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510(k)s Final Decisions Rendered for December 2003 |
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-DEC-2003 THROUGH 31-DEC-2003 DEVICE: IMMEDIATE STABILIZING IMPLANT (ISI) "O" CO., INC. 510(k) NO: K033392(TRADITIONAL) ATTN: DAVID D DALISE PHONE NO : 800-228-0477 600 PAISANO, N.E., SUITE A SE DECISION MADE: 10-DEC-03 ALBUQUERQUE, NM 87123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ERGO SRS 3D LINE USA, INC. 510(k) NO: K031281(TRADITIONAL) ATTN: NADER SALEHI PHONE NO : 410-581-6701 11419 CRONRIDGE RD., STE.15 SE DECISION MADE: 23-DEC-03 OWINGS MILLS, MD 21117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LT A-DEC, INC. 510(k) NO: K032572(TRADITIONAL) ATTN: TOM LOUISELL PHONE NO : 503-538-9471 2601 CRESTVIEW DR. SE DECISION MADE: 03-DEC-03 NEWBERG, OR 97132-9257 510(k) STATEMENT DEVICE: A-DEC 532/533 DELIVERY SYSTEM MODEL, 532/533 A-DEC, INC. 510(k) NO: K032756(TRADITIONAL) ATTN: TOM LOUISELL PHONE NO : 503-538-9471 2601 CRESTVIEW DR. SE DECISION MADE: 04-DEC-03 NEWBERG, OR 97132-9257 510(k) STATEMENT DEVICE: A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LI A-DEC, INC. 510(k) NO: K032757(TRADITIONAL) ATTN: TOM LOUISELL PHONE NO : 504-538-9471 2601 CRESTVIEW DR. SE DECISION MADE: 10-DEC-03 NEWBERG, OR 97132-9257 510(k) STATEMENT DEVICE: VERASOFT ES AALBA DENT, INC. 510(k) NO: K033356(TRADITIONAL) ATTN: VINCENT BENETTI PHONE NO : 707-864-3334 400 WATT DR. SE DECISION MADE: 30-DEC-03 CORDELIA, CA 94534 510(k) STATEMENT DEVICE: SELFX XPERT BILIARY STENT, MODELS EX8L2005, EX8L3005, EX8L4005, ABBOTT LABORATORIES 510(k) NO: K033537(SPECIAL) ATTN: JOANNA KUSKOWSKI PHONE NO : 650-474-3331 400 SAGINAW DRIVE SE DECISION MADE: 10-DEC-03 REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIE ABBOTT LABORATORIES 510(k) NO: K033576(SPECIAL) ATTN: PATRICIA MELERSKI PHONE NO : 847-938-3718 DEPT. 389, BLDG. J45-2N SE DECISION MADE: 04-DEC-03 200 ABBOTT PARK ROAD 510(k) SUMMARY AVAILABLE FROM FDA ABBOTT PARK, IL 60064-6133 DEVICE: ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP AND TEST DEVICE ACON LABORATORIES, INC. 510(k) NO: K033299(TRADITIONAL) ATTN: EDWARD TUNG PHONE NO : 858-535-2030 4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 12-DEC-03 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACRA-CUT XPRESS 120 ACRA CUT, INC. 510(k) NO: K032970(TRADITIONAL) ATTN: KENNETH M NICOLL PHONE NO : 603-672-3161 74 SPRING ROAD SE DECISION MADE: 08-DEC-03 AMHERST, NH 03031 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VANTAGE PRO ATTENUATION CORRECTION DEVICE ADAC LABORATORIES 510(k) NO: K033735(TRADITIONAL) ATTN: CHARLENE BRUMBAUGH PHONE NO : 408-468-3619 540 ALDER DR. SE DECISION MADE: 12-DEC-03 MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: LAMITRODE SPINAL CORD STIMULATION LEADS ADVANCED NEUROMODULATION SYSTEMS 510(k) NO: K033429(SPECIAL) ATTN: DANIELLE ALARCON PHONE NO : 972-309-8559 6501 WINDCREST DRIVE SUITE 100 SE DECISION MADE: 04-DEC-03 PLANO, TX 75024 510(k) STATEMENT DEVICE: AESKULISA ANA 8PRO AESKU, INC 510(k) NO: K032469(TRADITIONAL) ATTN: STANLEY AMMONS PHONE NO : 703-860-5057 8880 NORTHWEST 18TH TERRACE SE DECISION MADE: 16-DEC-03 MIAMI, FL 33172 510(k) STATEMENT DEVICE: INSTAREAD LITHIUM SYSTEM AKERS LABORATORIES, INC. 510(k) NO: K031579(TRADITIONAL) ATTN: ERIKA B AMMIRATI PHONE NO : 856-848-8698 201 GROVE RD. SE DECISION MADE: 19-DEC-03 THOROFARE, NJ 08086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EUSOL-C ALCHIMIA SRL 510(k) NO: K032422(TRADITIONAL) ATTN: GEORGE MYERS PHONE NO : 201-727-1703 377 ROUTE 17 S SE DECISION MADE: 15-DEC-03 HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEPARIN LOCK FLUSH SYRINGE AM2 PAT INC. 510(k) NO: K032417(TRADITIONAL) ATTN: DUSHYANT PATEL PHONE NO : 919-552-9689 9400 RANSDELL RD., SUITE 10 SE DECISION MADE: 23-DEC-03 RALEIGH, NC 27603 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TANGO, MODELS, BP1 AMERICAN BANTEX CORP. 510(k) NO: K031711(TRADITIONAL) ATTN: TRACY S BEST PHONE NO : 801-295-0748 994 NORTH MAIN STREET SE DECISION MADE: 18-DEC-03 BOUNTIFUL, UT 84010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREA AMERICAN GREEN DENT. MFG, INC. 510(k) NO: K033045(TRADITIONAL) ATTN: ANDREW ROWE PHONE NO : 323-265-7000 3432 E. 14TH STREET SE DECISION MADE: 23-DEC-03 LOS ANGELES, CA 90023 510(k) STATEMENT DEVICE: AMS LARGE PORE POLYPROPYLENE MESH AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K033636(TRADITIONAL) ATTN: ELSA A LINKE PHONE NO : 952-930-6000 10700 BREN RD., WEST SE DECISION MADE: 31-DEC-03 MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFESTYLES LIQUID PERSONAL LUBRICANT ANSELL HEALTHCARE, INC. 510(k) NO: K033076(TRADITIONAL) ATTN: LON D MCILVAIN PHONE NO : 334-615-2562 1635 INDUSTRIAL RD. SE DECISION MADE: 19-DEC-03 DOTHAN, AL 36303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LA500 BLUE LIGHT APOZA ENTERPRISE CO. LTD. 510(k) NO: K033201(TRADITIONAL) ATTN: SHIH MIN-TEH PHONE NO : 886 229 010620 6 F,NO.657, CHUANG CHENG ROAD SE DECISION MADE: 02-DEC-03 HSIN-CHUANG CITY 510(k) SUMMARY AVAILABLE FROM FDA TAIPEI HSIEN, CHINA (TAIWAN) 242 DEVICE: MEDICAL IMAGE DIGITIZER, MODEL 2908 ARRAY CORP. 510(k) NO: K033637(SPECIAL) ATTN: TAKASHI INAMI PHONE NO : 011 81 333203911 3-42-10 YOYOGI SE DECISION MADE: 17-DEC-03 SHIBUYA-KU, TOKYO, JAPAN 151-0053 510(k) STATEMENT DEVICE: ASEPTICO ENDOPEX V, MODEL AEU-40 ASEPTICO, INC. 510(k) NO: K030895(TRADITIONAL) ATTN: GRANT RAMALEY PHONE NO : 425-487-3157 8333 216TH ST., S.E. SE DECISION MADE: 03-DEC-03 WOODINVILLE, WA 98072 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATHENA PELVIC MUSCLE TRAINER II ATHENA FEMININE TECHNOLOGIES, INC.510(k) NO: K033256(ABBREVIATED) ATTN: BARBARA SARKIS PHONE NO : 925-254-6090 179 MORAGA WAY SE DECISION MADE: 30-DEC-03 ORINDA, CA 94563-3442 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALT LASER, MODEL VTR 75 AVICENNA LASER TECHNOLOGY, INC. 510(k) NO: K031612(TRADITIONAL) ATTN: BRUCE R COREN PHONE NO : 561-722-1153 1209 NORTH FLAGLER DRIVE SE DECISION MADE: 11-DEC-03 WEST PALM BEACH, FL 33401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKS AXON SYSTEMS, INC. 510(k) NO: K032741(TRADITIONAL) ATTN: HOWARD BAILIN PHONE NO : 631-436-5112 400-2200 OSER AVE. SE DECISION MADE: 16-DEC-03 HAUPPAUGE, NY 11788 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENTURI PHACO PACK BAUSCH & LOMB, INC. 510(k) NO: K033653(SPECIAL) ATTN: DENNIS POZZO PHONE NO : 636-226-3183 3365 TREE CT. INDUSTRIAL BLVD. SE DECISION MADE: 17-DEC-03 ST. LOUIS, MO 63122-6694 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BAY AREA HYPERSCIENCES BAY AREA HYPERSCIENCES, LLC 510(k) NO: K030713(ABBREVIATED) ATTN: EDWARD F GOOD PHONE NO : 714-332-6519 18213 SANDY COVE SE DECISION MADE: 19-DEC-03 HOUSTON, TX 77058 510(k) STATEMENT DEVICE: BAYER SPECIAL CHEMISTRY CONTROLS BAYER DIAGNOSTICS CORP. 510(k) NO: K033379(ABBREVIATED) ATTN: ANDRES HOLLE PHONE NO : 914-524-3494 511 BENEDICT AVE. SE DECISION MADE: 19-DEC-03 TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BAYER SPECIAL CHEMISTRY CALIBRATORS BAYER DIAGNOSTICS CORP. 510(k) NO: K033380(ABBREVIATED) ATTN: ANDRES HOLLE PHONE NO : 914-524-3494 511 BENEDICT AVE. SE DECISION MADE: 16-DEC-03 TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BAYER RAPIDLAB 1200 SYSTEM BAYER HEALTHCARE, LLC 510(k) NO: K031560(TRADITIONAL) ATTN: MARY E GRAY PHONE NO : 508-359-3825 63 NORTH ST. SE DECISION MADE: 17-DEC-03 MEDFIELD, MA 02052-1688 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BAYER CLINITEK STATUS ANALYZER BAYER HEALTHCARE, LLC 510(k) NO: K031947(TRADITIONAL) ATTN: MARY E GRAY PHONE NO : 508-359-3826 63 NORTH ST. SE DECISION MADE: 19-DEC-03 MEDFIELD, MA 02052-1688 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLINITEST HCG PREGNANCY TEST BAYER HEALTHCARE, LLC 510(k) NO: K032563(TRADITIONAL) ATTN: MARY GRAY PHONE NO : 508-359-3826 63 NORTH ST. SE DECISION MADE: 23-DEC-03 MEDFIELD, MA 02052 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75 BAYLIS MEDICAL CO., INC. 510(k) NO: K031949(TRADITIONAL) ATTN: AMANDA HARTLEY PHONE NO : 905 602 4875 5160 EXPLORER DR. #33 SE DECISION MADE: 10-DEC-03 MISSISSAUGA, ONTARIO, CANADA L4W 4510(k) STATEMENT DEVICE: BEBIG ISOSEED I-125 BEBIG ISOTOPEN-UND MEDIZINTECHNIK 510(k) NO: K033781(SPECIAL) ATTN: SVEN LANGER PHONE NO : 493 094 1084176 ROBERT-ROSSLE/STR.10 SE DECISION MADE: 30-DEC-03 BERLIN, GERMANY 13125 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY BECKMAN COULTER, INC. 510(k) NO: K033038(TRADITIONAL) ATTN: BRENT TABER PHONE NO : 952-368-1323 1000 LAKE HAZELTINE DR. SE DECISION MADE: 29-DEC-03 CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOAS BECKMAN