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Medical Devices
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April 2006 510(k) Clearances
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-APR-2006 THROUGH 30-APR-2006
DEVICE: ADPER PROMPT, ADPER PROMPT L-POP
3M ESPE AG DENTAL PRODUCTS 510(k) NO: K060684(TRADITIONAL)
ATTN: SABINE KRISCHER PHONE NO : 498 152 7001238
ESPE PLATZ SE DECISION MADE: 24-APR-06
SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE
ABBOTT DIABETES CARE INC. 510(k) NO: K060768(SPECIAL)
ATTN: MARIA E TREJO PHONE NO : 510-749-6384
1360 SOUTH LOOP RD. SE DECISION MADE: 21-APR-06
ALAMEDA, CA 94502-7000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACON BUP ONE STEP BUPRENORPHINE TEST STRIP AND ACRON BUP ONE STE
ACON LABORATORIES, INC. 510(k) NO: K060466(TRADITIONAL)
ATTN: EDWARD TUNG PHONE NO : 858-535-2030
4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 21-APR-06
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KELO-COTE SPRAY
ADVANCED BIO-TECHNOLOGIES, INC. 510(k) NO: K053481(TRADITIONAL)
ATTN: STEVEN CHERNOFF PHONE NO : 425-861-8262
P.O. BOX 3515 SE DECISION MADE: 14-APR-06
REDMOND, WA 98073-3515 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE AMO OPHTHALMIC SURGICAL SYSTEM
ADVANCED MEDICAL OPTICS, INC. 510(k) NO: K060366(ABBREVIATED)
ATTN: TONI ELLIOTT PHONE NO : 614-834-1204
1700 EAST ST. ANDREW PL. SE DECISION MADE: 07-APR-06
MAIL STOP: SA-2J 510(k) SUMMARY AVAILABLE FROM FDA
SANTA ANA, CA 92799
DEVICE: AESCULAP CRANIOFACIAL PLATE AND SCREW
AESCULAP, INC. 510(k) NO: K060492(TRADITIONAL)
ATTN: MATTHEW M HULL PHONE NO : 610-797-9300
3773 CORPORATE PKWY. SE DECISION MADE: 07-APR-06
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMPLATZER NOODLEWIRE GUIDEWIRE
AGA MEDICAL CORP. 510(k) NO: K053187(TRADITIONAL)
ATTN: PATRICIA A LAFORET PHONE NO : 763-513-9227
682 MENDELSSOHN AVE. SE DECISION MADE: 27-APR-06
GOLDEN VALLEY, MN 55427 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZ-OX PLUS
AIR LIQUIDE HEALTHCARE AMERICA 510(k) NO: K053117(TRADITIONAL)
ATTN: ANGIE BEYER PHONE NO : 713-624-8268
2700 POST OAK BLVD. SUITE 1800 SE DECISION MADE: 10-APR-06
HOUSTON, TX 77056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BREATHSCAN, BREATH AND BREATH CHECK ALCOHOL DETECTORS
AKERS BIOSCIENCES, INC. 510(k) NO: K060761(TRADITIONAL)
ATTN: BARBARA A BAGBY PHONE NO : 856-848-8698
201 GROVE RD. SE DECISION MADE: 28-APR-06
THOROFARE, NJ 08086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FDS INTIMATE AND INTIMATE WARMING LUBRICANT
ALBERTO-CULVER USA, INC. 510(k) NO: K060145(TRADITIONAL)
ATTN: RICK MAIN PHONE NO : 708-450-3153
2525 WEST ARMITAGE AVE. SE DECISION MADE: 14-APR-06
MELROSE PARK, IL 60148 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VANGUARD REPROCESSED COMPRESSION GARMENTS (HILL-ROM)
ALLIANCE MEDICAL, INC. 510(k) NO: K051438(TRADITIONAL)
ATTN: MOIRA BARTON PHONE NO : 480-763-5350
10232 SOUTH 51 ST. SE DECISION MADE: 04-APR-06
PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUROPROBES
ALPHA OMEGA ENGINEERING, LTD. 510(k) NO: K052527(TRADITIONAL)
ATTN: SHLOMO PUNDAK PHONE NO : 972 4 6563327
HA'AVODA ST., P.O. BOX 810 SE DECISION MADE: 12-APR-06
NAZARETH ILLIT, ISRAEL 17105 510(k) STATEMENT
DEVICE: COOLGARD 3000
ALSIUS CORP. 510(k) NO: K060308(TRADITIONAL)
ATTN: KENNETH A COLLINS PHONE NO : 949-453-0150
