010389(SPECIAL) ATTN: KEVIN MCCULLOH PHONE NO : 818-882-0883 21622 PLUMMER ST. SE DECISION MADE: 23-MAR-01 CHATSWORTH, CA 91311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Y2000 POCKET RESCUE CHEEN HOUNG ENT. CO. LTD. 510(k) NO: K010191(TRADITIONAL) ATTN: JAY WANG PHONE NO : 886 226 892001 23 SAN DREEN ST., ALLEY 11, SE DECISION MADE: 14-MAR-01 LANE 65 510(k) STATEMENT TAIPEI (SHULIN), CHINA (TAIWAN) 23805 DEVICE: AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION CIBA VISION CORPORATION 510(k) NO: K003345(TRADITIONAL) ATTN: STEVEN DOWDLEY PHONE NO : 678-415-4214 11460 JOHNS CREEK PKWY. SE DECISION MADE: 26-MAR-01 DULUTH, GA 30097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOCUS DAILIES PROGRESSIVES CIBA VISION CORPORATION 510(k) NO: K003826(TRADITIONAL) ATTN: ALICIA M PLESNARSKI PHONE NO : 678-415-3924 11460 JOHNS CREEK PKWY. SE DECISION MADE: 08-MAR-01 DULUTH, GA 30136 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOCUS DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENSES, FOCUS D CIBA VISION CORPORATION 510(k) NO: K010636(SPECIAL) ATTN: ALICIA M PLESNARSKI PHONE NO : 678-415-3924 11460 JOHNS CREEK PKWY. SE DECISION MADE: 23-MAR-01 DULUTH, GA 30097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROSTHETIC, GELFLEX ALPHA, (POLYMACON) HYDROPHILIC CONTACT LENS CL-TINTERS 510(k) NO: K010126(TRADITIONAL) ATTN: MARTIN S KNOPF PHONE NO : 732-817-1425 10 WARRENTON LANE SE DECISION MADE: 12-MAR-01 COLTS NECK, NJ 07722 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM COHERENT STAR 510(k) NO: K003614(TRADITIONAL) ATTN: ILIRIJA ENCINAS PHONE NO : 925-249-8031 1249 QUARRY LANE SE DECISION MADE: 13-MAR-01 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA PLEASANTON, CA 94566 DEVICE: SELECTA 7000 FREQUENCY DOUBLED, Q-SWITCHED ND:YAG OPHTHALMIC LAS COHERENT, INC. 510(k) NO: K004006(TRADITIONAL) ATTN: KAREN BAKER PHONE NO : 408-764-3603 2400 CONDENSA ST. SE DECISION MADE: 26-MAR-01 SANTA CLARA, CA 95051-0901 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONCENTRIC GUIDE CATHETER, MODELS 90018, 90020 CONCENTRIC MEDICAL, INC. 510(k) NO: K003085(TRADITIONAL) ATTN: LINDA BRADLEY PHONE NO : 650-938-2100 2585 LEGHORN STREET SE DECISION MADE: 07-MAR-01 MOUTIAN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COOK PRESSURE MONITORING CATHETER COOK, INC. 510(k) NO: K002254(TRADITIONAL) ATTN: APRIL LAVENDER PHONE NO : 812-339-2235 925 SOUTH CURRY PIKE SE DECISION MADE: 16-MAR-01 P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA BLOOMINGTON, IN 47402 DEVICE: LDOB OCCLUSION BALLOON CATHETER COOK, INC. 510(k) NO: K002286(TRADITIONAL) ATTN: MARY A GOSSARD PHONE NO : 812-339-2235 925 SOUTH CURRY PIKE SE DECISION MADE: 22-MAR-01 P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA BLOOMINGTON, IN 47402 DEVICE: COOLTOUCH ND:YAG LASER SYSTEM, COOLTOUCH-II ND:YAG LASER SYSTEM, COOLTOUCH CORPORATION 510(k) NO: K003715(TRADITIONAL) ATTN: DONALD V JOHNSON PHONE NO : 916-677-1912 9085 FOOTHILLS BOULEVARD SE DECISION MADE: 01-MAR-01 ROSEVILLE, CA 95747 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRECISE NITINOL STENT TRANSHEPATIC BILLARY SYSTEM CORDIS CORP. 510(k) NO: K010445(SPECIAL) ATTN: SAM MIRZA PHONE NO : 305-824-2007 14201 N.W. 60TH AVE. SE DECISION MADE: 16-MAR-01 MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES CORDIS NEUROVASCULAR, INC. 510(k) NO: K010511(SPECIAL) ATTN: AMARILYS MACHADO PHONE NO : 305-512-6493 14000 N.W. 57TH CT. SE DECISION MADE: 01-MAR-01 MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT CORGENIX, INC. 510(k) NO: K001398(TRADITIONAL) ATTN: NANCI DEXTER PHONE NO : 303-457-4345 12061 TEJON ST. SE DECISION MADE: 30-MAR-01 WESTMINISTER, CO 80234 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CYNOSURE PHOTOGENICA NEO-V CYNOSURE, INC. 510(k) NO: K004039(TRADITIONAL) ATTN: GEORGE CHO PHONE NO : 978-256-4200 10 ELIZABETH DR. SE DECISION MADE: 29-MAR-01 CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: N PROTEIN STANDARD UY CALIBRATOR DADE BEHRING, INC. 510(k) NO: K003501(TRADITIONAL) ATTN: REBECCA S AYASH PHONE NO : 302-631-6276 GLASGOW BUSINESS COMMUNITY; SE DECISION MADE: 15-MAR-01 BLDG. 500 MAIL BOX 514 510(k) SUMMARY AVAILABLE FROM FDA P.O. BOX 6101, NEWARK, DE 19714-6101 DEVICE: N LATEX CYSTATIN C DADE BEHRING, INC. 510(k) NO: K003503(TRADITIONAL) ATTN: REBECCA S AYASH PHONE NO : 302-631-6276 GLASGOW BUSINESS COMMUNITY; SE DECISION MADE: 13-MAR-01 BLDG. 500 MAIL BOX 514 510(k) SUMMARY AVAILABLE FROM FDA P.O. BOX 6101, NEWARK, DE 19714-6101 DEVICE: DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND DADE BEHRING, INC. 510(k) NO: K010061(TRADITIONAL) ATTN: RICHARD M VAUGHT PHONE NO : 302-631-6567 GLASGOW BUSINESS COMMUNITY; SE DECISION MADE: 14-MAR-01 BLDG. 500 MAIL BOX 514 510(k) SUMMARY AVAILABLE FROM FDA P.O. BOX 6101, NEWARK, DE 19714-6101 DEVICE: DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137 DADE BEHRING, INC. 510(k) NO: K010206(TRADITIONAL) ATTN: RICHARD M VAUGHT PHONE NO : 302-631-6567 GLASCO B500 M.S. 514 SE DECISION MADE: 16-MAR-01 P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: FLEXVIEW CLINICAL MONITORING SYSTEM DATA CRITICAL CORP. 510(k) NO: K003998(SPECIAL) ATTN: TERESA DAVIDSON PHONE NO : 425-482-7047 19820 NORTH CREEK PKWY., #100 SE DECISION MADE: 07-MAR-01 BOTHELL, WA 98011 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSOIRES DATEX-OHMEDA, INC. 510(k) NO: K010463(SPECIAL) ATTN: JOEL C KENT PHONE NO : 978-640-0460 3 HIGHWOOD DR. SE DECISION MADE: 15-MAR-01 TEWKSBURY, MA 01876 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DAUM DOUBLE-SHOOT BISOPSY GUN DAUM GMBH 510(k) NO: K010037(TRADITIONAL) ATTN: CHRISTINA SMITH PHONE NO : 410-451-0639 P.O. BOX 4341 SE DECISION MADE: 22-MAR-01 CROFTON, MD 21114 510(k) STATEMENT DEVICE: NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC DENTAL POWER, INC. 510(k) NO: K004031(TRADITIONAL) ATTN: JOHN SCHOEFFEL PHONE NO : 800-222-9515 24422 DEL PRADO SE DECISION MADE: 28-MAR-01 # 11 510(k) SUMMARY AVAILABLE FROM FDA DANA POINT, CA 92629 DEVICE: PLEURX PLEURAL CATHETER AND DRAINAGE KITS DENVER BIOMEDICALS, INC. 510(k) NO: K010642(TRADITIONAL) ATTN: NANCY SAUER PHONE NO : 303-665-9423 14998 W. 6TH AVE., BLDG. E700 SE DECISION MADE: 20-MAR-01 GOLDEN, CO 80401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM DEPUY ACROMED 510(k) NO: K010320(SPECIAL) ATTN: KAREN F JURCZAK PHONE NO : 508-828-3704 325 PARAMOUNT DR. SE DECISION MADE: 01-MAR-01 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TI-REPLICA HIP STEM DEPUY ORTHOPAEDICS, INC. 510(k) NO: K003875(TRADITIONAL) ATTN: ARLENE C SAULL PHONE NO : 219-371-4904 700 ORTHOPAEDIC DR. SE DECISION MADE: 01-MAR-01 WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO TITANIUM TRI-LOCK HIPS STEM DEPUY ORTHOPAEDICS, INC. 510(k) NO: K010367(SPECIAL) ATTN: ARLENE C SAULL PHONE NO : 219-267-8143 700 ORTHOPAEDIC DR. SE DECISION MADE: 09-MAR-01 P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0988 DEVICE: DJ ORTHOPEDICS FEMORAL ANCHOR DJ ORTHOPEDICS, LLC 510(k) NO: K002829(TRADITIONAL) ATTN: JAMAL D RUSHDY PHONE NO : 760-599-1674 990 PARK CENTER DRIVE, SUITE H SE DECISION MADE: 26-MAR-01 VISTA, CA 92083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DJ ORTHOPEDICS TIBIAL ANCHOR DJ ORTHOPEDICS, LLC 510(k) NO: K003960(TRADITIONAL) ATTN: JAMAL D RUSHDY PHONE NO : 760-599-1674 990 PARK CENTER DRIVE, SUITE H SE DECISION MADE: 21-MAR-01 VISTA, CA 92083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DORNIER MEDILAS D SKINPULSE LASER SYSTEM ("SKINPULSE") DORNIER SURGICAL PRODUCTS, INC. 510(k) NO: K003993(TRADITIONAL) ATTN: WALTER PAYERL PHONE NO : 770-693-5793 10027 SOUTH 51ST ST. SE DECISION MADE: 26-MAR-01 PHOENIX, AZ 85044-6731 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM DUTCH OPHTHALMIC USA, INC. 510(k) NO: K010082(TRADITIONAL) ATTN: MARK W FURLONG PHONE NO : 603-642-8468 ONE LITTLE RIVER RD. SE DECISION MADE: 12-MAR-01 KINGSTON, NH 03848 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHEER THIN AROMAS BLUE LATEX CONDOM EAGLE TWE, INC. 510(k) NO: K004016(ABBREVIATED) ATTN: KEITH F HEINTZ PHONE NO : 864-375-1817 2090 TUCKER INDUSTRIAL ROAD SE DECISION MADE: 27-MAR-01 TUCKER, GA 30084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHEER THIN AROMAS GREEN LATEX CONDOM EAGLE TWE, INC. 510(k) NO: K004036(ABBREVIATED) ATTN: KEITH F HEINTZ PHONE NO : 678-937-0571 2090 TUCKER INDUSTRIAL ROAD SE DECISION MADE: 27-MAR-01 SUITE A-5 510(k) SUMMARY AVAILABLE FROM FDA TUCKER, GA 30084 DEVICE: SHEER THIN AROMAS YELLOW LATEX CONDOM EAGLE TWE, INC. 510(k) NO: K004051(TRADITIONAL) ATTN: KEITH F HEINTZ PHONE NO : 678-937-0571 2090 TUCKER INDUSTRIAL ROAD SE DECISION MADE: 29-MAR-01 SUITE A-5 510(k) SUMMARY AVAILABLE FROM FDA TUCKER, GA 30084 DEVICE: SHEER THIN AROMAS RED LATEX CONDOM EAGLE TWE, INC. 510(k) NO: K010028(ABBREVIATED) ATTN: KEITH HEINTZ PHONE NO : 864-375-1817 2090 TUCKER INDUSTRIAL ROAD SE DECISION MADE: 30-MAR-01 TUCKER, GA 30084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO EBI XFIX DFS RAIL SYSTEM EBI, L.P. 510(k) NO: K010437(SPECIAL) ATTN: PATRICIA FLOOD PHONE NO : 973-299-9022 100 INTERPACE PKWY. SE DECISION MADE: 13-MAR-01 PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL P ECHOCATH, INC. 510(k) NO: K010482(SPECIAL) ATTN: DAVID LYONS PHONE NO : 660-987-8400 4326 U.S. ROUTE #1 SE DECISION MADE: 20-MAR-01 MONMOUTH JUNCTION, NJ 08852 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOGARTY VALVULOTOME, MODEL 700091 EDWARDS LIFESCIENCES, LLC 510(k) NO: K001734(TRADITIONAL) ATTN: DIANE PETERSON PHONE NO : 949-250-3514 ONE EDWARDS WAY SE DECISION MADE: 26-MAR-01 IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: K.E.A.T. EMD ELECTRONIC MEDICAL DEVICES, CO510(k) NO: K002154(TRADITIONAL) ATTN: JEAN CLAUDE MARTY PHONE NO : 305-534-9594 1621 BAY ROAD, SUITE 908 SE DECISION MADE: 22-MAR-01 MIAMI BEACH, FL 33139-3260 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDIUS BIPOLAR SHEATH ENDIUS INC. 510(k) NO: K003897(TRADITIONAL) ATTN: SUSAN FINNERAN PHONE NO : 508-643-0983 23 WEST BACON ST. SE DECISION MADE: 22-MAR-01 PLAINVILLE, MA 02762 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIFIX SPINAL FIXATION SYSTEM ENDIUS INC. 510(k) NO: K010535(SPECIAL) ATTN: SUSAN FINNERAN PHONE NO : 508-643-0983 23 WEST BACON ST. SE DECISION MADE: 19-MAR-01 PLAINVILLE, MA 02762 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOCARE PERCUTANEOUS ACCESS SET ENDOCARE, INC. 510(k) NO: K010339(SPECIAL) ATTN: VINCENT CUTARELLI PHONE NO : 949-595-5424 7 STUDEBAKER SE DECISION MADE: 07-MAR-01 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LATEX EXAMINATION GLOVES-POWDERED, NONSTERILE ENZYMIC TECHNOLOGIES SDN BHD 510(k) NO: K010347(TRADITIONAL) ATTN: LEE HONG YEN PHONE NO : 062 322 336 AIR KEROH INDUSTRIAL ESTATE SE DECISION MADE: 27-MAR-01 MELAKA, MALAYSIA 75450 510(k) STATEMENT DEVICE: LATEX EXAMINATION GLOVES-POWDER FREE ENZYMIC TECHNOLOGIES SDN BHD 510(k) NO: K010356(TRADITIONAL) ATTN: LEE HONG YEN PHONE NO : 06 232 2336 AIR KEROH INDUSTRIAL ESTATE SE DECISION MADE: 27-MAR-01 MELAKA, MALAYSIA 75450 510(k) STATEMENT DEVICE: FLEXI-SITE SP02 EAR SENSOR EPIC MEDICAL EQUIPMENT SERVICES IN510(k) NO: K010718(SPECIAL) ATTN: KRISTA OAKES PHONE NO : 972-801-9854 1800 10TH ST., SUITE 300 SE DECISION MADE: 23-MAR-01 PLANO, TX 75074 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INJEX 50 SYSTEM EQUIDYNE SYSTEMS, INC. 510(k) NO: K003864(TRADITIONAL) ATTN: JIM BARLEY PHONE NO : 858-451-7001 11770 BERNARDO PLAZA CT. SE DECISION MADE: 06-MAR-01 SUITE 351 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92128 DEVICE: ESCREEN SYSTEM ESCREEN, INC. 510(k) NO: K003352(TRADITIONAL) ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794 555 THIRTEENTH ST. N.W. SE DECISION MADE: 20-MAR-01 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INDIGO LASEROPTIC TREATMENT SYSTEM ETHICON ENDO-SURGERY, INC. 510(k) NO: K003952(TRADITIONAL) ATTN: JACQUELYN A HUGHES PHONE NO : 513-337-7987 4545 CREEK RD. SE DECISION MADE: 16-MAR-01 CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INDIGO DIFFUSER-TIP FIBEROPTIC WITH TEMPERATURE SENSING OPTION, ETHICON ENDO-SURGERY, INC. 510(k) NO: K003953(TRADITIONAL) ATTN: JACKIE HUGHES PHONE NO : 513-337-7987 4545 CREEK RD. SE DECISION MADE: 16-MAR-01 CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ERO SCAN OAE TEST SYSTEM ETYMOTIC RESEARCH 510(k) NO: K010165(TRADITIONAL) ATTN: STEVE ISEBERG PHONE NO : 847-228-0006 61 MARTIN LANE SE DECISION MADE: 12-MAR-01 ELK GROVE VILLAGE, IL 60007 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTETRAK B-SERIES TOTAL KNEE SYSTEM EXACTECH, INC. 510(k) NO: K010434(SPECIAL) ATTN: LISA SIMPSON PHONE NO : 352-377-1140 2320 N.W. 66TH CT. SE DECISION MADE: 13-MAR-01 GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REAL PATIENT REAL PATIENT 128 CHANNEL EEG HEADBOX, MODEL EX-NW-1 EXCEL TECH. LTD. 510(k) NO: K010084(TRADITIONAL) ATTN: DEBBIE DAVY PHONE NO : 905 829 5300 2568 BRISTOL CIRCLE SE DECISION MADE: 16-MAR-01 OAKVILLE, ONTARIO, CANADA L6H 5S1510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP EXCEL TECH. LTD. 510(k) NO: K010085(TRADITIONAL) ATTN: SONJA MARKEZ PHONE NO : 905 829 5300 2568 BRISTOL CIRCLE SE DECISION MADE: 15-MAR-01 OAKVILLE, ONTARIO, CANADA L6H 5S1510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP EXCEL TECH. LTD. 510(k) NO: K010087(TRADITIONAL) ATTN: CAMERON MAHON PHONE NO : 905 829 5300 2568 BRISTOL CIRCLE SE DECISION MADE: 19-MAR-01 OAKVILLE, ONTARIO, CANADA L6H 5S1510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REAL PATIENT AMBULATORY EEG, MODEL EX-AMB-RP (PROPOSED) EXCEL TECH. LTD. 510(k) NO: K010088(TRADITIONAL) ATTN: CAMERON MAHON PHONE NO : 905 829 5300 2568 BRISTOL CIRCLE SE DECISION MADE: 26-MAR-01 OAKVILLE, ONTARIO, CANADA L6H 5S1510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REAL PATIENT WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS-RP ( EXCEL TECH. LTD. 510(k) NO: K010089(TRADITIONAL) ATTN: DEBBIE DAVY PHONE NO : 905 829 5300 2568 BRISTOL