COULTER, INC. 510(k) NO: K033603(TRADITIONAL) ATTN: VALYNDA MACHEN PHONE NO : 952-368-1383 1000 LAKE HAZELTINE DR. SE DECISION MADE: 19-DEC-03 CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM 0.5-64 UG/M BECTON, DICKINSON AND COMPANY 510(k) NO: K033558(TRADITIONAL) ATTN: BRADFORD SPRING PHONE NO : 410-316-4206 7 LOVETON CIR. SE DECISION MADE: 19-DEC-03 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: (MULTIPLE LABELS) POWDER-FREE VINYL EXAMINATION GLOVES BERNARD TECHNOLOGIES, INC. 510(k) NO: K033229(TRADITIONAL) ATTN: MICHAEL D LELAH, PHD PHONE NO : 312-337-0505 75 EAST WACKER DRIVE SE DECISION MADE: 17-DEC-03 CHICAGO, IL 60601 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MODEL BIO-RAD 510(k) NO: K033366(TRADITIONAL) ATTN: MARIA ZEBALLOS PHONE NO : 949-598-1367 9500 JERONIMO RD. SE DECISION MADE: 12-DEC-03 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 BIO-RAD 510(k) NO: K033387(TRADITIONAL) ATTN: MARIA ZEBALLOS PHONE NO : 949-598-1200 9500 JERONIMO RD. SE DECISION MADE: 02-DEC-03 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES) BIO-RAD 510(k) NO: K033404(TRADITIONAL) ATTN: MARIA ZEBALLOS PHONE NO : 949-598-1367 9500 JERONIMO RD. SE DECISION MADE: 12-DEC-03 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMNIOLENS BIO-TISSUE, INC. 510(k) NO: K032104(TRADITIONAL) ATTN: DAVID J BLOCH PHONE NO : 202-414-9209 1301 K STREET, N.W. SE DECISION MADE: 12-DEC-03 WASHINGTON, DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LARYNGEAL AUGMENTATION IMPLANT BIOFORM, INC. 510(k) NO: K033398(TRADITIONAL) ATTN: JAMES MILLER PHONE NO : 650-286-4000 1875 SOUTH GRANT ST.,SUITE 11O SE DECISION MADE: 12-DEC-03 SAN MATEO, CA 94402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MBCP BIOMATLANTE 510(k) NO: K032268(TRADITIONAL) ATTN: MYRIAM VINCENT PHONE NO : 332 280 20009 5, RUE EDOUARD BELIN SE DECISION MADE: 11-DEC-03 VIGNEUX DE BRETAGNE, FRANCE 44360 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PALACOS R BONE CEMENT WITH GENTAMICIN BIOMET, INC. 510(k) NO: K030086(TRADITIONAL) ATTN: LONNIE WITHAM PHONE NO : 574-372-1510 56 BELL DR. SE DECISION MADE: 17-DEC-03 PO BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: COMPRESS DISTAL FEMORAL REPLACEMENT BIOMET, INC. 510(k) NO: K031804(TRADITIONAL) ATTN: GARY BAKER PHONE NO : 574-267-6639 56 EAST BELL DR. SE DECISION MADE: 18-DEC-03 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: DISCOVERY ELBOW-MOSAIC DISTAL HUMERAL REPLACEMENT SYSTEM BIOMET, INC. 510(k) NO: K033280(TRADITIONAL) ATTN: PATRICIA SANDBORN BERES PHONE NO : 574-267-6639 56 EAST BELL DR. SE DECISION MADE: 19-DEC-03 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: CANNULATED ARTHRORIVET AND CANNULATED RC ARTHRORIVET BIOMET, INC. 510(k) NO: K033519(SPECIAL) ATTN: GARY BAKER PHONE NO : 574-267-6639 56 EAST BELL DR. SE DECISION MADE: 05-DEC-03 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MOD BIOSITE INCORPORATED 510(k) NO: K033383(TRADITIONAL) ATTN: JEFFREY R DAHLEN, PH.D. PHONE NO : 858-455-4808 11030 ROSELLE ST. SE DECISION MADE: 23-DEC-03 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER BIOTRONIK, INC. 510(k) NO: K033613(SPECIAL) ATTN: JON BRUMBAUGH PHONE NO : 888-345-0374 6024 JEAN RD. SE DECISION MADE: 08-DEC-03 LAKE OSWEGO, OR 97035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXACTRAC GATING BRAINLAB AG 510(k) NO: K033287(TRADITIONAL) ATTN: RAINER BIRKENBACH PHONE NO : 49 89 9915680 AMMERTHALSTRASSE 8 SE DECISION MADE: 19-DEC-03 HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRUNO ELECTRA-RIDE STAIRWAY ELEVATOR SYSTEM. MODEL SRE-1540 BRUNO INDEPENDENT LIVING AIDS, INC510(k) NO: K033752(SPECIAL) ATTN: RICHARD A KELLER PHONE NO : 262-953-5336 1780 EXECUTIVE DR. SE DECISION MADE: 12-DEC-03 P.O. BOX 84 510(k) STATEMENT OCONOMOWOC, WI 53066 DEVICE: BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM, MODEL CRE-2100 BRUNO INDEPENDENT LIVING AIDS, INC510(k) NO: K033829(SPECIAL) ATTN: RICHARD KELLER PHONE NO : 262-953-5336 1780 EXECUTIVE DR. SE DECISION MADE: 29-DEC-03 P.O. BOX 84 510(k) STATEMENT OCONOMOWOC, WI 53066 DEVICE: BTG SMARTEST GLUCOSE TEST SYSTEM BT MEDICAL 510(k) NO: K032029(TRADITIONAL) ATTN: DEBBIE CHENG PHONE NO : 886 4 23508198 6F-5 # 210 38TH ROAD SE DECISION MADE: 18-DEC-03 TAICHUNG INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA TAICHUNG, CHINA (TAIWAN) DEVICE: IRRIGATION CHANNEL TUBING, MODEL 100135 BYRNE MEDICAL, INC. 510(k) NO: K033695(TRADITIONAL) ATTN: J. HARVEY KNAUSS PHONE NO : 832-285-9423 11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 23-DEC-03 HOUSTON, TX 77071 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: FASTRAC GASTRIC ACCESS PORT KIT C.R. BARD, INC. 510(k) NO: K033562(SPECIAL) ATTN: THOMAS HIRTE, P.E. PHONE NO : 978-262-4867 129 CONCORD ROAD SE DECISION MADE: 12-DEC-03 BUILDING 3 510(k) SUMMARY AVAILABLE FROM FDA BILLERICA, MA 01821 DEVICE: MODIFICATION TO BARD AQUAGUIDE URETERAL CONDUIT C.R. BARD, INC. 510(k) NO: K033778(SPECIAL) ATTN: FRAN HARRISON PHONE NO : 770-784-6257 8195 INDUSTRIAL BLVD SE DECISION MADE: 30-DEC-03 COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CANDELA SMOOTHBEAM LASER SYSTEM CANDELA CORP. 510(k) NO: K030834(TRADITIONAL) ATTN: LORRAINE C PATROVIC PHONE NO : 508-358-7637 530 BOSTON POST RD. SE DECISION MADE: 03-DEC-03 WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PACS SOFTWARE SOLUTION 2003 CANON U.S.A., INC. 510(k) NO: K033624(SPECIAL) ATTN: SEAN M CURRY PHONE NO : 858-675-8200 16787 BERNARDO CENTER DRIVE SE DECISION MADE: 15-DEC-03 SUITE A1 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92128-3616 DEVICE: H/S CATHETER SET CATHETER RESEARCH, INC. 510(k) NO: K032835(TRADITIONAL) ATTN: JOHN A STEEN PHONE NO : 317-872-0074 6131 WEST 80TH ST. SE DECISION MADE: 11-DEC-03 INDIANAPOLIS, IN 46278 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CD LEYCOM PRESSURE/VOLUME CATHETERS CD LEYCOM BV 510(k) NO: K031599(SPECIAL) ATTN: T. LOPES PHONE NO : 31 79 3601780 ARGONSTRAAT 116 SE DECISION MADE: 09-DEC-03 ZOETERMEER, NETHERLANDS 2718 SP 510(k) STATEMENT DEVICE: CLINICAL LASETTE P-200 CELL ROBOTICS, INC. 510(k) NO: K033799(SPECIAL) ATTN: LINDA A BLAIR PHONE NO : 505-343-1131 2715 BROADBENT PARKWAY, NE SE DECISION MADE: 22-DEC-03 SUITE A-E 510(k) SUMMARY AVAILABLE FROM FDA ALBUQUERQUE, NM 87107 DEVICE: MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEM CENTERPULSE ORTHOPEDICS, INC. 510(k) NO: K033664(SPECIAL) ATTN: JEAN ASQUITH PHONE NO : 512-432-9900 9900 SPECTRUM DR. SE DECISION MADE: 17-DEC-03 AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM CHATTANOOGA GROUP 510(k) NO: K031077(TRADITIONAL) ATTN: CHERYL L BAGWELL PHONE NO : 423-870-7207 4717 ADAMS RD. SE DECISION MADE: 11-DEC-03 HIXSON, TN 37343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VECTRA (INTELECT) EPR ULTRASOUND CHATTANOOGA GROUP 510(k) NO: K031116(TRADITIONAL) ATTN: MICK DAVIS PHONE NO : 423-870-2281 4717 ADAMS RD. SE DECISION MADE: 03-DEC-03 P.O. BOX 489 510(k) STATEMENT HIXSON, TN 37343 DEVICE: DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) CHF SOLUTIONS, INC. 510(k) NO: K031689(TRADITIONAL) ATTN: AMY PETERSON PHONE NO : 763-463-4620 SUITE 170-7601 NORTHLAND DR. SE DECISION MADE: 23-DEC-03 BROOKLYN PARK, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) CHROMA VISION MEDICAL SYSTEMS INC.510(k) NO: K032113(TRADITIONAL) ATTN: DAVID DAVIS PHONE NO : 949-443-3355 33171 PASEO CERVEZA SE DECISION MADE: 23-DEC-03 SAN JUAN CAPISTRANO, CA 92675 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVE CIBA VISION CORP. 510(k) NO: K033701(SPECIAL) ATTN: ALICIA M PLESNARSKI PHONE NO : 678-415-3924 11440 JOHNS CREEK PKWY. SE DECISION MADE: 15-DEC-03 DULUTH, GA 30097-1556 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEARTOOTH DIGITAL X-RAY SYSTEM CLEARTOOTH ELECTRONICS, INC. 510(k) NO: K033147(TRADITIONAL) ATTN: GREG HOLLAND PHONE NO : 949-262-0411 3722 AVE. SAUSALITO SE DECISION MADE: 30-DEC-03 IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMPAK ACRYLIC REPAIR RESIN LIQUID CMP INDUSTRIES LLC. 510(k) NO: K033020(TRADITIONAL) ATTN: WILLIAM REGAN PHONE NO : 518-434-3147 413 NORTH PEARL ST. SE DECISION MADE: 19-DEC-03 ALBANY, NY 12207 510(k) STATEMENT DEVICE: COAPT ENDOTINE CHIN 3.5 DEVICE COAPT SYSTEMS, INC. 510(k) NO: K033524(TRADITIONAL) ATTN: LORI DONDIEGO PHONE NO : 650-461-7600 1820 EMBARCADERO RD. SE DECISION MADE: 18-DEC-03 PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL COBE CARDIOVASCULAR, INC. 510(k) NO: K033641(SPECIAL) ATTN: LYNNE LEONARD PHONE NO : 303-467-6194 14401 WEST 65TH WAY SE DECISION MADE: 11-DEC-03 ARVADA, CO 80004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003 COEUR MEDICAL 510(k) NO: K032920(TRADITIONAL) ATTN: DEBRA F MANNING PHONE NO : 252-946-1963 209 CREEKSIDE DR. SE DECISION MADE: 16-DEC-03 WASHINGTON, NC 27889 510(k) STATEMENT DEVICE: COMFORT VARIOUS OF STANDING WHEELCHAIR, HERO 2 COMFORT ORTHOPEDIC CO. LTD. 510(k) NO: K031618(TRADITIONAL) ATTN: ERIC H.C. LEE PHONE NO : 886 5 2892093 NO. 120 NAN SHIANG TSUEN, SE DECISION MADE: 18-DEC-03 SHOEI SHANG SHIANG 510(k) STATEMENT CHIA-YI, CHINA (TAIWAN) DEVICE: CONDUCTIVE EEG ELECTROLYTE COMPUMEDICS USA, LTD. 510(k) NO: K033052(ABBREVIATED) ATTN: ELVIRA GARCIA PHONE NO : 915-225-0303 7850 PASEO DEL NORTE SE DECISION MADE: 17-DEC-03 EL PASO, TX 79912 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XIO RADIATION TREATMENT PLANNING SYSTEM COMPUTERIZED MEDICAL SYSTEMS, INC.510(k) NO: K032762(TRADITIONAL) ATTN: KATHRYN STINSON PHONE NO : 314-993-0003 1145 CORPORATE LAKE DR. SE DECISION MADE: 02-DEC-03 ST. LOUIS, MO 63132-1716 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZILVER 518 BILIARY STENT COOK, INC. 510(k) NO: K033348(SPECIAL) ATTN: LELAND KEYT PHONE NO : 800-346-2686 750 DANIELS WAY SE DECISION MADE: 15-DEC-03 P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA BLOOMINGTON, IN 47402-0489 DEVICE: CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .03 CORDIS CORP. 510(k) NO: K033394(SPECIAL) ATTN: KAREN WILK PHONE NO : 908-412-7257 7 POWDER HORN DR. SE DECISION MADE: 22-DEC-03 WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OB1 OBSTETRICAL DOPPLER D. E. HOKANSON, INC. 510(k) NO: K033156(TRADITIONAL) ATTN: D. EUGENE HOKANSON PHONE NO : 425-882-1689 12840 N.E. 21ST PL. SE DECISION MADE: 09-DEC-03 BELLEVUE, WA 98005-1910 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI DADE BEHRING, INC. 510(k) NO: K033487(TRADITIONAL) ATTN: GEORGE M PLUMMER PHONE NO : 302-631-9798 P.O. BOX 6101 BUILDING 500 SE DECISION MADE: 24-DEC-03 GLASGOW BUSINESS COMMUNITY 510(k) SUMMARY AVAILABLE FROM FDA NEWARK,, DE 19714 DEVICE: AUTOMOVE, MODEL AM800 DANMETER A/S 510(k) NO: K032955(ABBREVIATED) ATTN: HANNE NIELSEN PHONE NO : 45 63 112930 KILDEMOSEVEJ 13 SE DECISION MADE: 15-DEC-03 ODENSE C, DENMARK DK-5000 510(k) STATEMENT DEVICE: ELPHA 4 CONTI DANMETER A/S 510(k) NO: K032988(ABBREVIATED) ATTN: HANNE NIELSEN PHONE NO : 45 63 112930 KILDEMOSEVEJ 13 SE DECISION MADE: 03-DEC-03 ODENSE C, DENMARK DK-5000 510(k) STATEMENT DEVICE: POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR DATEX-OHMEDA, INC. 510(k) NO: K031124(TRADITIONAL) ATTN: AL VAN HOUDT PHONE NO : 425-657-7200 5150 220TH AVE SE SE DECISION MADE: 04-DEC-03 ISSAQUAH, WA 98029 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BOBCAT PRO SCALER SYSTEM, MODEL G-130 DENTSPLY INTERNATIONAL 510(k) NO: K033705(SPECIAL) ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511 570 WEST COLLEGE AVE. SE DECISION MADE: 04-DEC-03 P.O. BOX 872 510(k) SUMMARY AVAILABLE FROM FDA YORK, PA 17404 DEVICE: PFZ PORCELAIN SYSTEM DENTSPLY INTL. 510(k) NO: K033553(SPECIAL) ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511 570 WEST COLLEGE AVE. SE DECISION MADE: 02-DEC-03 YORK, PA 17405-0872 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEPUY ASR RESURFACING FEMORAL HEADS DEPUY ORTHOPAEDICS, INC. 510(k) NO: K032659(TRADITIONAL) ATTN: NATALIE HECK PHONE NO : 574-372-7469 700 ORTHOPAEDIC DR. SE DECISION MADE: 04-DEC-03 P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0988 DEVICE: DEPUY GLOBAL CAP HA RESURFACING SHOULDER HUMERAL HEADS DEPUY ORTHOPAEDICS, INC. 510(k) NO: K033516(SPECIAL) ATTN: TIFFANI D ROGERS PHONE NO : 574-371-4927 700 ORTHOPAEDIC DR. SE DECISION MADE: 03-DEC-03 WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K033234(TRADITIONAL) ATTN: EDWARD LEVINE PHONE NO : 310-645-8200 5700 WEST 96TH ST. SE DECISION MADE: 12-DEC-03 LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MISSION CONTROLS DIAMOND DIAGNOSTICS, INC. 510(k) NO: K033063(TRADITIONAL) ATTN: LINDA M STUNDTNER PHONE NO : 508-429-0450 331 FISKE ST. SE DECISION MADE: 12-DEC-03 HOLLISTON, MA 01746 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPH DIDECO S.P.A. 510(k) NO: K033714(SPECIAL) ATTN: BARRY SALL PHONE NO : 781-434-4742 195 WEST ST. SE DECISION MADE: 11-DEC-03 WALTHAM, MA 02451-1163 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCUSOFT DIREX SYSTEMS CORP. 510(k) NO: K032171(TRADITIONAL) ATTN: LARISA GERSHTEIN PHONE NO : 188-874-7837 11 MERCER RD. SE DECISION MADE: 15-DEC-03 NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM) DISC-O-TECH MEDICAL TECHNOLOGIES, 510(k) NO: K032358(TRADITIONAL) ATTN: JONANTHAN S KAHN PHONE NO : 202-637-5794 555 THIRTEENTH STREET, NW SE DECISION MADE: 17-DEC-03 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFINITY GAMMAXL DRAEGER MEDICAL SYSTEMS, INC. 510(k) NO: K033600(SPECIAL) ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500 16 ELECTRONICS AVE. SE DECISION MADE: 11-DEC-03 DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM EBI, L.P. 510(k) NO: K033635(SPECIAL) ATTN: FREDERIC TESTA PHONE NO : 973-299-9300 100 INTERPACE PKWY. SE DECISION MADE: 03-DEC-03 PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS, EXTERNALLY S EDWARDS LIFESCIENCES, LLC. 510(k) NO: K032900(TRADITIONAL) ATTN: DAUN PUTNAM PHONE NO : 949-250-2217 ONE EDWARDS WAY SE DECISION MADE: 04-DEC-03 IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EDWARDS LIFESCIENCES VANTEX CENTRAL VENOUS CATHETERS WITH THERMI EDWARDS LIFESCIENCES, LLC. 510(k) NO: K033250(TRADITIONAL) ATTN: JASON SMITH PHONE NO : 949-250-2662 ONE EDWARDS WAY SE DECISION MADE: 30-DEC-03 IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLASMACURE BXE EELE LABORATORIES, LLC 510(k) NO: K033795(TRADITIONAL) ATTN: ROBERT GRASMAN PHONE NO : 631-244-0051 50 ORVILLE DRIVE SE DECISION MADE: 19-DEC-03 BOHEMIA, NY 11716 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: EPW FOLDABLE POWER WHEELCHAIR, EPW-03 EMG TECHNOLOGY CO., LTD. 510(k) NO: K033206(TRADITIONAL) ATTN: JEN KE-MIN PHONE NO : 886 3 5208829 NO. 58, FU-CHINU ST. SE DECISION MADE: 18-DEC-03 HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) STATEMENT DEVICE: MULTI-STRAP FULL FACE MASK ENGINEERED MEDICAL SYSTEMS 510(k) NO: K023683(TRADITIONAL) ATTN: PAUL DRYDEN PHONE NO : 317-335-3780 6329 W. WATERVIEW CT. SE DECISION MADE: 01-DEC-03 MCCORDSVILLE, IN 46055 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERICHEK BICARB PH REAGENT STRIPS ENVIRONMENTAL TEST SYSTEMS, INC. 510(k) NO: K031267(TRADITIONAL) ATTN: DAVID A MORRIS PHONE NO : 219-262-2060 23575 COUNTY RD. 106 SE DECISION MADE: 23-DEC-03 ELKHART, IN 46514 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAP3 BONE SUBSTITUTE MATERIAL ETEX CORP. 510(k) NO: K033138(TRADITIONAL) ATTN: PAMELA W ADAMS PHONE NO : 617-577-7270 38 SIDNEY STREET SE DECISION MADE: 02-DEC-03 CAMBRIDGE, MA 02139 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOPATH ENDOCUTTER GRAY CARTRIDGE, MODEL 6R45M/GRAY CARTRIDGE R ETHICON ENDO-SURGERY, INC. 510(k) NO: K033269(TRADITIONAL) ATTN: GEORGIA C ABERNATHY PHONE NO : 513-337-3179 4545 CREEK RD. SE DECISION MADE: 10-DEC-03 CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GYNECARE TVT OBTURATOR SYSTEM ETHICON, INC. 510(k) NO: K033568(SPECIAL) ATTN: SEAN O'BRYAN PHONE NO : 908-218-2456 ROUTE 22 WEST SE DECISION MADE: 08-DEC-03 SOMERVILLE, NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFIED COATED VICRYL* RAPIDE (POLYGLACTIN 910) SUTURE ETHICON, INC. 510(k) NO: K033746(SPECIAL) ATTN: REY LIBROJO PHONE NO : 908-218-3198 ROUTE 22 WEST SE DECISION MADE: 18-DEC-03 SOMERVILLE, NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECTRICAL MUSCLE STIMULATOR, MODELS N605 AND N607 EVERYWAY MEDICAL INSTRUMENTS CO., 510(k) NO: K033544(SPECIAL) ATTN: JAY MANSOUR PHONE NO : 770-777-4146 1308 MORNINGSIDE PARK DR. SE DECISION MADE: 10-DEC-03 ALPHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FACILAI VARIOUS MODELS OF SINGLE USE ACUPUNCTURE NEEDLE FACILAI ENTERPRISES LTD. 510(k) NO: K031818(TRADITIONAL) ATTN: KE-MIN JEN PHONE NO : 886 3 5208829 NO. 58, FU-CHIUN ST. SE DECISION MADE: 03-DEC-03 HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) STATEMENT DEVICE: MONA LISA ASPIRATION NEEDLE FERTILITY TECHNOLOGY RESOURCES, IN510(k) NO: K032208(TRADITIONAL) ATTN: CONSTANCE W STURGEON PHONE NO : 770-641-9487 4343 SHALLOWFORD RD. SE DECISION MADE: 09-DEC-03 SUITE D-4 510(k) STATEMENT MARIETTA, GA 30062 DEVICE: SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES FINK ENGINEERING PTY LTD 510(k) NO: K031649(ABBREVIATED) ATTN: W.T. WORKMAN PHONE NO : 210-490-6999 18111 COPPER RIDGE DRIVE SE DECISION MADE: 05-DEC-03 SAN ANTONIO, TX 78259 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO TELEGRAPH HUMERAL NAIL FOURNITURES HOSPITALIERES INDUSTRI510(k) NO: K033510(SPECIAL) ATTN: CHRISTINE QUENDEZ PHONE NO : 33 2 98556895 ZI DE KERNEVEZ-6 RUE NOBEL SE DECISION MADE: 03-DEC-03 QUIMPER, FRANCE 29000 510(k) STATEMENT DEVICE: SUBTALAR ARTHRORISIS IMPLANT FUTURA BIOMEDICAL 510(k) NO: K032902(TRADITIONAL) ATTN: LOUISE M FOCHT PHONE NO : 760-599-1670 990 PARK CENTER DR., SUITE H SE DECISION MADE: 15-DEC-03 VISTA, CA 92083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUBTALAR PEG IMPLANT FUTURA BIOMEDICAL 510(k) NO: K033046(TRADITIONAL) ATTN: LOUISE M FOCHT PHONE NO : 760-599-1670 990 PARK CENTER DR., SUITE H SE DECISION MADE: 23-DEC-03 VISTA, CA 92083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE GALT MEDICAL CORP. 510(k) NO: K033542(SPECIAL) ATTN: DAVID CATLIN PHONE NO : 972-271-5177 2475 MERRITT DR. SE DECISION MADE: 05-DEC-03 GARLAND, TX 75041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MYOLIGHT GE MEDICAL SYSTEMS F.I. HAIFA 510(k) NO: K033874(TRADITIONAL) ATTN: LAURENCE BIGIO PHONE NO : 4 856 3633 4 HAYOZMA ST. SE DECISION MADE: 30-DEC-03 TIRAT HACARMEL, ISRAEL 30200 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MODIFICATION TO UNITY NETWORK ID GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K033672(SPECIAL) ATTN: DIANA M THORSON PHONE NO : 714-247-4135 8200 WEST TOWER AVE. SE DECISION MADE: 18-DEC-03 MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENO ADVANTAGE GE MEDICAL SYSTEMS W-400 510(k) NO: K033400(TRADITIONAL) ATTN: LARRY A KROGER, PH.D. PHONE NO : 262-544-3894 3000 NORTH GRANDVIEW BLVD. SE DECISION MADE: 04-DEC-03 WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: GM3 SERIES IF TENS, MODEL GM3X2IF (WHERE X IS A PARAMETER OF DIF GEMORE TECHNOLOGY CO., LTD. 510(k) NO: K032719(TRADITIONAL) ATTN: BODEN S.P. LAI PHONE NO : 886 2 88091799 11 FL, NO. 29-5, SEC. 2 SE DECISION MADE: 10-DEC-03 CHUNG CHENG E. RD. 510(k) SUMMARY AVAILABLE FROM FDA TAN SHUI, TAIPEI HSIEN, CHINA (TAIWAN) DEVICE: GEM-STIM TENS, MODELS GM3XY AND GM3AXY GEMORE TECHNOLOGY CO., LTD. 510(k) NO: K032720(TRADITIONAL) ATTN: BODEN S.P. LAI PHONE NO : 886 2 88091799 11 FL, NO. 29-5, SEC. 2 SE DECISION MADE: 10-DEC-03 CHUNG CHENG E. RD. 510(k) SUMMARY AVAILABLE FROM FDA TAN SHUI, TAIPEI HSIEN, CHINA (TAIWAN) DEVICE: GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFE GEMORE TECHNOLOGY CO., LTD. 510(k) NO: K032994(TRADITIONAL) ATTN: BODEN S.P. LAI PHONE NO : 886 2 88091799 11 FL, NO. 29-5, SEC. 2 SE DECISION MADE: 16-DEC-03 CHUNG CHENG E. RD. 510(k) SUMMARY AVAILABLE FROM FDA TAN SHUI, TAIPEI HSIEN, CHINA (TAIWAN) DEVICE: TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC A GEN-PROBE, INC. 510(k) NO: K032194(TRADITIONAL) ATTN: WAYNE A KVETKOSKY PHONE NO : 858-410-8543 10210 GENETIC CENTER DR. SE DECISION MADE: 24-DEC-03 SAN DIEGO, CA 92121-4362 510(k) STATEMENT DEVICE: GEN-PROBE APTIMA COMBO 2 ASSAY GEN-PROBE, INC. 510(k) NO: K032554(TRADITIONAL) ATTN: ALAN MADERAZO PHONE NO : 858-410-8332 10808 WILLOW CT. SE DECISION MADE: 31-DEC-03 SAN DIEGO, CA 92127 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIAZYME LITHIUM ENZYMATIC ASSAY KIT GENERAL ATOMICS 510(k) NO: K033360(TRADITIONAL) ATTN: CHONG YUAN PHONE NO : 858-455-4754 3550 GENERAL ATOMICS COURT SE DECISION MADE: 23-DEC-03 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS GENERAL ELECTRIC CO. 510(k) NO: K033867(SPECIAL) ATTN: LARRY A KROGER PHONE NO : 262-544-3894 P.O. BOX 414 SE DECISION MADE: 19-DEC-03 MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VACUETTE QUICKSHIELD SAFETY TUBE HOLDER GREINER BIO-ONE VACUETTE NORTH AME510(k) NO: K033478(TRADITIONAL) ATTN: JUDI SMITH PHONE NO : 410-592-2060 PO BOX 103 SE DECISION MADE: 29-DEC-03 BALDWIN, MD 21013 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISU-LOCK 5MM CLIP APPLIER GYRX, LLC 510(k) NO: K033161(TRADITIONAL) ATTN: CORY EDWARDS PHONE NO : 904-641-2599 11222 ST. JOHNS INDUSTRIAL SE DECISION MADE: 18-DEC-03 PARKWAY N. 510(k) SUMMARY AVAILABLE FROM FDA JACKSONVILLE, FL 32246 DEVICE: HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP HARVARD CLINICAL TECHNOLOGY 510(k) NO: K033054(TRADITIONAL) ATTN: ERIC J FLACHBART PHONE NO : 508-655-2000 22 PLEASANT ST. SE DECISION MADE: 16-DEC-03 SOUTH NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: HEMEDEX FIXATION DEVICE HEMEDEX INCORPORATED 510(k) NO: K032127(TRADITIONAL) ATTN: DEBBIE IAMPIETRO PHONE NO : 508-435-9893 7 TIFFANY TRAIL SE DECISION MADE: 30-DEC-03 HOPKINTON, MA 01748 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERSYO.BOND HERAEUS KULZER, INC. 510(k) NO: K033629(TRADITIONAL) ATTN: CHERYL V ZIMMERMAN PHONE NO : 574-299-6662 4315 SOUTH LAFAYETTE BLVD. SE DECISION MADE: 22-DEC-03 SOUTH BEND, IN 46614-2517 510(k) STATEMENT DEVICE: VENUS FLOW HERAEUS KULZER, INC. 510(k) NO: K033665(TRADITIONAL) ATTN: CHERYL V ZIMMERMAN PHONE NO : 574-299-6662 4315 SOUTH LAFAYETTE BLVD. SE DECISION MADE: 30-DEC-03 SOUTH BEND, IN 46614 510(k) STATEMENT DEVICE: STRYKER SPINE MAPS SYSTEM HOWMEDICA OSTEONICS 510(k) NO: K032855(TRADITIONAL) ATTN: KAREN ARIEMMA PHONE NO : 201-831-5718 59 ROUTE 17 SE DECISION MADE: 10-DEC-03 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCORPIO LOW PROFILE TIBIAL TRAY HOWMEDICA OSTEONICS CORP. 510(k) NO: K032829(TRADITIONAL) ATTN: MARGARET F CROWE PHONE NO : 201-831-5580 59 ROUTE 17 SE DECISION MADE: 10-DEC-03 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYGIA HEALTH SERVICES REPROCESSED BLOOD PRESSURE CUFF HYGIA HEALTH SERVICES, INC. 510(k) NO: K032821(TRADITIONAL) ATTN: TRACY W COMAS PHONE NO : 205-314-3920 434 INDUSTRIAL LN. SE DECISION MADE: 05-DEC-03 BIRMINGHAM, AL 35211 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLC2000 CATHETER PATENCY DEVICE ICU MEDICAL, INC. 510(k) NO: K021692(TRADITIONAL) ATTN: ALISON D BURCAR PHONE NO : 949-366-2183 951 CALLE AMANECER SE DECISION MADE: 04-DEC-03 SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS) IMAGING THERAPEUTICS, INC. 510(k) NO: K033242(TRADITIONAL) ATTN: LYNDALL ERB PHONE NO : 650-286-4151 1720 SOUTH AMPHLETT BLVD. SE DECISION MADE: 31-DEC-03 SUITE 240 510(k) SUMMARY AVAILABLE FROM FDA SAN MATEO, CA 94402 DEVICE: IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY IG IMMCO DIAGNOSTICS, INC. 510(k) NO: K032571(TRADITIONAL) ATTN: KEVIN LAWSON PHONE NO : 716-691-0091 60 PINEVIEW DR. SE DECISION MADE: 24-DEC-03 BUFFALO, NY 14228 510(k) STATEMENT DEVICE: IMMUNETECH TOTAL IGE SYSTEM IMMUNETECH CORPORATION 510(k) NO: K032251(TRADITIONAL) ATTN: VIVIANNE NOETZEL PHONE NO : 858-756-8483 P.O. BOX 9433 SE DECISION MADE: 19-DEC-03 17394 VIA DEL BRAVO 510(k) SUMMARY AVAILABLE FROM FDA RANCHO SANTA FE, CA 92067 DEVICE: INSORB ABSORBABLE STAPLE, MODEL SP-B20 INCISIVE SURGICAL, INC. 510(k) NO: K033602(SPECIAL) ATTN: JIM PETERSON PHONE NO : 952-591-2543 14405 21ST AVE N. SE DECISION MADE: 16-DEC-03 SUITE 130 510(k) SUMMARY AVAILABLE FROM FDA PLYMOUTH, MN 55447 DEVICE: QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HI INSTRUMENTATION LABORATORY CO. 510(k) NO: K032663(TRADITIONAL) ATTN: CAROL MARBLE PHONE NO : 781-861-4467 113 HARTWELL AVE. SE DECISION MADE: 19-DEC-03 LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO COATEST FACTOR VIII INSTRUMENTATION LABORATORY CO. 510(k) NO: K033631(SPECIAL) ATTN: CAROL MARBLE PHONE NO : 781-861-4467 113 HARTWELL AVENUE SE DECISION MADE: 15-DEC-03 LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IXL DIABETES MANAGEMENT SYSTEM INSULET CORP. 510(k) NO: K031373(TRADITIONAL) ATTN: HOWARD HOLSTEIN PHONE NO : 202-637-5600 555 13TH ST., NW SE DECISION MADE: 18-DEC-03 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONTOUR-FLEX VALVE AND SHUNT SYSTEM INTEGRA NEUROSCIENCES IMPLANTS S.A510(k) NO: K033698(SPECIAL) ATTN: JUDITH E O'GRADY PHONE NO : 609-936-2311 311 ENTERPRISE DRIVE SE DECISION MADE: 17-DEC-03 PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHOENIX INFANT RADIANT WARMER, MODEL 100NWS INTERNATIONAL HOSPITAL SUPPLY CO. 510(k) NO: K033040(ABBREVIATED) ATTN: DAGMAR MASER PHONE NO : 31 20 4289591 AMSTEL 320-1 SE DECISION MADE: 17-DEC-03 AMSTERDAM, NETHERLANDS 1017AP 510(k) STATEMENT DEVICE: INTRA-LOCK HYDROXYAPATITE COATED IMPLANTS INTRA-LOCK INTERNATIONAL 510(k) NO: K031322(ABBREVIATED) ATTN: JEFFERY SAKOFF PHONE NO : 561-447-8282 1200 N. FEDERAL HWY SUITE#200 SE DECISION MADE: 23-DEC-03 BOCA RATON, FL 33432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSS INTRALUMINAL THERAPEUTICS, INC. 510(k) NO: K033708(SPECIAL) ATTN: PAMELA MISAJON PHONE NO : 760-918-1820 6354 CORTE DEL ABETO SE DECISION MADE: 11-DEC-03 SUITE A 510(k) SUMMARY AVAILABLE FROM FDA CARLSBAD, CA 92009 DEVICE: RH-950 IOMED, INC. 510(k) NO: K033192(TRADITIONAL) ATTN: CURTIS JENSEN PHONE NO : 801-975-1191 2441 SOUTH 3850 WEST, SUITE A SE DECISION MADE: 22-DEC-03 