15770 LAGUNA CANYON, SUITE 150 SE DECISION MADE: 26-APR-06
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROTATING GAMMA SYSTEM. GAMMA ART-6000
AMERICAN RADIOSURGERY, INC. 510(k) NO: K060314(SPECIAL)
ATTN: DAN OLIVIER PHONE NO : 858-675-8200
16787 BERNARDO CENTER DRIVE SE DECISION MADE: 06-APR-06
SUITE A-1 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92128
DEVICE: FLO-RITE, MODEL 478-1; FLO-RITE II, MODEL 478-1; SIMPULSE II, MO
AMERIFLO CORP. 510(k) NO: K060382(SPECIAL)
ATTN: MATTHEW THIE PHONE NO : 317-844-2019
478 GRADLE DR. SE DECISION MADE: 19-APR-06
CARMEL, IN 46032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M
ANALYTICAL INDUSTRIES, INC. 510(k) NO: K053407(TRADITIONAL)
ATTN: PATRICK J PRINDIBLE PHONE NO : 909-392-6900
2855 METROPOLITAN PL. SE DECISION MADE: 05-APR-06
POMONA, CA 91767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANGIODYNAMIC, INC. MORPHEUS CT PICC AND PROCEDURE KIT
ANGIODYNAMICS, INC. 510(k) NO: K060887(SPECIAL)
ATTN: TERI JUCKETT PHONE NO : 518-798-1215
603 QUEENSBURY AVE. SE DECISION MADE: 28-APR-06
QUEENSBURY, NY 12804 510(k) STATEMENT
DEVICE: GELPORT BLUNT TIP TROCAR SYSTEM
APPLIED MEDICAL RESOURCES CORP. 510(k) NO: K060629(TRADITIONAL)
ATTN: CHERYL BLAKE PHONE NO : 949-713-8000
22872 AVENIDA EMPRESA SE DECISION MADE: 07-APR-06
RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SEEKER/SPARK ULTRASOUND SYSTEM
ARDENT SOUND, INC. 510(k) NO: K060800(TRADITIONAL)
ATTN: PAUL JAEGER PHONE NO : 480-649-1806
33 SOUTH SYCAMORE ST. SE DECISION MADE: 07-APR-06
MESA, AZ 85202 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850
ARIZANT HEALTHCARE INC. 510(k) NO: K060865(SPECIAL)
ATTN: DAVID WESTLIN PHONE NO : 952-947-1277
10393 WEST 70TH ST. SE DECISION MADE: 24-APR-06
EDEN PRAIRIE, MN 55344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES
ARROW INTL., INC. 510(k) NO: K060309(SPECIAL)
ATTN: KAREN PROVENCHER PHONE NO : 617-389-6400
9 PLYMOUTH ST. SE DECISION MADE: 06-APR-06
EVERETT, MA 02149 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHREX ARTHOERESIS IMPLANT
ARTHREX, INC. 510(k) NO: K053543(TRADITIONAL)
ATTN: ANN WATERHOUSE PHONE NO : 239-643-5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 03-APR-06
NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHROCARE WANDS
ARTHROCARE CORP. 510(k) NO: K060823(SPECIAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-736-0224
680 VAQUEROS AVE. SE DECISION MADE: 10-APR-06
SUNNYVALE, CA 94085-3523 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING
BARD ACCESS SYSTEMS, INC. 510(k) NO: K053589(TRADITIONAL)
ATTN: MICHAELA RIVKOWICH PHONE NO : 801-595-0700
5425 WEST AMELIA EARNHART DR. SE DECISION MADE: 13-APR-06
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHALON PI POWDER-FREE SYNTHETIC POLYISOPRENE/POLYCHLOROPRENE
BARRIERMED, INC. 510(k) NO: K060733(TRADITIONAL)
ATTN: VICTOR RAGUCCI PHONE NO : 407-771-4424
155 TECHNOLOGY PARK SE DECISION MADE: 24-APR-06
LAKE MARY, FL 32746 510(k) STATEMENT
DEVICE: BARRX HALO COAGULATION SYSTEM, BARRX HALO COAGULATION GENERATOR,
BARRX MEDICAL, INCORPORATED 510(k) NO: K060169(TRADITIONAL)
ATTN: VIORICA FILIMON PHONE NO : 408-328-7302
540 OAKMEAD PARKWAY SE DECISION MADE: 21-APR-06
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; ASCENSIA MICRO
BAYER HEALTHCARE 510(k) NO: K060470(TRADITIONAL)
ATTN: ROGER SONNEMBURG PHONE NO : 574-262-7152