CIRCLE SE DECISION MADE: 26-MAR-01 OAKVILLE, ONTARIO, CANADA L6H 5S1510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4-RP (PROPOSED) EXCEL TECH. LTD. 510(k) NO: K010090(TRADITIONAL) ATTN: SONJA MARKEZ PHONE NO : 905 829 5300 2568 BRISTOL CIRCLE SE DECISION MADE: 26-MAR-01 OAKVILLE, ONTARIO, CANADA L6H 5S1510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALPHA DX SYSTEM FIRST MEDICAL INC. 510(k) NO: K010562(SPECIAL) ATTN: GREG HOLLAND PHONE NO : 949-262-0411 3722 AVE. SAUSALITO SE DECISION MADE: 13-MAR-01 IRVINE, CA 92606 510(k) STATEMENT DEVICE: MULTI-DRUG SCREEN PANELS FOREFRONT DIAGNOSTICS, INC. 510(k) NO: K003106(ABBREVIATED) ATTN: FENG-YU LEE PHONE NO : 949-595-0673 23561 RIDGE ROUTE DR., SUITE D SE DECISION MADE: 07-MAR-01 LAGUNA HILLS, CA 92653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSTACHECK DRUG SCREEN AMP 300 NG/ML CASSETTE TEST.INSTACHECK DR FOREFRONT DIAGNOSTICS, INC. 510(k) NO: K003234(ABBREVIATED) ATTN: FENG-YU LEE PHONE NO : 949-595-0673 23561 RIDGE ROUTE DR., SUITE D SE DECISION MADE: 30-MAR-01 LAGUNA HILLS, CA 92653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GALIX GBI -3S-LP GALIX BIOMEDICAL INSTRUMENTATION, 510(k) NO: K992706(TRADITIONAL) ATTN: JORDAN GAVRIELIDES PHONE NO : 305-534-5905 2555 COLLINS AVE., C-5 SE DECISION MADE: 15-MAR-01 MIAMI BEACH, FL 33140 510(k) STATEMENT DEVICE: FUNCTIONAL BRAIN MAPPING OPTION FOR MRI GE MEDICAL SYSTEM 510(k) NO: K003947(TRADITIONAL) ATTN: LARRY A KROGER PHONE NO : 262-544-3894 3200 N. GRANDVIEW BLVD. SE DECISION MADE: 13-MAR-01 WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE CT-PET SYSTEM GE MEDICAL SYSTEMS, INC. 510(k) NO: K010641(TRADITIONAL) ATTN: D DUERSTELER PHONE NO : 262-785-8219 P.O. BOX 414 SE DECISION MADE: 30-MAR-01 W-657 510(k) SUMMARY AVAILABLE FROM FDA MILWAUKEE, WI 53201 THIRD PARTY REVIEW DEVICE: SERIES 7800 MOBILE C-ARM; COMPACT 7800 MOBILE C-ARM; COMPACT 780 GE OEC MEDICAL SYSTEMS 510(k) NO: K003837(TRADITIONAL) ATTN: TED PARROT PHONE NO : 801-536-4694 384 WRIGHT BROTHERS DR. SE DECISION MADE: 12-MAR-01 SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LOGIQ 500 GENERAL ELECTRIC CO. 510(k) NO: K010329(SPECIAL) ATTN: ALLEN SCHUH PHONE NO : 414-647-4385 P.O. BOX 414 SE DECISION MADE: 01-MAR-01 MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MD 30 COMPACT GENERAL PROJECT 510(k) NO: K004014(TRADITIONAL) ATTN: CORNELIA DAMSKY PHONE NO : 203-323-7535 56 WESTCOTT ROAD SE DECISION MADE: 16-MAR-01 STAMFORD, CT 06902 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENERAL SURGICAL LAPAROSCOPES GLOBAL ENDOSCOPY, INC. 510(k) NO: K003803(TRADITIONAL) ATTN: NICK MIRCEA PHONE NO : 847-301-2733 914 W. ESTES CT. SE DECISION MADE: 07-MAR-01 SCHAUMBURG, IL 60193-4426 510(k) STATEMENT DEVICE: KTJ-20C BLOOD PRESSURE CUFF, MODEL KTJ-20C GOLDEN HORSE MEDICAL EQUIPMENT (WU510(k) NO: K010686(ABBREVIATED) ATTN: GARY C BAUMAN PHONE NO : 201-444-7204 1156 E. RIDGEWOOD AVE. SE DECISION MADE: 21-MAR-01 P.O. BOX 1211 510(k) SUMMARY AVAILABLE FROM FDA RIDGEWOOD, NJ 07451 THIRD PARTY REVIEW DEVICE: GRAMSORB SYNTHETIC ABSORBABLE SUTURE GRAMS AMERICAN SUTURE, INC. 510(k) NO: K003017(TRADITIONAL) ATTN: A. J DIMERCURIO PHONE NO : 262-375-0227 2225 DAKOTA DRIVE SE DECISION MADE: 13-MAR-01 GRAFTON, WI 53024 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GRAMS POLYESTER NONABSORBABLE SUTURE GRAMS AMERICAN SUTURE, INC. 510(k) NO: K003590(TRADITIONAL) ATTN: ANTHONY J DIMERCURIO PHONE NO : 262-375-0227 2225 DAKOTA DRIVE SE DECISION MADE: 05-MAR-01 GRAFTON, WI 53024 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY) HDC CORP. 510(k) NO: K010425(SPECIAL) ATTN: EARL SMART PHONE NO : 408-954-1909 2109 O'TOOLE AVE. SE DECISION MADE: 15-MAR-01 SAN JOSE, CA 95131 510(k) STATEMENT DEVICE: KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 6 HEINZ KURZ 510(k) NO: K010442(SPECIAL) ATTN: DAGMAR S MASER PHONE NO : 31 20 4289591 AMSTEL 320-I SE DECISION MADE: 08-MAR-01 AMSTERDAM 1017AP, NETHERLANDS 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPIFE IFE CALIBRATOR AND CONTROL KIT HELENA LABORATORIES 510(k) NO: K010617(TRADITIONAL) ATTN: PAT FRANKS PHONE NO : 409-842-3714 1530 LINDBERGH DR. SE DECISION MADE: 15-MAR-01 P.O. BOX 752 510(k) STATEMENT BEAUMONT, TX 77704 DEVICE: DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A HMI INDUSTRIES, INC. 510(k) NO: K010616(SPECIAL) ATTN: JACQUELINE PERCELL PHONE NO : 216-986-8008 13325 DARICE PARKWAY SE DECISION MADE: 28-MAR-01 STRONGSVILLE, OH 44149 510(k) STATEMENT DEVICE: PRESTIGE IQ BLOOD GLUCOSE TEST SYSTEM, MODEL 507400, 537600, 550 HOME DIAGNOSTICS, INC. 510(k) NO: K010403(SPECIAL) ATTN: KAREN DEVINCENT PHONE NO : 800-342-7226 24OO N.W. 55TH CT. SE DECISION MADE: 26-MAR-01 FORT LAUDERDALE, FL 33309 510(k) STATEMENT DEVICE: HOMMED SENTRY III PATIENT MONITOR SYSTEM HOMMED LLC 510(k) NO: K004044(TRADITIONAL) ATTN: TOMMIE J MORGAN PHONE NO : 713-880-5111 2018 NORTH DURHAM DRIVE SE DECISION MADE: 02-MAR-01 HOUSTON, TX 77008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO TRIDENT ALL POLY CUP HOWMEDICA OSTEONICS CORP. 510(k) NO: K010310(SPECIAL) ATTN: JENNIFER A DAUDELIN PHONE NO : 201-934-4354 59 ROUTE 17 SE DECISION MADE: 20-MAR-01 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMOOTH-FLO CIRCUIT HUDSON RESPIRATORY CARE, INC. 510(k) NO: K010402(SPECIAL) ATTN: CHARLES MIERKIEWICZ PHONE NO : 909-676-5611 27711 DIAZ RD. SE DECISION MADE: 14-MAR-01 P.O. BOX 9020 510(k) SUMMARY AVAILABLE FROM FDA TEMECULA, CA 92589-9020 DEVICE: FETAL ASSIST HUNTLEIGH DIAGNOSTICS LTD. 510(k) NO: K002548(TRADITIONAL) ATTN: B.J. COLLEYPRIEST PHONE NO : 011 442 920485885 35 PORTMANMOOR ROAD SE DECISION MADE: 06-MAR-01 CARDIFF 510(k) SUMMARY AVAILABLE FROM FDA SOUTH GLAMORGAN, WALES, UNITED KINGDOM CF24 5HN DEVICE: IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FO IMPRA, INC. 510(k) NO: K004011(TRADITIONAL) ATTN: LORI CHAVEZ PHONE NO : 480-894-9515 1625 WEST 3RD ST. SE DECISION MADE: 27-MAR-01 P.O. BOX 1740 510(k) SUMMARY AVAILABLE FROM FDA TEMPE, AZ 85281 DEVICE: INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM INION LTD. 510(k) NO: K010351(TRADITIONAL) ATTN: HANNA MARTTILA PHONE NO : 358 326 09610 3 SORINKATU SE DECISION MADE: 15-MAR-01 TAMPERE, FINLAND 33100 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM INION LTD. 510(k) NO: K010352(TRADITIONAL) ATTN: HANNA MARTTILA PHONE NO : 358 326 09610 3 SORINKATU SE DECISION MADE: 14-MAR-01 TAMPERE, FINLAND 33100 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO ITI DENTAL IMPLANT SYSTEM INSTITUT STRAUMANN AG 510(k) NO: K003271(TRADITIONAL) ATTN: CAROLYN BITETTI PHONE NO : 800-448-8168 RESERVOIR PLACE SE DECISION MADE: 20-MAR-01 1601 TRAPELO ROAD 510(k) SUMMARY AVAILABLE FROM FDA WALTHAM, MA 02451 DEVICE: MODIFICATION TO SYNERGY SPINAL SYSTEM INTERPORE CROSS INTL. 510(k) NO: K010515(SPECIAL) ATTN: LYNN M RODARTI PHONE NO : 949-453-3200 181 TECHNOLOGY DR. SE DECISION MADE: 22-MAR-01 IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTUITIVE SURGICAL DA VINCI ENDOSCOPIC