SALT LAKE CITY, UT 84120-9941 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHENOL RED STOCK SOLUTION IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K032887(TRADITIONAL) ATTN: WENDELL LEE PHONE NO : 800-437-5706 2511 DAIMLER ST. SE DECISION MADE: 19-DEC-03 SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: NUCAMMA RX IS2 RESEARCH, INC. 510(k) NO: K032779(TRADITIONAL) ATTN: VICTOR WOODBURN PHONE NO : 613 228 8755 20 GURDWARA RD., UNITS 3-10 SE DECISION MADE: 17-DEC-03 OTTAWA, ONTARIO, CANADA K2E 8B3 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLUEPHASE IVOCLAR VIVADENT, INC. 510(k) NO: K033520(TRADITIONAL) ATTN: DONNA MARIE HARTNETT PHONE NO : 716-691-2260 175 PINEVIEW DR. SE DECISION MADE: 05-DEC-03 AMHERST, NY 14228 510(k) STATEMENT DEVICE: JUSTWIN SCOOTER, JS-3013 JOY RIDE TECH CO., LTD. 510(k) NO: K032643(TRADITIONAL) ATTN: JEN KE-MIN PHONE NO : 886 352 08829 NO.58, FU-CHIUN ST SE DECISION MADE: 02-DEC-03 HSIN-CHU CITY, CHINA (TAIWAN) 510(k) STATEMENT DEVICE: JUSTWIN SCOOTER, JS-3014 JOY RIDE TECH CO., LTD. 510(k) NO: K032645(TRADITIONAL) ATTN: JEN KE-MIN PHONE NO : 886 352 08829 NO.58, FU-CHIUN ST SE DECISION MADE: 02-DEC-03 HSIN-CHU CITY, CHINA (TAIWAN) 510(k) STATEMENT DEVICE: KACEY INSULIN SYRINGE KACEY, INC. 510(k) NO: K033166(TRADITIONAL) ATTN: CHARLES F NEILSON, PHD PHONE NO : 803-328-0856 715 BUCKEYE TERRACE SE DECISION MADE: 12-DEC-03 ROCK HILL, SC 29732 510(k) STATEMENT DEVICE: GEM INSET PATELLAR COMPONENT KINAMED, INC. 510(k) NO: K032950(TRADITIONAL) ATTN: VINEET SARIN PHONE NO : 805-384-2748 820 FLYNN RD. SE DECISION MADE: 19-DEC-03 CAMARILLO, CA 93012 510(k) STATEMENT DEVICE: EPRICORD KURARAY MEDICAL INC. 510(k) NO: K033267(TRADITIONAL) ATTN: SATOSHI YAMAGUCHI PHONE NO : 212-986-2230 101 EAST 52ND STREET, 26TH FL. SE DECISION MADE: 22-DEC-03 NEW YORK, NY 10022 510(k) STATEMENT DEVICE: SET GRI-FILL 2.0-1 WAY; 2.0-2 WAYS; LUER CONNECTION TUBE LABORATORIOS GRIFOLS, S.A. 510(k) NO: K033682(TRADITIONAL) ATTN: SEBASTIAN GASCON PHONE NO : 34 93 5710100 POL. LEVANTE C/CAN GUASCH, 2 SE DECISION MADE: 17-DEC-03 PARETS DEL VALLES, BARCELONA, SPAI510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: GRI-BAG, GRI-BAG AP LABORATORIOS GRIFOLS, S.A. 510(k) NO: K033916(TRADITIONAL) ATTN: SEBASTIAN GASCON PHONE NO : 34 93 5710100 POL. LEVANTE C/CAN GUASCH, 2 SE DECISION MADE: 30-DEC-03 PARETS DEL VALLES, BARCELONA, SPAI510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: HYDROPHILIC GUIDEWIRE LAKE REGION MFG., INC. 510(k) NO: K033758(SPECIAL) ATTN: KAREN MORTENSEN PHONE NO : 952-448-5111 340 LAKE HAZELTINE DR. SE DECISION MADE: 19-DEC-03 CHASKA, MN 55318 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LEMAITRE VASCULAR STRAIGHT CAROTID SHUNT, MODEL 2002-01, 2002-05 LEMAITRE VASCULAR, INC. 510(k) NO: K033159(TRADITIONAL) ATTN: BRIAN K KEOGH PHONE NO : 781-221-2266 63 2ND AVENUE SE DECISION MADE: 19-DEC-03 BURLINGTON, MA 01803 510(k) STATEMENT DEVICE: ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATAL LIN-ZHI INTERNATIONAL, INC. 510(k) NO: K033094(TRADITIONAL) ATTN: CHENG-I LIN PHONE NO : 408-732-3856 687 NORTH PASTORIA AVE. SE DECISION MADE: 19-DEC-03 SUNNYVALE, CA 94085-2917 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIDENT RESECTION ABLATOR LINVATEC CORP. 510(k) NO: K033748(SPECIAL) ATTN: LAURA D KREJCI PHONE NO : 727-399-5234 11311 CONCEPT BLVD. SE DECISION MADE: 15-DEC-03 LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOANCHOR WITH DISPOSABLE DRIVER LINVATEC CORP. 510(k) NO: K033804(SPECIAL) ATTN: LAURA D KREJCI PHONE NO : 727-399-5234 11311 CONCEPT BLVD. SE DECISION MADE: 31-DEC-03 LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V LIVING DATA TECHNOLOGIES CORPORATI510(k) NO: K033657(SPECIAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502 55 NORTHERN BLVD. SUITE 200 SE DECISION MADE: 19-DEC-03 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVANTAGE PADDLE LIVINGSTON PRODUCTS, INC. 510(k) NO: K033202(ABBREVIATED) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 P.O. BOX 7007 SE DECISION MADE: 03-DEC-03 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPO2.COM OXIMETRY SENSORS, MULTIPLE MODELS MASIMO CORP. 510(k) NO: K033298(SPECIAL) ATTN: JAMES J CRONIN PHONE NO : 949-250-9688 2852 KELVIN AVE. SE DECISION MADE: 12-DEC-03 IRVINE, CA 92614-5826 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRSANSDERM IONTO SYSTEM MATTIOLI ENGINEERING CORP. 510(k) NO: K032968(TRADITIONAL) ATTN: MELISSA MAHALL PHONE NO : 301-623-2500 11800 BALTIMORE AVENUE SE DECISION MADE: 02-DEC-03 SUITE 105 510(k) SUMMARY AVAILABLE FROM FDA BELTSVILLE, MD 20705 DEVICE: SPECTRA QT: Q-SWITCHED ND: YAG LASER SYSTEM MAX ENGINEERING LTD. 510(k) NO: K032735(TRADITIONAL) ATTN: MAUREEN O'CONNELL PHONE NO : 978-207-1245 5 TIMBER LANE SE DECISION MADE: 03-DEC-03 NORTH READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMADERM MEDAFOR, INC. 510(k) NO: K033666(TRADITIONAL) ATTN: JENNIFER A MAY PHONE NO : 763-231-8263 2700 FREEWAY BLVD SE DECISION MADE: 17-DEC-03 SUITE 800 510(k) SUMMARY AVAILABLE FROM FDA MINNEAPOLIS, MN 55430 DEVICE: MEDICLUNG, RELEASE 1 MEDICSIGHT 510(k) NO: K033412(TRADITIONAL) ATTN: CAROL MACDONALD PHONE NO : 44 207 5985751 46 BERKELEY SQUARE SE DECISION MADE: 30-DEC-03 LONDON, UNITED KINGDOM W 1J 5AT 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAGNETIC RESONANCE REGULATOR, MODEL MRR1 MEDIPHYSICS PAIN CENTERS OF AMERIC510(k) NO: K032928(TRADITIONAL) ATTN: JAMES ROGERS PHONE NO : 949-215-0145 13 ORCHARD ROAD SE DECISION MADE: 19-DEC-03 UNIT 108 510(k) SUMMARY AVAILABLE FROM FDA LAKE FOREST, CA 92630 THIRD PARTY REVIEW DEVICE: UP-GRADE FOREHEAD THERMOMETER MEDISIM LTD. 510(k) NO: K032362(TRADITIONAL) ATTN: DALIA GIVONY PHONE NO : 972 267 99204 THE TECHNOLOGY PARK MANHAT SE DECISION MADE: 04-DEC-03 JERUSALEM, ISRAEL 96251 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PORTASCAN BLADDER SCANNER, MODEL PA00146 MEDIWATCH PLC 510(k) NO: K033906(TRADITIONAL) ATTN: ANDREW HOPKINS PHONE NO : 00 44 1788547888 COSFORD LANE SE DECISION MADE: 24-DEC-03 RUGBY, WARWICKSHIRE, UNITED KINGDO510(k) STATEMENT THIRD PARTY REVIEW DEVICE: DURAN BAND (MODEL H607H), DURAN RING (MODEL 610R), DURAN BAND (M MEDTRONIC HEART VALVES 510(k) NO: K032810(TRADITIONAL) ATTN: JULIE SHERMAN PHONE NO : 763-514-2876 8299 CENTRAL AVE., N.E. SE DECISION MADE: 05-DEC-03 M.S. P108 510(k) SUMMARY AVAILABLE FROM FDA MINNEAPOLIS, MN 55432-3576 DEVICE: MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K033322(SPECIAL) ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 15-DEC-03 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO EQUATION FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K033495(SPECIAL) ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 03-DEC-03 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMUNOCARDSTAT HPSA MERIDIAN BIOSCIENCE, INC. 510(k) NO: K032222(TRADITIONAL) ATTN: SUSAN ROLIH PHONE NO : 513-271-3700 3471 RIVER HILLS DR. SE DECISION MADE: 05-DEC-03 CINCINNATI, OH 45244 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 9 SECOND DIGITAL THERMOMETER, MODEL BT-S09 METATECH CO., LTD. 510(k) NO: K033082(TRADITIONAL) ATTN: GUENTER GINSBERG PHONE NO : 239-948-2001 11820 RED HIBISCUS DR. SE DECISION MADE: 03-DEC-03 BONITA SPRINGS, FL 34135 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: A1CNOW FOR HOME AND PROFESSIONAL USE METRIKA, INC. 510(k) NO: K033847(SPECIAL) ATTN: ERIKA AMMIRATI PHONE NO : 408-524-2255 510 OAKMEAD PKWY. SE DECISION MADE: 23-DEC-03 SUNNYVALE, CA 94085-4022 510(k) STATEMENT DEVICE: MICROLAB SPIROMETER MICRO DIRECT, INC. 510(k) NO: K031102(TRADITIONAL) ATTN: DAVID R STASZAK PHONE NO : 207-786-7808 803 WEBSTER ST. SE DECISION MADE: 01-DEC-03 LEWISTON, ME 04240 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYDROCOIL EMBOLIC SYSTEM (HES) MICROVENTION, INC. 510(k) NO: K033836(SPECIAL) ATTN: VINCENT CUTARELLI PHONE NO : 949-768-1184 75 COLUMBIA SE DECISION MADE: 30-DEC-03 ALISO VIEJO, CA 92656-1408 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MISONIX INC. FS 1000 RF ULTRASONIC SURGICAL ASPIRATOR SYSTEM MISONIX, INC. 510(k) NO: K032690(TRADITIONAL) ATTN: RONALD R MANNA PHONE NO : 631-694-9555 1938 NEW HIGHWAY SE DECISION MADE: 09-DEC-03 FARMINGDALE, NY 11735 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOORLDI INFRARED LASER DOPPLER IMAGER, MODEL MOORLD12-IR MOOR INSTRUMENTS LTD. 510(k) NO: K032841(TRADITIONAL) ATTN: DAVID BOGGETT PHONE NO : 44 129 735715 MILLWEY SE DECISION MADE: 10-DEC-03 AXMINSTER, DEVON, UNITED KINGDOM E510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR NEWMEDICAL TECHNOLOGY, INC. 510(k) NO: K030485(TRADITIONAL) ATTN: HAITHAM MATLOUB PHONE NO : 262-523-0521 N.14 