430 SOUTH BEIGER STREET SE DECISION MADE: 12-APR-06
MISHAWAKA, IN 46544 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRI-STAT ACID PHOSPHATASE REAGENT
BECKMAN COULTER, INC. 510(k) NO: K053612(TRADITIONAL)
ATTN: ERI HIRUMI PHONE NO : 714-961-4389
200 SOUTH KRAEMER BLVD. W-110 SE DECISION MADE: 26-APR-06
BREA, CA 92822 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208
BECKMAN COULTER, INC. 510(k) NO: K060774(SPECIAL)
ATTN: CAROLYN ANDERSON PHONE NO : 952-368-7869
1000 LAKE HAZELTINE DR. SE DECISION MADE: 21-APR-06
CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNCHRON SYSTEMS CREATININE (CREA) REAGENT
BECKMAN COULTER, INC. 510(k) NO: K060935(SPECIAL)
ATTN: ANNETTE HELLIE PHONE NO : 714-993-8767
200 SOUTH KRAEMER BLVD. W-110 SE DECISION MADE: 28-APR-06
BREA, CA 92822 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN-0.125-8
BECTON DICKINSON & CO. 510(k) NO: K060217(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287
7 LOVETON CIR. SE DECISION MADE: 12-APR-06
SPARKS, MD 21152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -NITROFURANTOIN (GN) 8-
BECTON DICKINSON & CO. 510(k) NO: K060447(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287
7 LOVETON CIR. SE DECISION MADE: 26-APR-06
SPARKS, MD 21152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOXITIN - 0.5-64 UG
BECTON, DICKINSON & CO. 510(k) NO: K060257(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287
7 LOVETON CIR. SE DECISION MADE: 14-APR-06
SPARKS, MD 21152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) , CEFTR
BECTON, DICKINSON & CO. 510(k) NO: K060444(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287
7 LOVETON CIR. SE DECISION MADE: 12-APR-06
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PICSI SPERM SELECTION DEVICE
BIOCOAT, INC. 510(k) NO: K052457(TRADITIONAL)
ATTN: JAMES B JOHNSTON PHONE NO : 215-572-8977
455 PENNSYLVANIA AVE. SE DECISION MADE: 13-APR-06
FORT WASHINGTON, PA 19034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT
BIOFORM MEDICAL, INC. 510(k) NO: K060815(SPECIAL)
ATTN: JAMES S MILLER PHONE NO : 650-286-4040
1875 SOUTH GRANT ST.,SUITE 11O SE DECISION MADE: 18-APR-06
SAN MATEO, CA 94402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POROUS TITANIUM ACETABULAR SHELLS
BIOMET MANUFACTURING CORP. 510(k) NO: K052996(TRADITIONAL)
ATTN: ALLISON KOSKEY PHONE NO : 574-372-1644
56 EAST BELL DRIVE SE DECISION MADE: 28-APR-06
PO BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: SCOUTPRO 8F, MODELS 342 262; HEMOSTATIC VALVE, MODELS 345 968; "
BIOTRONIK, INC. 510(k) NO: K060655(SPECIAL)
ATTN: JON BRUMBAUGH PHONE NO : 888-345-0374
6024 JEAN RD. SE DECISION MADE: 04-APR-06
LAKE OSWEGO, OR 97035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCOUTPRO 7F CORONARY SINUS LEAD DELIVERY SYSTEM
BIOTRONIK, INC. 510(k) NO: K060807(SPECIAL)
ATTN: JON BRUMBAUGH PHONE NO : 888-345-0374
6024 JEAN RD. SE DECISION MADE: 24-APR-06
LAKE OSWEGO, OR 97035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FILTERWIRE EZ (2.25 MM - 3.5 MM) EMBOLIC PROTECTION SYSTEM, MODE
BOSTON SCIENTIFIC CORP. 510(k) NO: K051984(TRADITIONAL)
ATTN: DEBBIE MCINTIRE PHONE NO : 650-623-1600
2011 STIERLIN CT. SE DECISION MADE: 10-APR-06
MOUNTAIN VIEW, CA 94043-4655 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONICATH ULTRA IMAGING CATHETER, 3.2F,20MHZ MODELS 37410/456221/