CONTROL SYSTEM INTUITIVE SURGICAL, INC. 510(k) NO: K002489(TRADITIONAL) ATTN: DAVID CASAL PHONE NO : 650-237-7013 1340 WEST MIDDLEFIELD RD. SE DECISION MADE: 02-MAR-01 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENTURE HOME FILL II, MODEL IOH 200 INVACARE CORP. 510(k) NO: K003939(TRADITIONAL) ATTN: EDWARD A KROLL PHONE NO : 440-329-6595 ONE INVACARE WAY SE DECISION MADE: 21-MAR-01 ELYRIA, OH 44036-2125 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MCC-MIV ONE 2 ONE SOFTWARE INVACARE CORP. 510(k) NO: K010364(TRADITIONAL) ATTN: RAE ANN FARROW PHONE NO : 440-329-6356 899 CLEVELAND ST. SE DECISION MADE: 22-MAR-01 P.O. BOX 4028 510(k) SUMMARY AVAILABLE FROM FDA ELYRIA, OH 44036 DEVICE: D.SIGN 30 IVOCLAR NORTH AMERICA, INC. 510(k) NO: K010381(TRADITIONAL) ATTN: ANDY GULATI PHONE NO : 716-691-0010 175 PINEVIEW DR. SE DECISION MADE: 06-MAR-01 AMHERST, NY 14228 510(k) STATEMENT DEVICE: JAS MAGNESIUM REAGENT JAS DIAGNOSTIC, INC. 510(k) NO: K003835(TRADITIONAL) ATTN: DAVID JOHNSTON PHONE NO : 305-418-2320 7220 NW 58TH ST. SE DECISION MADE: 23-MAR-01 MIAMI, FL 33166 510(k) STATEMENT DEVICE: HERACERAM 75 JELENKO CO. 510(k) NO: K010416(TRADITIONAL) ATTN: RAPHAEL JUDKINS PHONE NO : 914-273-8600 99 BUSINESS PARK DRIVE SE DECISION MADE: 08-MAR-01 ARMONK, NY 10504 510(k) STATEMENT DEVICE: WILLI GELLER CREAPEARL JENSEN INDUSTRIES, INC. 510(k) NO: K010160(TRADITIONAL) ATTN: JOHN SLANSKI PHONE NO : 203-239-2090 50 STILLMAN RD. SE DECISION MADE: 27-MAR-01 NORTH HAVEN, CT 06473 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: R & D DESIGNATION AP-035 JENSEN INDUSTRIES, INC. 510(k) NO: K010414(ABBREVIATED) ATTN: JOHN SLANSKI PHONE NO : 203-239-2090 50 STILLMAN RD. SE DECISION MADE: 27-MAR-01 NORTH HAVEN, CT 06473 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: R & D DESIGNATION AP-047 JENSEN INDUSTRIES, INC. 510(k) NO: K010611(ABBREVIATED) ATTN: JOHN SLANSKI PHONE NO : 203-239-2090 50 STILLMAN RD. SE DECISION MADE: 27-MAR-01 NORTH HAVEN, CT 06473 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WRISTWATCH BPM BLOOD PRESSURE MONITOR, MODEL KP-6120 K-JUMP HEALTH CO., LTD. 510(k) NO: K002665(TRADITIONAL) ATTN: JOHATHAN S KAHAN PHONE NO : 202-637-5794 555 THIRTEEN STREET, N.W. SE DECISION MADE: 19-MAR-01 WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KSEA SCB-RUI SCO KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K003113(TRADITIONAL) ATTN: KEVIN KENNAN PHONE NO : 310-410-2769 600 CORPORATE POINTE SE DECISION MADE: 27-MAR-01 CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SLEEVED FILTER KING SYSTEMS CORP. 510(k) NO: K010040(TRADITIONAL) ATTN: CHARLES A BURT PHONE NO : 800-642-5464 15011 HERRIMAN BLVD. SE DECISION MADE: 09-MAR-01 P.O. BOX 1138 510(k) STATEMENT NOBLESVILLE, IN 46060 DEVICE: LASEREX INTEGRE, MODEL LP2532 LASEREX SYSTEMS 510(k) NO: K003955(TRADITIONAL) ATTN: KEITH DEGENHARDT PHONE NO : 061 882 236644 258 HALIFAX ST. SE DECISION MADE: 15-MAR-01 ADELAIDE, S.A., AUSTRALIA 5000 510(k) STATEMENT DEVICE: LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG LASERSCOPE 510(k) NO: K003765(TRADITIONAL) ATTN: PAUL H HARDMAN PHONE NO : 800-243-9384 3052 ORCHARD DR. SE DECISION MADE: 06-MAR-01 SAN JOSE, CA 95134-2011 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFECARE COMPACT TENS DEVICE LIFECARE LTD. 510(k) NO: K003369(TRADITIONAL) ATTN: AHAVA STEIN PHONE NO : 972 976 70002 BEIT HAPA'AMON (BOX 124) SE DECISION MADE: 08-MAR-01 20 HATA'AS ST., 510(k) STATEMENT KFAR SABA, ISRAEL 44425 DEVICE: SHAVER ABLATOR LINVATEC CORP. 510(k) NO: K002088(TRADITIONAL) ATTN: LAURA D SENEFF PHONE NO : 727-399-5234 11311 CONCEPT BLVD. SE DECISION MADE: 06-MAR-01 LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUPER REVO SUTURE ANCHOR LINVATEC CORP. 510(k) NO: K003984(TRADITIONAL) ATTN: LAURA D SENEFF PHONE NO : 727-399-5234 11311 CONCEPT BLVD. SE DECISION MADE: 19-MAR-01 LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING MAERSK MEDICAL, LTD. 510(k) NO: K004028(TRADITIONAL) ATTN: LARA N SIMMONS PHONE NO : 847-949-2639 ONE MEDLINE PLACE SE DECISION MADE: 27-MAR-01 MUNDELEIN, IL 60060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HINT AUDIOMETER, OR HINT MAICO-DIAGNOSTICS 510(k) NO: K003913(TRADITIONAL) ATTN: DANIEL EGGAN PHONE NO : 952-941-4200 9675 WEST 76TH ST. SE DECISION MADE: 16-MAR-01 EDEN PRAIRIE, MN 55344 510(k) STATEMENT DEVICE: MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES MASIMO CORP. 510(k) NO: K010419(SPECIAL) ATTN: JAMES J CRONIN PHONE NO : 949-250-9688 2852 KELVIN AVE. SE DECISION MADE: 06-MAR-01 IRVINE, CA 92614-5826 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PANASONIC TELE-HOMECARE SYSTEM MATSUSHITA ELECTRIC INDUSTRIAL CO.510(k) NO: K004050(TRADITIONAL) ATTN: DAVID L WEST PHONE NO : 1801 ROCKVILLE PIKE SE DECISION MADE: 15-MAR-01 ROCKVILLE, MD 20852 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDEVIEW SYSTEM MEDEVIEW.COM 510(k) NO: K002789(TRADITIONAL) ATTN: JEFFREY O BOILY PHONE NO : 781-693-5000 1400 MAIN STREET SE DECISION MADE: 21-MAR-01 SUITE 120 510(k) STATEMENT WALTHAN, MA 02451 DEVICE: BLASTASSIST SYSTEM MEDI-CULT A/S 510(k) NO: K003156(TRADITIONAL) ATTN: RONALD G LEONARDI PHONE NO : 858-586-0751 9915 CAM. CHIRIMOLLA SE DECISION MADE: 22-MAR-01 SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNVITRO FLUSH MEDI-CULT A/S 510(k) NO: K003163(TRADITIONAL) ATTN: RONALD G LEONARDI PHONE NO : 858-586-0751 P.O. BOX 262069 SE DECISION MADE: 22-MAR-01 SAN DIEGO, CA 92196-2069 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUPRASPERM SYSTEM MEDI-CULT A/S 510(k) NO: K003404(TRADITIONAL) ATTN: RONALD G LEONARDI PHONE NO : 858-586-0751 9915 CAM. CHIRIMOLLA SE DECISION MADE: 22-MAR-01 SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDICA HP 300 HEMOFILTRATION PUMP, MODEL 300 MEDICA S.R.L. 510(k) NO: K000724(TRADITIONAL) ATTN: JAMES DELANEY PHONE NO : 978-371-0066 100 MAIN STREET SE DECISION MADE: 22-MAR-01 SUITE 120 510(k) SUMMARY AVAILABLE FROM FDA CONCORD, MA 01742 DEVICE: MEDICAL DEPOT NEBULIZER, MODEL POWER NEB 2 MEDICAL DEPOT, INC. 510(k) NO: K003344(TRADITIONAL) ATTN: ART WARD PHONE NO : 813-645-2855 962 ALLEGRO LANE SE DECISION MADE: 15-MAR-01 APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CENTURA PHOTOTHERAPY SPOTLIGHT MEDICAL ILLUMINATION INTERNATIONAL510(k) NO: K010495(TRADITIONAL) ATTN: DAVID GLOVER PHONE NO : 818-838-3025 547 LIBRARY ST. SE DECISION MADE: 09-MAR-01 SAN FERNANDO, CA 91340 510(k) STATEMENT DEVICE: ULTRASONIC NEBULIZER, MODEL NE-520 MEDISANA USA, INC. 510(k) NO: K002153(TRADITIONAL) ATTN: GUENTER GINSBERG PHONE NO : 941-948-2001 11820 RED HIBISCUS DRIVE SE DECISION MADE: 13-MAR-01 BONITA SPRINGS, FL 34135 510(k) STATEMENT DEVICE: ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200 MEDIVANCE, INC. 510(k) NO: K010338(SPECIAL) ATTN: LYNNE ARONSON PHONE NO : 303-926-1917 500 S. ARTHUR AVENUE, STE 100 SE DECISION MADE: 07-MAR-01 LOUISVILLE, CO 80027 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDTRADE PRODUCTS SILICON SCAR MANAGEMENT PAD