W.23833 STONE RIDGE DR. SE DECISION MADE: 03-DEC-03 SUITE G100, MAIL BOX #1 510(k) SUMMARY AVAILABLE FROM FDA WAUKESHA, WI 53188 DEVICE: NON-CONTACT TONOMETER, MODEL NT-4000 NIDEK, INC. 510(k) NO: K031733(TRADITIONAL) ATTN: CAROL PATTERSON PHONE NO : 949-462-0900 21911 ERIE LN. SE DECISION MADE: 04-DEC-03 LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERABIEN ZR NORITAKE CO., INC. 510(k) NO: K031968(TRADITIONAL) ATTN: IVAN J WASSERMAN PHONE NO : 202-342-8400 3050 K STREET, NW, STE 400 SE DECISION MADE: 22-DEC-03 WASHINGTON, DC 20007 510(k) STATEMENT DEVICE: NOVELENS CONTACT LENS CLEANING ENHANCEMENT AND STORAGE ACCESSORY NOVELENS, INC. 510(k) NO: K032309(TRADITIONAL) ATTN: RICHARD E LIPPMAN PHONE NO : 240-683-3738 15825 SHADY GROVE ROAD SE DECISION MADE: 04-DEC-03 SUITE 30 510(k) SUMMARY AVAILABLE FROM FDA ROCKVILLE, MD 20850 DEVICE: SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM-8750 OPUS MEDICAL, INC. 510(k) NO: K033317(TRADITIONAL) ATTN: LAURA N KASPEROWICZ PHONE NO : 949-234-0400 27127 CALLE ARROYO, SUITE 1924 SE DECISION MADE: 30-DEC-03 SAN JUAN CAPISTRANO, CA 92675 510(k) STATEMENT DEVICE: VITOSS SCAFFOLD FOAM BONE GRAFT MATERIAL ORTHOVITA, INC. 510(k) NO: K032288(TRADITIONAL) ATTN: GINA M NAGVAJARA PHONE NO : 610-407-5251 45 GREAT VALLEY PKWY. SE DECISION MADE: 19-DEC-03 MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT ORTHOVITA, INC. 510(k) NO: K032812(TRADITIONAL) ATTN: DAVID J MCILHENNY PHONE NO : 610-407-5211 45 GREAT VALLEY PKWY. SE DECISION MADE: 08-DEC-03 MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MIDA ALGORITHM REV. B ORTIVUS AB 510(k) NO: K023414(TRADITIONAL) ATTN: KENNETH EKLUND PHONE NO : 46 8 4464535 ENHAGSSLINGAN 5 SE DECISION MADE: 05-DEC-03 TABY, SWEDEN SE-18325 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Z-SERIES MODULAR TOTAL HIP SYSTEM OSTEOIMPLANT TECHNOLOGY, INC. 510(k) NO: K032729(TRADITIONAL) ATTN: SAM SON PHONE NO : 410-785-0700 11201 PEPPER RD. SE DECISION MADE: 03-DEC-03 HUNT VALLEY, MD 21031-1201 510(k) STATEMENT DEVICE: TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TA PARALLAX MEDICAL, INC. 510(k) NO: K033230(SPECIAL) ATTN: LINDA PAUL PHONE NO : 831-439-0130 940 DISC DR. SE DECISION MADE: 12-DEC-03 SCOTTS VALLEY, CA 95066-4544 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: M2376A PHILIPS DEVICE LINK SYSTEM PHILIPS MEDICAL SYSTEMS 510(k) NO: K033680(SPECIAL) ATTN: HERBERT VAN DYK PHONE NO : 49 703 14631734 HEWLETT PACKARD STR. 2 SE DECISION MADE: 11-DEC-03 BOBLINGEN, GERMANY D71034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALLURA XPER FD20 PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K033737(TRADITIONAL) ATTN: LYNN HARMER PHONE NO : 425-487-7312 22100 BOTHELL EVERETT HIGHWAY SE DECISION MADE: 09-DEC-03 M.S. 415 510(k) SUMMARY AVAILABLE FROM FDA BOTHELL, WA 98021-8431 THIRD PARTY REVIEW DEVICE: ALLEGRO IMAGING SYSTEM PHILIPS MEDICAL SYSTEMS(CLEVELAND)510(k) NO: K033782(TRADITIONAL) ATTN: CHRISTOF LITTWITZ PHONE NO : 440-483-3585 595 MINER RD. SE DECISION MADE: 19-DEC-03 CLEVELAND, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50L PIE MEDICAL 510(k) NO: K033604(TRADITIONAL) ATTN: COLLEEN DENSMORE PHONE NO : 317-849-1916 7992 CASTLEWAY DRIVE SE DECISION MADE: 15-DEC-03 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO SLIM GLIDING NAIL SYSTEM PLUS ORTHOPEDICS 510(k) NO: K033763(SPECIAL) ATTN: NEIL DELANEY PHONE NO : 888-741-7587 6055 LUSK BLVD. SE DECISION MADE: 18-DEC-03 SAN DIEGO, CA 92121-2700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSF PORTEX LTD. 510(k) NO: K033084(TRADITIONAL) ATTN: STEVE OGILVIE PHONE NO : 00 440 1303260551 MILITARY ROAD SE DECISION MADE: 19-DEC-03 HYTHE, KENT, UNITED KINGDOM CT21 6510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAFYRE VS AND SAFYRE T PROMEDON 510(k) NO: K033691(SPECIAL) ATTN: DEBBIE IAMPIETRO PHONE NO : 508-435-9893 7 TIFFANY TRAIL SE DECISION MADE: 19-DEC-03 HOPKINTON, MA 01748 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT PULPDENT CORPORATION 510(k) NO: K032953(TRADITIONAL) ATTN: KENNETH J BERK PHONE NO : 617-926-6666 80 OAKLAND ST. SE DECISION MADE: 10-DEC-03 WATERTOWN, MA 02472 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM R&B SURGICAL SOLUTIONS, LLC. 510(k) NO: K032752(TRADITIONAL) ATTN: KAREN E WARDEN PHONE NO : 440-729-8457 8202 SHERMAN ROAD SE DECISION MADE: 03-DEC-03 CHESTERLAND, OH 44026 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RADIANCY ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT ASSEMBLY RADIANCY (ISRAEL) LTD. 510(k) NO: K032205(TRADITIONAL) ATTN: JONATHAN S KAHN PHONE NO : 202-637-5794 555 THIRTEENTH STREET, NW SE DECISION MADE: 11-DEC-03 WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RANDOX RX DAYTONA RANDOX LABORATORIES, LTD. 510(k) NO: K024014(TRADITIONAL) ATTN: LYNNE HAMILTON PHONE NO : 44 28 94422413 55 DIAMOND RD. SE DECISION MADE: 04-DEC-03 CRUMLIN, COUNTY ANTRIM, UNITED KIN510(k) STATEMENT DEVICE: RANDOX EVIDENCE RANDOX LABORATORIES, LTD. 510(k) NO: K030360(TRADITIONAL) ATTN: PAULINE ARMSTRONG PHONE NO : 44 28 94 422413 55 DIAMOND RD. SE DECISION MADE: 23-DEC-03 CRUMLIN, COUNTY ANTRIM, UNITED KIN510(k) STATEMENT DEVICE: EVOLVE RELIANCE ORTHODONTIC PRODUCTS, INC510(k) NO: K033551(SPECIAL) ATTN: BENJAMIN LICHTENWALNER PHONE NO : 847-534-6146 1100 W. IRVING PARK RD. SE DECISION MADE: 16-DEC-03 SCHAUMBURG, IL 60193 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MIRAGE ACTIVA MASK RESMED LTD. 510(k) NO: K032916(TRADITIONAL) ATTN: DAVID D'CRUZ PHONE NO : 858-746-2238 14040 DANIELSON ST. SE DECISION MADE: 04-DEC-03 POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEANER II ROTATIONAL THROMBECTOMY SYSTEM REX MEDICAL 510(k) NO: K033793(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001 55 NORTHERN BLVD. SE DECISION MADE: 16-DEC-03 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 11021 THIRD PARTY REVIEW DEVICE: MESACUP-2 TEST JO-1, MODEL 10756 RHIGENE, INC. 510(k) NO: K033528(TRADITIONAL) ATTN: NANCI DEXTER PHONE NO : 303-457-4345 12061 TEJON ST. SE DECISION MADE: 22-DEC-03 WESTMINSTER, CO 80234 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTOGEL PAD RICH-MAR CORP. 510(k) NO: K031018(TRADITIONAL) ATTN: DAVID RICHARDS PHONE NO : 918-543-2222 15499 EAST 590TH RD. SE DECISION MADE: 08-DEC-03 P.O. BOX 879 510(k) STATEMENT INOLA, OK 74036-0879 DEVICE: UNIVERSAL OPERATING HYSTERISCOPE SET BY SOLIMA-ZUPI, CONSISTING RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K033113(TRADITIONAL) ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113 353 CORPORATE WOODS PKWY. SE DECISION MADE: 23-DEC-03 VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UB 140 RIVERTRAIL MOBILITY 510(k) NO: K033827(TRADITIONAL) ATTN: CLARK STANCIL PHONE NO : 501-745-6790 369 FACTORY ROAD SE DECISION MADE: 18-DEC-03 CLINTON, AR 72031 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS ROCHE DIAGNOSTICS CORP. 510(k) NO: K033246(ABBREVIATED) ATTN: KERWIN KAUFMAN PHONE NO : 317-521-7637 9115 HAGUE RD. SE DECISION MADE: 02-DEC-03 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS ROCHE DIAGNOSTICS CORP. 510(k) NO: K033306(ABBREVIATED) ATTN: KERWIN KAUFMAN PHONE NO : 317-521-7637 9115 HAGUE RD. SE DECISION MADE: 15-DEC-03 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HDL-CHOLESTEROL PLUS 2ND GENERATION ROCHE DIAGNOSTICS CORP. 510(k) NO: K033610(SPECIAL) ATTN: SHERRI L COENEN PHONE NO : 317-521-3831 9115 HAGUE RD. SE DECISION MADE: 05-DEC-03 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FACTOR II (PROTHROMBIN) G20210A KIT ROCHE DIAGNOSTICS CORP. 510(k) NO: K033612(TRADITIONAL) ATTN: ROBERT A GREGG PHONE NO : 317-521-2386 9115 HAGUE RD. SE DECISION MADE: 18-DEC-03 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIGHTCYCLER INSTRUMENT VERSION 1.2 ROCHE DIAGNOSTICS CORP. 510(k) NO: K033734(TRADITIONAL) ATTN: ROBERT A GREGG PHONE NO : 317-521-2386 9115 HAGUE RD. SE DECISION MADE: 17-DEC-03 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: B&R DEVICE RONVIG A/S 510(k) NO: K032925(TRADITIONAL) ATTN: ANNETTE RAVN NIELSEN PHONE NO : 457 589 5711 GL. VEJLEVEJ 57-59 SE DECISION MADE: 22-DEC-03 DAUGAARD, DENMARK 8721 510(k) STATEMENT DEVICE: FLUID FILLED TEETHERS ROYAL KING INFANT PRODUCTS CO. LTD510(k) NO: K031094(TRADITIONAL) ATTN: DALBIR SINGH KHURANA PHONE NO : 66 2 8924506 73/4 M00 1 KHAELIE SE DECISION MADE: 08-DEC-03 KRATHUMBAEN, SAMUTSAKOR, THAILAND 510(k) STATEMENT DEVICE: INTERMITTENT URETHRAL CATHETERS RUSCH INTL. 510(k) NO: K033023(TRADITIONAL) ATTN: RICK LYKINS PHONE NO : 603-532-0204 50 PLANTATION DR. SE DECISION MADE: 23-DEC-03 JAFFERY, NH 03452 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPIROTEL, MODEL 29-1020 SDI DIAGNOSTICS, INC. 510(k) NO: K031643(TRADITIONAL) ATTN: MICHAEL J BOYLE PHONE NO : 508-238-7033 10 HAMPDEN DR. SE DECISION MADE: 09-DEC-03 EASTON, MA 02375 510(k) STATEMENT DEVICE: MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1 SECTRA-IMTEC AB 510(k) NO: K033712(SPECIAL) ATTN: CARL ALLETTO PHONE NO : 214-262-4209 1600 MANCHESTER WAY SE DECISION MADE: 23-DEC-03 CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLARITY PET SHARED P.E.T. IMAGING, LLC 510(k) NO: K032866(TRADITIONAL) ATTN: RUSS PAGANO PHONE NO : 202-546-1262 710 A STREET, NE SE DECISION MADE: 12-DEC-03 WASHINGTON, DC 20002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHELHIGH NO-REACT BIOCUFF SHELHIGH, INC. 510(k) NO: K032893(TRADITIONAL) ATTN: SHLOMO GABBAY PHONE NO : 908-206-8906 650 LIBERTY AVE. SE DECISION MADE: 19-DEC-03 UNION, NJ 07083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LATERAL ANGIOGRAPHIC C-ARM SUPPORT MH-400 SHIMADZU CORP. 510(k) NO: K033184(TRADITIONAL) ATTN: TAKESHI OZAKI PHONE NO : 310-217-8855 20101 SOUTH VERMONT AVE. SE DECISION MADE: 09-DEC-03 TORRANCE, CA 90502-1328 510(k) STATEMENT DEVICE: SIENET COSMOS SIEMENS AG, MEDICAL SOLUTIONS 510(k) NO: K033831(TRADITIONAL) ATTN: EVA-MARIA REITER PHONE NO : 49 913 1842680 HENKESTRASSE 127 SE DECISION MADE: 19-DEC-03 ERLANGEN, GERMANY D-91052 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SYNGO PERFUSION-CT SIEMENS AG, MEDICAL SOLUTIONS 510(k) NO: K033832(TRADITIONAL) ATTN: RUDIGER KORNER PHONE NO : 49 919 1189355 SIEMENSSTRASSE 1 SE DECISION MADE: 23-DEC-03 FORCHHEIM, GERMANY D 91301 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: AIACT KIT SIENCO, INC. 510(k) NO: K032952(TRADITIONAL) ATTN: BARBARA DEBIASE PHONE NO : 303-420-1148 11485-A WEST 48TH AVE. SE DECISION MADE: 12-DEC-03 WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOTILITY VISUALIZATION SYSTEM SIERRA SCIENTIFIC INSTRUMENTS, INC510(k) NO: K031169(TRADITIONAL) ATTN: SEAN M CURRY PHONE NO : 858-675-8200 16787 BERNARDO CENTER DR. SE DECISION MADE: 12-DEC-03 SUITE A-1 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92128 DEVICE: SIROSON L AND SIROSONIC L ULTRASONIC SCALERS SIRONA DENTAL SYSTEMS GMBH 510(k) NO: K033640(TRADITIONAL) ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434 49 PLAIN ST. SE DECISION MADE: 12-DEC-03 NORTH ATTLEBORO, MA 02760-4153 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIGHTWAVE INFRARED LAMPS LW10D AND LW30D SKYTECH ENTERPRISES, INC. 510(k) NO: K024027(TRADITIONAL) ATTN: LEWIS WARD PHONE NO : 303-530-3279 4655 KIRKWOOD COURT SE DECISION MADE: 03-DEC-03 BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW IUR MORCELLATION SYSTEM SMITH & NEPHEW, INC. 510(k) NO: K031787(TRADITIONAL) ATTN: JANICE HASELTON PHONE NO : 978-749-1494 150 MINUTEMAN RD. SE DECISION MADE: 02-DEC-03 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AN SMITH & NEPHEW, INC. 510(k) NO: K033669(SPECIAL) ATTN: DAVID HENLEY PHONE NO : 901-399-6487 1450 BROOKS RD. SE DECISION MADE: 10-DEC-03 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDISCOPE SOMETECH CORPORATION 510(k) NO: K031436(TRADITIONAL) ATTN: KI CHEOL HAN PHONE NO : 770-825-0100 6669 PEACHTREE INDUSTRIAL BLVD SE DECISION MADE: 19-DEC-03 SUITE J 510(k) SUMMARY AVAILABLE FROM FDA NORCROSS, GA 30092 DEVICE: SPECTRA PULSED DIODE LASER, MODEL DR-1 SPECTRAGENICS, INC. 510(k) NO: K032846(TRADITIONAL) ATTN: ROBERT E GROVE PHONE NO : 925-847-1762 7083 COMMERCE CIRCLE SE DECISION MADE: 11-DEC-03 SUITE 1 510(k) SUMMARY AVAILABLE FROM FDA PLEASANTON, CA 94588 DEVICE: REVOLUTION SPINAL FIXATION SYSTEM SPINAL INNOVATIONS, INC. 510(k) NO: K032219(TRADITIONAL) ATTN: JOE CLIFT PHONE NO : 901-373-8855 7850 STAGE HILLS BLVD. SE DECISION MADE: 19-DEC-03 SUITE 105 510(k) SUMMARY AVAILABLE FROM FDA BARTLETT, TN 38133-4029 DEVICE: FIDJI SMALL CEMENT RESTRICTOR SPINE NEXT SA 510(k) NO: K030767(TRADITIONAL) ATTN: DIANE JOHNSON PHONE NO : 410-409-8276 104 GREENWOOD CREEK RD. SE DECISION MADE: 22-DEC-03 QUEENSTOWN, MD 21658 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIDJI LARGE CEMENT RESTRICTOR SPINE NEXT SA 510(k) NO: K030871(TRADITIONAL) ATTN: DIANE JOHNSON PHONE NO : 410-409-8276 104 GREENWOOD CREEK RD. SE DECISION MADE: 22-DEC-03 QUEENSTOWN, MD 21658 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DECATHLON TWIN LUMEN HEMODIALYSIS WITH SEPARATED TIPS, MODELS DE SPIRE BIOMEDICAL, INC. 510(k) NO: K032061(TRADITIONAL) ATTN: DONALD FICKETT PHONE NO : 781-275-6001 ONE PATRIOTS PARK SE DECISION MADE: 23-DEC-03 BEDFORD, MA 01730-2396 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LOTUS SRA DEVELOPMENTS, LTD. 510(k) NO: K032424(TRADITIONAL) ATTN: T WHIT ATHEY PHONE NO : 301-570-0013 2305 GOLD MINE ROAD SE DECISION MADE: 16-DEC-03 BROOKEVILLE, MD 20833 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER VERTEBRAL BODY AND BONE BIOPSY KITS, STRYKER CAPTURE BOD STRYKER CORP. 510(k) NO: K032943(TRADITIONAL) ATTN: DANNIELLE WHEELER PHONE NO : 269-323-7700 4100 E. MILHAM AVE. SE DECISION MADE: 17-DEC-03 KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER MINI-MENDER MENISCAL REPAIR SYSTEM STRYKER ENDOSCOPY 510(k) NO: K032901(ABBREVIATED) ATTN: MELISSA MURPHY PHONE NO : 408-754-2000 5900 OPTICAL CT. SE DECISION MADE: 02-DEC-03 SAN JOSE, CA 95138 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SISS INC. (D.B.A. MEDISISS) REPROCESSED ELECTROSURGICAL INSTRUME SURGICAL INSTRUMENTS SERVICE AND S510(k) NO: K031869(TRADITIONAL) ATTN: MARY ANN BARKER PHONE NO : 541-549-4164 723 CURTIS CT, SUITE A SE DECISION MADE: 24-DEC-03 SISTERS, OR 97759 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DEGALL II GALLBLADDER EXTRACTOR SURGICON, INC. 510(k) NO: K033359(TRADITIONAL) ATTN: CURTIS RAYMOND PHONE NO : 203-380-8771 400 LONG BEACH BLVD. SE DECISION MADE: 19-DEC-03 STRATFORD, CT 06615 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISION-TECH YZ SLIT LAMP, MODEL 66 SUZHOU 66 VISION-TECH CO., LTD 510(k) NO: K033190(TRADITIONAL) ATTN: ERIC LUO PHONE NO : 214-632-0636 6833 SAINT LAWRENCE STREET SE DECISION MADE: 04-DEC-03 PLANO, TX 75024 510(k) STATEMENT DEVICE: POLARIS WR SYNERON MEDICAL LTD. 510(k) NO: K031671(TRADITIONAL) ATTN: AMIR WALDMAN PHONE NO : 972 4 9097424 POB 550 SE DECISION MADE: 01-DEC-03 YOKNEAM ELITE, ISRAEL 20692 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO AURORA DS SYNERON MEDICAL LTD. 510(k) NO: K033586(SPECIAL) ATTN: AMIR WALDMAN PHONE NO : 972 67 404616 P.O. BOX 550 SE DECISION MADE: 10-DEC-03 INDUSTRIAL ZONE 510(k) SUMMARY AVAILABLE FROM FDA YOKNEAM ILLIT, ISRAEL 20692 DEVICE: TAIWAN KING STRONG TC 03 MECHANICAL WHEELCHAIR TAIWAN KING STRONG CO., LTD. 510(k) NO: K033031(TRADITIONAL) ATTN: JEN KE-MIN PHONE NO : 886 3 5208829 NO. 58, FU-CHIUN ST. SE DECISION MADE: 02-DEC-03 HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) STATEMENT DEVICE: TAIWAN KING STRONG POWERED WHEELCHAIR, TP 01 TAIWAN KING STRONG CO., LTD. 510(k) NO: K033100(TRADITIONAL) ATTN: JEN KE-MIN PHONE NO : 886 3 5208829 NO. 58, FU-CHIUN ST. SE DECISION MADE: 02-DEC-03 HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VINYL EXAMINATION GLOVES, POWDERED TANGSHAN TRANSOCEAN PLASTIC PRODUC510(k) NO: K033308(TRADITIONAL) ATTN: IRIS YANG PHONE NO : 863 154 109985 NO. 188 BENHU ROAD SE DECISION MADE: 22-DEC-03 LUANNAN COUNTY 510(k) STATEMENT TANGSHAN CITY; HEBEI, CHINA 063500 DEVICE: GLIDESHEATH TERUMO CORP. 510(k) NO: K033681(SPECIAL) ATTN: MARK UNTERREINER PHONE NO : 410-392-7213 125 BLUE BALL RD. SE DECISION MADE: 11-DEC-03 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROGREAT TERUMO MEDICAL CORP. 510(k) NO: K033583(SPECIAL) ATTN: MARK UNTERREINER PHONE NO : 410-392-7213 125 BLUE BALL RD. SE DECISION MADE: 12-DEC-03 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REDLINE ANTHRAX ALERT TEST TETRACORE, INC 510(k) NO: K030370(TRADITIONAL) ATTN: BEVERLY L MANGOLD PHONE NO : 301-258-7553 11 FIRSTFIELD RD. SE DECISION MADE: 09-DEC-03 SUITE C 510(k) SUMMARY AVAILABLE FROM FDA GAITHERSBURG,, MD 20878 DEVICE: THAI NIPPON EXTRA STRENGTH MALE LATEX CONDOM THAI NIPPON RUBBER INDUSTRY CO., L510(k) NO: K032909(ABBREVIATED) ATTN: ELI J CARTER PHONE NO : 919-544-4098 1219 LITTLE CREEK RD. SE DECISION MADE: 16-DEC-03 DURHAM, NC 27713 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C-GRAFT THE CLINICIAN'S PREFERENCE LLC 510(k) NO: K033110(TRADITIONAL) ATTN: CHARLES L MORIN PHONE NO : 415-957-0101 388 MARKET STREET, SUITE 500 SE DECISION MADE: 10-DEC-03 SAN FRANCISCO, CA 94111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIA THERASENSE, INC. 510(k) NO: K031260(TRADITIONAL) ATTN: DONNA K TEMPLEMAN PHONE NO : 510-239-2670 1360 SOUTH LOOP RD. SE DECISION MADE: 19-DEC-03 ALAMEDA, CA 94502-7000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM TOPCON MEDICAL SYSTEMS, INC. 510(k) NO: K031831(TRADITIONAL) ATTN: DONALD H WINFIELD PHONE NO : 201-261-9450 37 WEST CENTURY RD. SE DECISION MADE: 19-DEC-03 PARAMUS, NJ 07652 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AEQUALIS SHOULDER FRACTURE SYSTEM TORNIER S.A. 510(k) NO: K032679(SPECIAL) ATTN: MIRELLE LEMERY PHONE NO : 003 347 6613898 ZIRST-161, RUE LAVOISIER SE DECISION MADE: 15-DEC-03 MONTBONNOT, FRANCE 38330 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGR TRANSONIC SYSTEMS, INC. 510(k) NO: K033424(SPECIAL) ATTN: MARK S ALSBERGE PHONE NO : 607-257-5300 34 DUTCH MILL RD. SE DECISION MADE: 11-DEC-03 WARREN RD. BUSINESS PARK 510(k) SUMMARY AVAILABLE FROM FDA ITHACA, NY 14850 DEVICE: APEX DETECTOR ELECTRONICS & ACQUISITION INTERFACE, MODEL XL-4 TRANSPHOTON CORPORATION 510(k) NO: K033001(TRADITIONAL) ATTN: SCOTT JENNINGS PHONE NO : 978-985-2532 37 ELECTRIC AVENUE SE DECISION MADE: 24-DEC-03 LUNENBURG, MA 01462 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S280 TUNG KENG ENTERPRISE CO., LTD. 510(k) NO: K033220(TRADITIONAL) ATTN: JEN KE-MIN PHONE NO : 886 3 5208829 NO. 58 FU-CHIUN ST. SE DECISION MADE: 18-DEC-03 HSIN-CHU CITY, CHINA (TAIWAN) 427 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S200 TUNG KENG ENTERPRISE CO., LTD. 510(k) NO: K033240(TRADITIONAL) ATTN: KE-MIN JEN PHONE NO : 886 3 5208829 NO. 58 FU-CHIUN ST. SE DECISION MADE: 18-DEC-03 HSIN-CHU CITY, CHINA (TAIWAN) 427 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501 TYCO HEALTHCARE 510(k) NO: K032827(TRADITIONAL) ATTN: GAIL CHRISTIE PHONE NO : 508-261-8440 15 HAMPSHIRE ST. SE DECISION MADE: 08-DEC-03 MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TYTAN PROFESSIONAL /ECONOMY SERIES SPHYGMOMANOMETER, NO 710/NO 7 TYTAN MEDICAL CORP. 510(k) NO: K033025(TRADITIONAL) ATTN: WILLIAM HSIEH PHONE NO : 886 289 883828 1-3F, NO. 2, 1 LANE, JUANG SE DECISION MADE: 10-DEC-03 SHING RD. SEC. 1, WU GU 248 510(k) STATEMENT TAIPEI HSIEN, R.O.C., CHINA (TAIWAN) 248 DEVICE: ULTICARE DISPOSABLE SYRINGE 3 ML/CC ULTIMED, INC. 510(k) NO: K033794(SPECIAL) ATTN: ELLEN G REDDING PHONE NO : 360-466-1881 188 SUQUAMISH WAY SE DECISION MADE: 30-DEC-03 LACONNER, WA 98257 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERMAQUICK SE BONDING SYSTEM ULTRADENT PRODUCTS, INC. 510(k) NO: K032626(TRADITIONAL) ATTN: PETER ALLRED PHONE NO : 801-572-4200 505 WEST 10200 SOUTH SE DECISION MADE: 03-DEC-03 SOUTH JORDAN, UT 84095 510(k) STATEMENT DEVICE: "LONG LOVE" CONDOM UNIDUS CORP. 510(k) NO: K033541(ABBREVIATED) ATTN: ELI J CARTER PHONE NO : 919-544-4098 1219 LITTLE CREEK RD. SE DECISION MADE: 23-DEC-03 DURHAM, NC 27713 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE UNITED STATES SURGICAL, A DIVISION510(k) NO: K032696(TRADITIONAL) ATTN: CHESTER MCCOY PHONE NO : 203-492-5179 150 GLOVER AVE. SE DECISION MADE: 01-DEC-03 NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GEMINI III HYBRID TX/RX 4 CHANNEL HEAD COIL USA INSTRUMENTS, INC. 510(k) NO: K033235(TRADITIONAL) ATTN: CHRISTIE SHUMAKER PHONE NO : 330-562-1000 1515 DANNER DR. SE DECISION MADE: 17-DEC-03 AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PELVIC ARRAY COIL USA INSTRUMENTS, INC. 510(k) NO: K033753(SPECIAL) ATTN: CHRISTIE SHUMAKER PHONE NO : 330-995-8572 1515 DANNER DR. SE DECISION MADE: 17-DEC-03 AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED DISPOSABLE CUTTERS, STAPLERS AND APPLIERS VANGUARD MEDICAL CONCEPTS, INC. 510(k) NO: K032973(TRADITIONAL) ATTN: MARK ALDANA PHONE NO : 806-787-0756 3706 76TH STREET SE DECISION MADE: 18-DEC-03 LUBBOCK, TX 79423 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMI REPROCESSED MULTIPLE CLIP APPLIERS VANGUARD MEDICAL CONCEPTS, INC. 510(k) NO: K032980(TRADITIONAL) ATTN: MARK ALDANA PHONE NO : 806-787-0756 3706 76TH STREET SE DECISION MADE: 18-DEC-03 LUBBOCK, TX 79423 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VARIAN INTRACAVITARY BRACHYTHERAPY APPLICATORS VARIAN MEDICAL SYSTEMS 510(k) NO: K033371(TRADITIONAL) ATTN: VY TRAN PHONE NO : 650-424-5731 3100 HANSEN WAY SE DECISION MADE: 24-DEC-03 M/S E-110 510(k) SUMMARY AVAILABLE FROM FDA PALO ALTO, CA 94304-1129 DEVICE: ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K033339(TRADITIONAL) ATTN: VY TRAN PHONE NO : 650-424-5731 3100 HANSEN WAY SE DECISION MADE: 30-DEC-03 PALO ALTO, CA 94304-1038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRILOGY RADIOTHERAPY DELIVERY SYSTEM VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K033343(TRADITIONAL) ATTN: VY TRAN PHONE NO : 650-424-5731 3100 HANSEN WAY SE DECISION MADE: 23-DEC-03 PALO ALTO, CA 94304-1038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFESITE HEMODIALYSIS ACCESS SYSTEM, CANNULA EXCHANGE KIT, INSER VASCA, INC. 510(k) NO: K023023(TRADITIONAL) ATTN: NAMA DODDI PHONE NO : 978-863-4400 3 HIGHWOOD DR. SE DECISION MADE: 04-DEC-03 TEWKSBURY, MA 01876 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0 VASCULAR CONTROL SYSTEMS, INC 510(k) NO: K031812(TRADITIONAL) ATTN: AL MEMMOLO PHONE NO : 949-488-8700 32236- E PASEO ADELANTO SE DECISION MADE: 12-DEC-03 SAN JUAN CAPISTRANO, CA 92675 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER VASCULAR SOLUTIONS, INC. 510(k) NO: K032763(TRADITIONAL) ATTN: GREGORY SACHS PHONE NO : 763-656-4210 6464 SYCAMORE COURT NORTH SE DECISION MADE: 19-DEC-03 MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASCULAR SOLUTIONS D-STAT 2 DRY HEMOSTATIC BANDAGE VASCULAR SOLUTIONS, INC. 510(k) NO: K033709(SPECIAL) ATTN: GREGORY W SACHS PHONE NO : 763-656-4210 6464 SYCAMORE COURT SE DECISION MADE: 18-DEC-03 MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERTELINK KOBRA SPINAL FIXATION SYSTEM VERTELINK CORPORATION 510(k) NO: K032102(TRADITIONAL) ATTN: GREG HOLLAND PHONE NO : 949-262-0411 3722 AVE. SAUSALITO SE DECISION MADE: 12-DEC-03 IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GORE BIOABSORBABLE MESH W. L. GORE & ASSOCIATES, INC. 510(k) NO: K033671(TRADITIONAL) ATTN: BRANDON HANSEN PHONE NO : 928-864-3784 3450 WEST KILTIE LN. SE DECISION MADE: 31-DEC-03 FLAGSTAFF, AZ 86002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POTENS + WADA, INC. 510(k) NO: K033137(TRADITIONAL) ATTN: GAIL RODRICK-HIGHBERG PHONE NO : 510-792-1527 35949 NICOLET CT. SE DECISION MADE: 08-DEC-03 FREMONT, CA 94536 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LORENZ STERNAL CLOSURE SYSTEM WALTER LORENZ SURGICAL, INC. 510(k) NO: K033740(SPECIAL) ATTN: KIM REED PHONE NO : 904-741-4400 1520 TRADEPORT DR. SE DECISION MADE: 15-DEC-03 JACKSONVILLE, FL 32218 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: T-TECH DIGITAL, MODEL WL-22XXA SERIES WELL-LIFE HEALTHCARE, INC. 510(k) NO: K033857(SPECIAL) ATTN: JENNY HSIAH PHONE NO : 886 229 282112 6C01, NO.5, SEC.5, HSIN YI RD. SE DECISION MADE: 19-DEC-03 TAIPEI, CHINA (TAIWAN) 106 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WILSON-COOK TRI-TOME SELECT PLUS WILSON-COOK MEDICAL, INC. 510(k) NO: K033203(TRADITIONAL) ATTN: MARGE WALLS-WALKER PHONE NO : 336-744-0157 4900 BETHANIA STATION RD. SE DECISION MADE: 19-DEC-03 WINSTON-SALEM, NC 27105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRACER METRO SMART WIRE GUIDE WILSON-COOK MEDICAL, INC. 510(k) NO: K033754(SPECIAL) ATTN: MARGE WALLS-WALKER PHONE NO : 336-744-0157 4900 BETHANIA STATION RD. SE DECISION MADE: 30-DEC-03 WINSTON-SALEM, NC 27105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TIE-IN TRAPEZIUM WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K033529(SPECIAL) ATTN: KATIE LOGEROT PHONE NO : 901-867-4476 5677 AIRLINE RD. SE DECISION MADE: 03-DEC-03 ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROFEEL POWDER FREE, PLOYMER COATED POLYISOPRENE SURGICAL GLOVES WRP ASIA PACIFIC SDN. BHD. 510(k) NO: K032942(TRADITIONAL) ATTN: TERENCE LIM PHONE NO : 60 3 87061486 LOT 1, JALAN 3, SE DECISION MADE: 17-DEC-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-T3D WU'S TECH CO., LTD. 510(k) NO: K032488(TRADITIONAL) ATTN: JEN KE-MIN PHONE NO : 886 352 08829 NO. 58, FU-CHIUN ST. SE DECISION MADE: 02-DEC-03 HSIN-CHU CITY, CHINA (TAIWAN) ROC 510(k) STATEMENT DEVICE: VPT METER XILAS MEDICAL, INC. 510(k) NO: K030829(TRADITIONAL) ATTN: RUBEN G ZAMORANO PHONE NO : 210-692-1114 12665 SILICON DR. SE DECISION MADE: 05-DEC-03 SAN ANTONIO, TX 78249 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: YA-MAN LASER 21 YA-MAN LTD 510(k) NO: K032944(TRADITIONAL) ATTN: ROBERT T HANDREN PHONE NO : 352-314-8829 5818 PRINCESS CAROLINE PLACE SE DECISION MADE: 19-DEC-03 LEESBURG, FL 34748 510(k) STATEMENT TOTAL 510(k)s THIS PERIOD 288 TOTAL WITH SUMMARIES 234 TOTAL WITH STATEMENTS 54
Updated January 5, 2004
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