MEDTECH PRODUCTS LTD. 510(k) NO: K003979(TRADITIONAL) ATTN: JONATHAN D RANFIELD PHONE NO : 441 270 500019 ELECTRA HOUSE, CREWE BUSINESS SE DECISION MADE: 19-MAR-01 PARK 510(k) STATEMENT CREWE, CHESHIRE, UNITED KINGDOM CW1 6GL DEVICE: LOCALISA CARDIAC NAVIGATION SYSTEM MEDTRONIC SURGICAL NAVIGATION TECH510(k) NO: K002869(TRADITIONAL) ATTN: THOMAS PARKER PHONE NO : 763-514-1551 3850 VICTORIA STREET NORTH SE DECISION MADE: 27-MAR-01 SHOREVIEW, MN 55126 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MENTOR SELF-CATH PLUS MENTOR CORP. 510(k) NO: K003784(TRADITIONAL) ATTN: DONNA A CRAWFORD PHONE NO : 805-879-6304 201 MENTOR DRIVE SE DECISION MADE: 05-MAR-01 SANTA BARBARA, CA 93111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MENTOR SELF-CATH CLOSED SYSTEM MENTOR CORP. 510(k) NO: K003873(TRADITIONAL) ATTN: DONNA A CRAWFORD PHONE NO : 805-879-6304 201 MENTOR DRIVE SE DECISION MADE: 29-MAR-01 SANTA BARBARA, CA 93111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCUSONIC, MODEL AS-260 METRON MEDICAL AUSTRALIA P/L 510(k) NO: K010609(SPECIAL) ATTN: ROB HOPKINS PHONE NO : 613 977 51234 57 ASTER AVE. SE DECISION MADE: 16-MAR-01 CARRUM DOWNS, VICTORIA, AUSTRALIA 510(k) STATEMENT DEVICE: ELISA TEST, SEROLOGY MICRO DETECT, INC. 510(k) NO: K003794(TRADITIONAL) ATTN: MEDHI ALEM PHONE NO : 714-832-8234 2852 WALNUT AVE. SE DECISION MADE: 30-MAR-01 TUSTIN, CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SILVERSPEED HYDROPHILIC GUIDEWIRE, MODELS 103-0601-300 AND 103-0 MICRO THERAPEUTICS, INC. 510(k) NO: K010497(SPECIAL) ATTN: EBEN GORDON PHONE NO : 949-837-3700 2 GOODYEAR SE DECISION MADE: 22-MAR-01 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEOLYNX SCREENING APPLICATION MANAGER MICROMASS INC. 510(k) NO: K003584(TRADITIONAL) ATTN: DANIEL J DILLON PHONE NO : 508-482-2121 34 MAPLE STREET SE DECISION MADE: 19-MAR-01 MILFORD, MA 01757 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARRIAZO BARRAQUER SINGLE USE MICROKERATOME MORIA, INC. 510(k) NO: K003594(TRADITIONAL) ATTN: DAVID CONRAD PHONE NO : 331 467 44674 15 RUE GEORGES BESSE SE DECISION MADE: 09-MAR-01 ANTONY, FRANCE 92160 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IFIS-SA INTEGRATED FUCTIONAL IMAGING SYSTEM MRI DEVICES CORP. 510(k) NO: K003899(TRADITIONAL) ATTN: WILLIAM DINEHART PHONE NO : 262-524-1402 1515 PARAMOUNT DRIVE SE DECISION MADE: 15-MAR-01 WAUKESHA, WI 53186 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTI CARE THERAPEUTIC VIBRATOR MULTICEPT A/S 510(k) NO: K010096(SPECIAL) ATTN: KLAUS VAMMEN PHONE NO : 454 576 0515 LYNGSOE ALLE 3,1 SE DECISION MADE: 05-MAR-01 HOERSHOLM, DENMARK 2970 510(k) STATEMENT DEVICE: MICROWAVAE DELIVERY SYSTEM #MW2000 MW MEDICAL, INC. 510(k) NO: K010589(SPECIAL) ATTN: GREG HOLLAND PHONE NO : 949-262-0411 3722 AVE. SAUSALITO SE DECISION MADE: 19-MAR-01 IRVINE, CA 92606 510(k) STATEMENT DEVICE: MN-4 COARSE MANIPULATOR NARISHIGE CO., LTD. 510(k) NO: K010298(TRADITIONAL) ATTN: MITSUKO YONEYAMA PHONE NO : 813 330 88383 27-9 MINAMIKARASUYAMA 4-CHOME SE DECISION MADE: 16-MAR-01 SETAGAYA-KU, TOKYO, JAPAN 157-0062510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERILE SUBDERMAL NEEDLE ELECTRODES NICOLET BIOMEDICAL, INC. 510(k) NO: K010019(ABBREVIATED) ATTN: GARY SYRING PHONE NO : 608-877-2635 800 LEVANGER LANE SE DECISION MADE: 19-MAR-01 STOUGHTON, WI 53589 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NICOLET VERSALAB NICOLET VASCULAR INC. 510(k) NO: K010521(SPECIAL) ATTN: DAVID W WAGNER PHONE NO : 303-431-9400 6355 JOYCE DR. SE DECISION MADE: 09-MAR-01 GOLDEN, CO 80403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPD-SCAN, MODELS ARK-10000 AND ARK-9000 NIDEK CO., LTD. 510(k) NO: K003299(TRADITIONAL) ATTN: CAROL PATTERSON PHONE NO : 949-462-0900 21911 ERIE LANE SE DECISION MADE: 09-MAR-01 LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INNOVO NOVO NORDISK A/S 510(k) NO: K010359(TRADITIONAL) ATTN: ROBERT FISCHER PHONE NO : 609-987-5800 100 COLLEGE ROAD WEST SE DECISION MADE: 14-MAR-01 PRINCETON, NJ 08540 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE CB-PE MICROKERATOME BLADES OASIS MEDICAL, INC. 510(k) NO: K003820(TRADITIONAL) ATTN: YVONNE FERNANDEZ PHONE NO : 626-914-2891 514 S. VERMONT AVE. SE DECISION MADE: 08-MAR-01 GLENDORA, CA 91741 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OHMEDA MEDICAL GIRAFFE INCUBATOR OHMEDA MEDICAL 510(k) NO: K010222(TRADITIONAL) ATTN: ALBERTO F PROFUMO PHONE NO : 410-888-5104 8880 GORMAN RD. SE DECISION MADE: 21-MAR-01 LAUREL, MD 20723 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER COI OLSON MEDICAL SALES, INC. 510(k) NO: K000977(TRADITIONAL) ATTN: GARY A COURTNEY PHONE NO : 800-283-7866 125 BLUE BALL ROAD SE DECISION MADE: 23-MAR-01 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER OLYMPUS OPTICAL CO., LTD. 510(k) NO: K010591(TRADITIONAL) ATTN: TSUYOSHI YANAI PHONE NO : 814 264 22891 2951 ISHIKAWA-CHO SE DECISION MADE: 15-MAR-01 HACHIOJI-SHI 510(k) SUMMARY AVAILABLE FROM FDA TOKYO, JAPAN 192-8507 THIRD PARTY REVIEW DEVICE: OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STI OMNISONICS MEDICAL TECHNOLOGIES 510(k) NO: K003824(TRADITIONAL) ATTN: DOUG CHARLAND PHONE NO : 978-657-9980 66 CONCORD STREET, SUITE A SE DECISION MADE: 08-MAR-01 WILMINGTON, MA 01887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRAVUE/P 2000T, ULTRAVUE/C 2000T (HIOXIFILCON B) SOFT (MULTIFO OPTI-CENTRE LABORATORIES 510(k) NO: K010256(TRADITIONAL) ATTN: MARTIN DALSING PHONE NO : 970-243-5490 623 GLACIER DRIVE SE DECISION MADE: 26-MAR-01 GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: F1 DIODE LASER SYSTEM OPUS MEDICAL, INC. 510(k) NO: K004021(TRADITIONAL) ATTN: CONNIE WHITE-HOY PHONE NO : 505-323-2403 9630 TOWNER NE SE DECISION MADE: 27-MAR-01 ALBUQUERQUE,, NM 87112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VULCAN ABLATOR ELECTROSURGICAL PROBES, VULCAN LIGAMENT CHISEL EL ORATEC INTERVENTIONS, INC. 510(k) NO: K003893(TRADITIONAL) ATTN: LINDA GUTHRIE PHONE NO : 650-687-2629 3700 HAVEN CT. SE DECISION MADE: 01-MAR-01 MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: O2/CO2 NASAL FILTERLINE ORIDION MEDICAL 1987 LTD. 510(k) NO: K010024(TRADITIONAL) ATTN: SANFORD BROWN PHONE NO : 972 258 99115 7 HAMARPE ST. P.O. BOX 45025 SE DECISION MADE: 14-MAR-01 HAR HOTZVIM INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA JERUSALEM, ISRAEL 91450 DEVICE: ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION ORTHOTEC, L.L.C. 510(k) NO: K001535(TRADITIONAL) ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640 200 GREGORY LANE SE DECISION MADE: 20-MAR-01 SUITE C-100 510(k) SUMMARY AVAILABLE FROM FDA PLEASANT HILL, CA 94523-3389 DEVICE: SONICAID FM820, SONICAID FM830 OXFORD INSTRUMENTS 510(k) NO: K002150(TRADITIONAL) ATTN: STEVE VALE PHONE NO : 148 377 0331 MANOR WAY SE DECISION MADE: 09-MAR-01 OLD WOKING, SURREY, UNITED KINGDOM510(k) STATEMENT DEVICE: PALOMAR SPALIGHT PULSED LIGHT SYSTEM PALOMAR MEDICAL TECHNOLOGIES, INC.510(k) NO: K003886(TRADITIONAL) ATTN: MARCY MOORE PHONE NO : 919-363-2432 131 KELEKENT LANE SE DECISION MADE: 01-MAR-01 CARY, NC 27511 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRONEB ULTRA MODEL NUMBER 85B0100 PARI HOLDING CO. 510(k) NO: K002862(TRADITIONAL) ATTN: DEBRA A PEKAR PHONE NO : 804-639-7235 13800 HULL ST. RD. SE DECISION MADE: 13-MAR-01 MIDLOTHIAN, VA 23112 510(k) STATEMENT DEVICE: PECTOFIX STERNAL REPAIR WIRE PECTOFIX, INC. 510(k) NO: K003951(TRADITIONAL) ATTN: ERIC BANNON PHONE NO : 908-756-9643 2509 PARK AVENUE SE DECISION MADE: 21-MAR-01 SOUTH PLAINFIELD, NJ 07080 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUPERCROSS CATHETER PERCLOSE, INC. 510(k) NO: K001856(TRADITIONAL) ATTN: DAUN S PUTNAM PHONE NO : 650-474-3135 400 SAGINAW SE DECISION MADE: 07-MAR-01 REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AT HOME DRUG TEST, MODEL 9063 T PHAMATECH 510(k) NO: K010645(SPECIAL) ATTN: CARL A MONGIOVI PHONE NO : 858-635-5840 9530 PADGETT STREET #101 SE DECISION MADE: 30-MAR-01 SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AT HOME DRUG TEST, MODEL 9083 T PHAMATECH 510(k) NO: K010646(SPECIAL) ATTN: CARL A MONGIOVI PHONE NO : 858-635-5840 9530 PADGETT STREET #101 SE DECISION MADE: 30-MAR-01 SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AT HOME DRUG TEST, MODEL 9073 T PHAMATECH 510(k) NO: K010650(SPECIAL) ATTN: CARL A MONGIOVI PHONE NO : 858-635-5840 9530 PADGETT STREET #101 SE DECISION MADE: 30-MAR-01 SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AT HOME DRUG TEST, MODEL 9133 T PHAMATECH 510(k) NO: K010651(SPECIAL) ATTN: CARL A MONGIOVI PHONE NO : 858-635-5840 9530 PADGETT STREET #101 SE DECISION MADE: 30-MAR-01 SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHILIPS BV PULSERA/ENDURA PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K010435(TRADITIONAL) ATTN: MARCIA JONES PHONE NO : 203-926-7650 710 BRIDGEPORT AVE. SE DECISION MADE: 12-MAR-01 SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XTRAC EXCIMER LASER SYSTEM, MODEL AL7000 PHOTO MEDEX, INC. 510(k) NO: K003705(TRADITIONAL) ATTN: AL MEMMOLO PHONE NO : 760-602-3300 2431 IMPALA DR. SE DECISION MADE: 01-MAR-01 CARLSBAD, CA 92008-7227 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 240 PARUS ULTRASOUND IMAGING SYSTEMS, MODEL 240 PARUS PIE MEDICAL 510(k) NO: K003725(TRADITIONAL) ATTN: COLLEEN J HITTLE PHONE NO : 317-849-1916 SE DECISION MADE: 01-MAR-01 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLANMED SOPHIE, PLANMED SOPHIE CLASSIC PLANMED OY 510(k) NO: K010116(TRADITIONAL) ATTN: BOB PIENKOWSKI PHONE NO : 630-953-2368 1250 GREENBRIAR, SUITE A SE DECISION MADE: 15-MAR-01 ADDISON, IL 60101 510(k) STATEMENT DEVICE: PM 1800 CONSERVING DEVICE PRECISION MEDICAL, INC. 510(k) NO: K001412(ABBREVIATED) ATTN: CONLEY WALLACE PHONE NO : 610-262-6090 300 HELD DR. SE DECISION MADE: 20-MAR-01 NORTHAMPTON, PA 18067 510(k) STATEMENT DEVICE: PVS 1300 NEURO GUIDE WIRE PRECISION VASCULAR SYSTEMS, INC. 510(k) NO: K002907(TRADITIONAL) ATTN: JOHN R RAGAZZO PHONE NO : 801-585-7069 360 WAKARA WAY SE DECISION MADE: 08-MAR-01 SALT LAKE CITY, UT 84108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LASER 3 SPSC300 PRIDE MOBILITY PRODUCTS CORP. 510(k) NO: K003058(TRADITIONAL) ATTN: GENE R KULON PHONE NO : 570-655-5574 182 SUSQUEHANNA AVE. SE DECISION MADE: 08-MAR-01 EXETER, PA 18643 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LASER 4SPSC340 PRIDE MOBILITY PRODUCTS CORP. 510(k) NO: K003059(TRADITIONAL) ATTN: GENE R K ULON PHONE NO : 570-655-5574 182 SUSQUEHANNA AVE. SE DECISION MADE: 01-MAR-01 EXETER, PA 18643 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO LAP TOP VENTILATOR (LTV) PULMONETIC SYSTEMS, INC. 510(k) NO: K010608(SPECIAL) ATTN: DARRYL SHELBY PHONE NO : 909-783-2280 930 SOUTH MT. VERNON AVE., SE DECISION MADE: 20-MAR-01 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA COLTON, CA 92324-3928 DEVICE: SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL QUANTIMETRIX CORP. 510(k) NO: K010598(TRADITIONAL) ATTN: EVA LASZLO PHONE NO : 310-536-0006 2005 MANHATTAN BEACH BLVD. SE DECISION MADE: 23-MAR-01 REDONDO BEACH, CA 90278-1205 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SWABSITE SWABBABLE VALVE, MODEL 245000 QUEST MEDICAL, INC. 510(k) NO: K002689(TRADITIONAL) ATTN: DOUG BRYAN PHONE NO : 972-390-9800 ONE ALLENTOWN PKWY. SE DECISION MADE: 06-MAR-01 ALLEN, TX 75002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CBC-SF R & D SYSTEMS, INC. 510(k) NO: K010409(TRADITIONAL) ATTN: KENNETH T EDDS PHONE NO : 612-379-2956 614 MCKINLEY PL., N.E. SE DECISION MADE: 16-MAR-01 MINNEAPOLIS, MN 55413 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) RADIONICS, A DIVISION OF TYCO HEAL510(k) NO: K010548(SPECIAL) ATTN: KEVIN J O'CONNELL PHONE NO : 800-466-6814 22 TERRY AVE. SE DECISION MADE: 12-MAR-01 BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RANDOX GLUCOSE (GOD/PAP) RANDOX LABORATORIES LTD. 510(k) NO: K003346(TRADITIONAL) ATTN: P. ARMSTRONG PHONE NO : 44 289 4422413 ARDMORE, DIAMOND ROAD SE DECISION MADE: 15-MAR-01 CRUMLIN, CO. 510(k) STATEMENT ANTRIM, UNITED KINGDOM BT29 4QY DEVICE: SAFARI RANGER ALL SEASON CORP. 510(k) NO: K010606(SPECIAL) ATTN: RON STEWART PHONE NO : 712-475-2811 P.O. BOX 132 SE DECISION MADE: 16-MAR-01 GEORGE, IA 51237 510(k) STATEMENT DEVICE: PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR RAVEN BIOLOGICAL LABORATORIES, INC510(k) NO: K994381(TRADITIONAL) ATTN: WENDY ROYALTY PHONE NO : 402-593-0781 8607 PARK DR. SE DECISION MADE: 30-MAR-01 OMAHA, NE 68127 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARSET NEEDLELESS PRIMARY SET FOR BLUNT CANNULA, A10003E, PARSET RD MEDICAL MFG., INC. 510(k) NO: K010538(ABBREVIATED) ATTN: CARLOS A RODRIGUEZ-GARCIA PHONE NO : 787-742-3800 CALLE ESCUDERO FINAL, BO. SE DECISION MADE: 30-MAR-01 FULLADOSA 510(k) SUMMARY AVAILABLE FROM FDA CUELBRA, PR 00775 DEVICE: REDTECH GIPC 2000 RED-TECH, INC. 510(k) NO: K004040(TRADITIONAL) ATTN: GARY MOCNIK PHONE NO : 949-363-2953 27881 LA PAZ ROAD SE DECISION MADE: 29-MAR-01 LAGUNA NIGUEL, CA 510(k) STATEMENT DEVICE: PROFOX SOFTWARE, MODEL 920M-41 RESPIRONICS GEORGIA, INC. 510(k) NO: K001708(TRADITIONAL) ATTN: GERRY RICHARDSON PHONE NO : 770-429-2853 1255 KENNESTONE CIRCLE SE DECISION MADE: 01-MAR-01 MARIETTA, GA 30066 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZE RESPIRONICS, INC. 510(k) NO: K010052(ABBREVIATED) ATTN: DAVID J VANELLA PHONE NO : 724-733-5866 125 CHASTAIN MEADOW COURT SE DECISION MADE: 19-MAR-01 KENNESAW, GA 30144-3724 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REMSTAR PLUS CPAP SYSTEM RESPIRONICS, INC. 510(k) NO: K010263(TRADITIONAL) ATTN: DAVID J VANELLA PHONE NO : 724-733-5866 1001 MURRY RIDGE LANE SE DECISION MADE: 29-MAR-01 MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND I RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K000180(TRADITIONAL) ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113 353 CORPORATE WOODS PKWY. SE DECISION MADE: 02-MAR-01 VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLYCARBOXYLATE (PCA) CEMENT RITE-DENT MANUFACTURING CORPORATIO510(k) NO: K010240(TRADITIONAL) ATTN: CESAR E VELIZ PHONE NO : 305-693-8626 1056 EAST 33RD ST. SE DECISION MADE: 27-MAR-01 HIALEAH, FL 33013-3526 510(k) STATEMENT DEVICE: ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA; ROCHE DIA ROCHE DIAGNOSTICS CORP. 510(k) NO: K002706(TRADITIONAL) ATTN: KAY A TAYLOR PHONE NO : 317-576-3544 9115 HAGUE RD. SE DECISION MADE: 16-MAR-01 P.O. BOX 50457 510(k) SUMMARY AVAILABLE FROM FDA INDIANAPOLIS, IN 46250-0457 DEVICE: ELECSYS TESTOSTERONE CALSET II ROCHE DIAGNOSTICS CORP. 510(k) NO: K003411(ABBREVIATED) ATTN: KAY A TAYLOR PHONE NO : 317-576-3544 9115 HAGUE ROAD SE DECISION MADE: 01-MAR-01 P.O. BOX 50457 510(k) SUMMARY AVAILABLE FROM FDA INDIANAPOLIS, IN 46250-0457 DEVICE: ACCU-CHEK INFORM METER ROCHE DIAGNOSTICS CORP. 510(k) NO: K003846(TRADITIONAL) ATTN: MIKE FLIS PHONE NO : 800-428-5074 9115 HAGUE RD. SE DECISION MADE: 19-MAR-01 P.O. BOX 50457 510(k) SUMMARY AVAILABLE FROM FDA INDIANAPOLIS, IN 46250-0457 DEVICE: ACCU-CHEK COMFORT CURVE TEST STRIP ROCHE DIAGNOSTICS CORP. 510(k) NO: K010362(SPECIAL) ATTN: MIKE FLIS PHONE NO : 800-428-5074 9115 HAGUE RD. SE DECISION MADE: 07-MAR-01 P.O. BOX 50457 510(k) SUMMARY AVAILABLE FROM FDA INDIANAPOLIS, IN 46250-0457 DEVICE: ELECSYSCA 15-3 II ASSAY ROCHE DIAGNOSTICS CORP. 510(k) NO: K010588(SPECIAL) ATTN: KAY A TAYLOR PHONE NO : 317-576-3544 9115 HAGUE ROAD SE DECISION MADE: 28-MAR-01 P.O. BOX 50457 510(k) SUMMARY AVAILABLE FROM FDA INDIANAPOLIS, IN 46250-0457 DEVICE: WRISTWATCH BLOOD PRESSURE MONITOR A46 ROSSMAX INTERNATIONL LTD. 510(k) NO: K010498(SPECIAL) ATTN: MICHAEL YEH PHONE NO : 011 886 226597888 12F, NO. 189, KANG CHIEN RD. SE DECISION MADE: 20-MAR-01 TAIPEI, CHINA (TAIWAN) 114 510(k) STATEMENT DEVICE: SAN UP S.A. NEBULIZER COMPRESSOR, WITH DISPOSABLE NEBULIZER, MOD SAN UP S.A. 510(k) NO: K002468(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511 55 NOTHERN BLVD., SUITE 200 SE DECISION MADE: 02-MAR-01 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SARSTEDT NEEDLE PROTECTOR SARSTEDT, INC. 510(k) NO: K003382(TRADITIONAL) ATTN: PETER RUMSWINKEL PHONE NO : 828-465-4000 1025 ST. JAMES CHURCH ROAD SE DECISION MADE: 30-MAR-01 PO BOX 468 510(k) STATEMENT NEWTON, NC 28658 DEVICE: SCIMEDX PHASE II PR3 IGG ANTIBODY EIA SCIMEDX CORP. 510(k) NO: K010287(TRADITIONAL) ATTN: GARY LEHNUS PHONE NO : 973-625-8822 400 FORD RD. SE DECISION MADE: 16-MAR-01 DENVILLE, NJ 07834 510(k) STATEMENT DEVICE: SCIMEDX PHASE II MPO IGG ANTIBODY EIA SCIMEDX CORP. 510(k) NO: K010289(TRADITIONAL) ATTN: GARY LEHNUS PHONE NO : 973-625-8822 400 FORD RD. SE DECISION MADE: 07-MAR-01 DENVILLE, NJ 07834 510(k) STATEMENT DEVICE: CONTOUR PROFILE LASER SCITON, INC. 510(k) NO: K010285(SPECIAL) ATTN: PETER N ALLEN PHONE NO : 650-493-9155 845 COMMERCIAL AVE. SE DECISION MADE: 01-MAR-01 PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I SENSIDYNE, INC. 510(k) NO: K010382(SPECIAL) ATTN: GEORGE MASON PHONE NO : 727-530-3602 16333 BAY VISTA DR. SE DECISION MADE: 01-MAR-01 CLEARWATER, FL 33760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA, GREEN (TE SHEN WEI (USA), INC. 510(k) NO: K010097(TRADITIONAL) ATTN: BELLE L CHOU PHONE NO : 510-429-8692 2845 WHIPPLE RD. SE DECISION MADE: 30-MAR-01 UNION CITY, CA 94587 510(k) STATEMENT DEVICE: AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM SIEMENS MEDICAL CORP. 510(k) NO: K010721(TRADITIONAL) ATTN: PRAVEEN NADKARNI PHONE NO : 732-321-4950 186 WOOD AVE. SOUTH SE DECISION MADE: 30-MAR-01 ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFINITY ETCO2 + RESPIRATORY MECHANICS POD SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K003550(TRADITIONAL) ATTN: PENELOPE H GREEN PHONE NO : 978-907-7500 16 ELECTRONICS AVENUE SE DECISION MADE: 07-MAR-01 DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIEMENS MEDICAL INFORMATION BUS (MIB II) PROTOCOL CONVERTER SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K010640(SPECIAL) ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500 16 ELECTRONICS AVE. SE DECISION MADE: 20-MAR-01 DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A SIGMA DIAGNOSTICS, INC. 510(k) NO: K003267(TRADITIONAL) ATTN: WILLIAM R GILBERT II PHONE NO : 314-286-6693 545 SOUTH EWING AVE. SE DECISION MADE: 15-MAR-01 ST. LOUIS, MO 63103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCUCLOT CONTROL I, MODEL A4089 SIGMA DIAGNOSTICS, INC. 510(k) NO: K003328(TRADITIONAL) ATTN: WILLIAM R GILBERT PHONE NO : 314-286-6693 545 SOUTH EWING AVE. SE DECISION MADE: 01-MAR-01 ST. LOUIS, MO 63103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217 SIGMA DIAGNOSTICS, INC. 510(k) NO: K003329(TRADITIONAL) ATTN: WILLIAM R GILBERT PHONE NO : 314-286-6693 545 SOUTH EWING AVE. SE DECISION MADE: 01-MAR-01 ST. LOUIS, MO 63103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THROMBOMAX-HS WITH CALCIUM, MODEL T6540 SIGMA DIAGNOSTICS, INC. 510(k) NO: K010158(TRADITIONAL) ATTN: WILLIAM R GILBERT II PHONE NO : 314-286-6693 545 SOUTH EWING AVE. SE DECISION MADE: 22-MAR-01 ST. LOUIS, MO 63103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936 SIGMA DIAGNOSTICS, INC. 510(k) NO: K010652(TRADITIONAL) ATTN: WILLIAM R GILBERT II PHONE NO : 314-286-6693 545 SOUTH EWING AVE. SE DECISION MADE: 30-MAR-01 ST. LOUIS, MO 63103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED SIMS DELTEC, INC. 510(k) NO: K010426(TRADITIONAL) ATTN: LISA J STONE PHONE NO : 651-633-2556 1265 GREY FOX RD. SE DECISION MADE: 08-MAR-01 ST. PAUL, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW SUTURE HAPLA INTERFERENCE SCREW SMITH & NEPHEW, INC. 510(k) NO: K002274(TRADITIONAL) ATTN: TEDD GOSIAN PHONE NO : 508-261-3771 160 DASCOMB RD. SE DECISION MADE: 07-MAR-01 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SNAP MODEL 6 SNAP LABORATORIES, L.L.C. 510(k) NO: K002095(TRADITIONAL) ATTN: GIL RAVIV PHONE NO : 847-657-8100 3633 WEST LAKE AVE., SUITE 406 SE DECISION MADE: 02-MAR-01 GLENVIEW, IL 60025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CALEX CONDITIONER STEPHEN M. KORAL, D.M.D. 510(k) NO: K010176(TRADITIONAL) ATTN: STEPHEN M KORAL PHONE NO : 303-443-4984 2006 BROADWAY SE DECISION MADE: 27-MAR-01 BOULDER, CO 80302 510(k) STATEMENT DEVICE: SIMPLICITY SOFT Y INFUSION SET FOR USE WITH THE MINIMED INFUSION STERLING MEDIVATIONS, INC. 510(k) NO: K010373(ABBREVIATED) ATTN: JOEL DOUGLASS PHONE NO : 408-297-9474 180 FERNDALE ROAD SOUTH SE DECISION MADE: 13-MAR-01 WAYZATA, MN 55391 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALLOFIT ACETABULAR SYSTEM SULZER ORTHOPEDICS, INC. 510(k) NO: K003758(TRADITIONAL) ATTN: MITCHELL A DHORITY PHONE NO : 512-432-9202 9900 SPECTRUM DR. SE DECISION MADE: 07-MAR-01 AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRESSURE TRAK, MODEL 222-B SUNTECH MEDICAL INSTRUMENTS, INC. 510(k) NO: K010622(SPECIAL) ATTN: DAVID GALLICK PHONE NO : 919-782-3005 8917 GLENWOOD AVE. SE DECISION MADE: 29-MAR-01 RALEIGH, NC 27617 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SLT DIFFUSER FIBER SURGICAL LASER TECHNOLOGIES, INC. 510(k) NO: K010041(TRADITIONAL) ATTN: DAVIS WOODWARD PHONE NO : 215-619-3278 147 KEYSTONE DR. SE DECISION MADE: 07-MAR-01 MONTGOMERYVILLE, PA 18936 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: TAKE 1 SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K003808(TRADITIONAL) ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484 1717 WEST COLLINS AVENUE SE DECISION MADE: 01-MAR-01 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSTRUMENTS FOR LAPAROSCOPY 5 MM, 10 MM WITH COLOURED HANDLE, DE TEKNO MEDICAL OPTIK-CHIRURGIE GMBH510(k) NO: K003717(ABBREVIATED) ATTN: HARALD JUNG PHONE NO : UNTERER WINKEL 3 SE DECISION MADE: 01-MAR-01 WURMLINGEN, GERMANY 78573 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TERRAY STAINLESS STEEL ROD (STRAIGHT, L, RECTANGLE) TERRAY CORP. 510(k) NO: K003911(TRADITIONAL) ATTN: STEVE WANG PHONE NO : 613 623 3310 49 JACKSON LANE SE DECISION MADE: 13-MAR-01 ARNPRIOR, CANADA K7S3G8 510(k) STATEMENT DEVICE: SURSHIELD WINGED INFUSION SET TERUMO MEDICAL CORPORATION 510(k) NO: K010103(TRADITIONAL) ATTN: BARBARA SMITH PHONE NO : 410-392-7241 125 BLUE BALL ROAD SE DECISION MADE: 15-MAR-01 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENA EIA KIT RANGE THE BINDING SITE, LTD. 510(k) NO: K010146(TRADITIONAL) ATTN: JAY H GELLER PHONE NO : 310-449-1399 WEST TOWER, SUITE 4000 SE DECISION MADE: 01-MAR-01 2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT SANTA MONICA, CA 90404 DEVICE: ENA EIA KIT THE BINDING SITE, LTD. 510(k) NO: K010147(TRADITIONAL) ATTN: JAY H GELLER PHONE NO : 310-449-1399 WEST TOWER, SUITE 4000 SE DECISION MADE: 01-MAR-01 2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT SANTA MONICA, CA 90404 DEVICE: KENDALL 14.5 FR MAXID CUFFED DUAL LUMEN CATHETER THE KENDALL COMPANY 510(k) NO: K002901(TRADITIONAL) ATTN: PAUL EVANS PHONE NO : 508-261-8000 15 HAMPSHIRE STREET SE DECISION MADE: 28-MAR-01 MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERED SYNTHETIC VINYL PATIENT EXAM GLOVE TONG RUHN MEDICAL PRODUCTS CO., IN510(k) NO: K010663(TRADITIONAL) ATTN: ANTONIO L GIACCIO PHONE NO : 815-385-0100 1202 S. RTE 31 SE DECISION MADE: 30-MAR-01 MCHENRY, IL 60050 510(k) STATEMENT DEVICE: NEMIO TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K010631(TRADITIONAL) ATTN: PAUL BIGGINS PHONE NO : 714-730-5000 2441 MICHELLE DR. SE DECISION MADE: 15-MAR-01 P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA TUSTIN, CA 92781-2068 THIRD PARTY REVIEW DEVICE: SUSCEPTIBILITY TEST PANEL TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K004045(TRADITIONAL) ATTN: CYNTHIA C KNAPP PHONE NO : 800-216-9036 29299 CLEMENS RD. SUITE 1-K SE DECISION MADE: 06-MAR-01 WESTLAKE, OH 44145 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPECULITE/ORALLITE TRYLON CORP. 510(k) NO: K003995(TRADITIONAL) ATTN: MARTIN LONKY PHONE NO : 310-327-8820 970 WEST 190TH ST., SUITE 850 SE DECISION MADE: 16-MAR-01 TORRANCE, CA 90502-1037 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: E MOTION WHEELCHAIR DRIVE SYSTEM (POWER-ASSIST FOR MANUAL WHEELC ULRICH ALBER GMBH & CO. 510(k) NO: K003449(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511 55 NORTHERN BLVD SE DECISION MADE: 16-MAR-01 GREAT NECK, NY 12020 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRAPAK NEHA ULTRADENT PRODUCTS, INC. 510(k) NO: K010070(TRADITIONAL) ATTN: MARKUS R GEE PHONE NO : 800-552-5512 505 WEST 10200 SOUTH SE DECISION MADE: 15-MAR-01 SOUTH JORDAN, UT 84095 510(k) STATEMENT DEVICE: YORAMED, MODEL T-202 UNITED YORAM DISTRIBUTORS, INC. 510(k) NO: K002297(TRADITIONAL) ATTN: MORRIS MIZRAHI PHONE NO : 718-875-1179 602 DEGRAW ST. SE DECISION MADE: 15-MAR-01 BROOKLYN, NY 11217 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100 VALLEYLAB, INC. 510(k) NO: K010013(TRADITIONAL) ATTN: KEVIN RANDALL PHONE NO : 303-530-6253 5920 LONGBOW DR. SE DECISION MADE: 26-MAR-01 BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASPIRE COVERED STENT AND DELIVERY CATHETER VASCULAR ARCHITECTS, INC. 510(k) NO: K003173(TRADITIONAL) ATTN: KEVIN F MACDONALD PHONE NO : 408-392-7407 1830 BERING DR. SE DECISION MADE: 13-MAR-01 SAN JOSE, CA 95112-4226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISTAKON (HEFILCON C) CONTACT LENSES VISTAKON 510(k) NO: K010218(TRADITIONAL) ATTN: MICHAEL J TERSAK PHONE NO : 904-443-1402 7500 CENTURION PARKWAY SE DECISION MADE: 16-MAR-01 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA JACKSONVILLE, FL 32256 DEVICE: BREAS HA50 HUMIDIFIER, MODEL HA50 VITAL SIGNS, INC. 510(k) NO: K002454(ABBREVIATED) ATTN: THOMAS W DIELMANN PHONE NO : 303-790-4835 11039 EAST LANSING CIRCLE SE DECISION MADE: 07-MAR-01 ENGLEWOOD, CO 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERFADEX SOLUTION FOR ORGAN PRESERVATION VITROLIFE AB 510(k) NO: K000881(TRADITIONAL) ATTN: KARL A POSSELT PHONE NO : 908-284-2246 155 CIDER MILL ROAD SE DECISION MADE: 08-MAR-01 RINGOES, NJ 08551 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LORENZ FIDUCAIL SCREW WALTER LORENZ SURGICAL, INC. 510(k) NO: K010427(TRADITIONAL) ATTN: KIM REED PHONE NO : 904-741-4400 1520 TRADEPORT DR. SE DECISION MADE: 15-MAR-01 JACKSONVILLE, FL 32218 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM WESCOR, INC. 510(k) NO: K010031(SPECIAL) ATTN: WAYNE K BARLOW PHONE NO : 800-453-2775 459 SOUTH MAIN SE DECISION MADE: 20-MAR-01 LOGAN, UT 84321 510(k) STATEMENT DEVICE: MODIFICATION TO ACTICOAT FOAM DRESSING WESTAIM BIOMEDICAL, INC. 510(k) NO: K010447(SPECIAL) ATTN: STEVE CHARTIER PHONE NO : 603-775-7300 ONE HAMPTON RD. SUITE 302 SE DECISION MADE: 15-MAR-01 EXETER, NH 03833 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WHITTLESTONE BREASTPUMP WHITTLESTONE, INC. 510(k) NO: K002696(TRADITIONAL) ATTN: BRUCE MCKENDRY PHONE NO : 877-608-6455 601A STONE ROAD SE DECISION MADE: 21-MAR-01 BENICIA, CA 94510 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WISEBANDS SKIN CLOSURE DEVICE WISEBANDS LTD. 510(k) NO: K002315(TRADITIONAL) ATTN: MARY PAGE PHONE NO : 972 977 4715 P.O. BOX 978 SE DECISION MADE: 15-MAR-01 RA'ANANA, ISRAEL 43107 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMAGE IV DICOM IMAGE ARCHIVAL PACS NETWORK WITT BIOMEDICAL CORP. 510(k) NO: K010058(TRADITIONAL) ATTN: LORRAINE R FREDES PHONE NO : 407-253-5693 295 NORTH DR., SUITE H SE DECISION MADE: 21-MAR-01 MELBOURNE, FL 32934 510(k) STATEMENT DEVICE: NEWTOM QR-DVT 9000 ZEROBASE-USA LLC 510(k) NO: K003787(TRADITIONAL) ATTN: GREGORY W BOWMAN PHONE NO : 202-452-7000 815 CONNECTICUT AVENUE, NW SE DECISION MADE: 08-MAR-01 WASHINGTON,, DC 20006-4078 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEXGEN COMPLETE KNEE SOLUTION CROSS-LINKED POLYETHYLENE CRUCIATE ZIMMER, INC. 510(k) NO: K003910(TRADITIONAL) ATTN: STEPHEN MCKELVEY PHONE NO : 219-372-4944 P.O. BOX 708 SE DECISION MADE: 19-MAR-01 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 290 TOTAL WITH SUMMARIES 231 TOTAL WITH STATEMENTS 59
Updated 4/5/2001
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