BOSTON SCIENTIFIC CORP. 510(k) NO: K060947(SPECIAL)
ATTN: ROBERT Z PHILLIPS PHONE NO : 510-624-2307
47900 BAYSIDE PARKWAY SE DECISION MADE: 19-APR-06
FREMONT, CA 94538-6515 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYMMETRY BALLOON DILATATION CATHETER
BOSTON SCIENTIFIC CORPORATION 510(k) NO: K060959(TRADITIONAL)
ATTN: ANGELA BYLAND PHONE NO : 763-494-2887
TWO SCIMED PLACE SE DECISION MADE: 12-APR-06
MAPLE GROVE, MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOSTON SCIENTIFIC TALON BALLOON DILATATION CATHETER
BOSTON SCIENTIFIC CORPORATION 510(k) NO: K060960(TRADITIONAL)
ATTN: SARA L COON PHONE NO : 763-494-7983
TWO SCIMED PLACE SE DECISION MADE: 12-APR-06
MAPLE GROVE, MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE, BLACK COL
BRIGHTWAY HOLDINGS SDN. BHD. 510(k) NO: K060658(TRADITIONAL)
ATTN: G. BASKARAN PHONE NO : 603 334 31007
LOT 1559, JALAN ISTIMEWA, SE DECISION MADE: 10-APR-06
BATU BELAH 510(k) STATEMENT
KLANG, SELANGOR, MALAYSIA 42100
DEVICE: BUSSE HOSPITAL DISPOSABLES NEEDLE STICK BLOCK/CUBE
BUSSE HOSPITAL DISPOSABLES, INC. 510(k) NO: K052843(TRADITIONAL)
ATTN: MUHAMAD ANSARI PHONE NO : 631-435-4711
75 ARKAY DRIVE SE DECISION MADE: 17-APR-06
P.O. BOX 11067 510(k) SUMMARY AVAILABLE FROM FDA
HAUPPAUGE, NY 11788
DEVICE: ENDOGATOR ENDOSCOPY IRRIGATION PUMP, MODEL EGP-100
BYRNE MEDICAL, INC. 510(k) NO: K060962(TRADITIONAL)
ATTN: J. HARVEY KNAUSS PHONE NO : 832-285-9423
11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 19-APR-06
HOUSTON, TX 77071 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BARD COLLAMEND IMPLANT, MODELS 1175101, 1175102, 1175103, 117510
C.R. BARD, INC. 510(k) NO: K052322(TRADITIONAL)
ATTN: ROBIN DRAGO PHONE NO : 401-463-7000
100 SOCKANOSSETT CROSSROAD SE DECISION MADE: 10-APR-06
P.O. BOX 8500 510(k) SUMMARY AVAILABLE FROM FDA
CRANSTON, RI 02920
DEVICE: SHERLOCK TIP LOCATION SYSTEM (TLS)
C.R. BARD, INC. 510(k) NO: K060341(TRADITIONAL)
ATTN: LYNN M KIRCHOFF PHONE NO : 801-595-0700
5425 WEST AMELIA EARHART DR. SE DECISION MADE: 14-APR-06
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PALLADIUM-103 SEED IMPLANT KITS -MULTIPLE
C.R. BARD, INC. 510(k) NO: K060636(TRADITIONAL)
ATTN: JULIE J BASSETT PHONE NO : 678-342-4921
13183 HARLAND DR. NE SE DECISION MADE: 19-APR-06
COVINGTON, GA 30014-6421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PMP4 BP PRO BLOOD PRESSURE MONITOR
CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K060703(SPECIAL)
ATTN: ALEX GONOROVSKY PHONE NO : 972 8 9484044
2 PEKERIS ST. SE DECISION MADE: 04-APR-06
REHOVOT, ISRAEL 76100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATRIA 3100, ATRIA 6100
CARDIAC SCIENCE CORPORATION 510(k) NO: K060167(ABBREVIATED)
ATTN: CHERYL SHEA PHONE NO : 425-402-2255
3303 MONTE VILLA PKWY. SE DECISION MADE: 19-APR-06
BOTHELL, WA 98021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODE
CARDIONET, INC 510(k) NO: K053263(ABBREVIATED)
ATTN: JACK GAIKWAD PHONE NO : 619-243-7500
1010 2ND AVE., SUITE 700 SE DECISION MADE: 25-APR-06
SAN DIEGO, CA 92101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHASEAL - CLOSED SYSTEM FOR THE PREPARATION AND ADMINISTRATION O
CARMEL PHARMA AB. 510(k) NO: K060866(SPECIAL)
ATTN: KJELL ANDREASSON PHONE NO : 46 31 7030400
AMINOGATAN 30, MOLNDAL SE DECISION MADE: 28-APR-06
BOX 5352 510(k) SUMMARY AVAILABLE FROM FDA
GOTEBORG, SWEDEN SE 402 28
DEVICE: TULIP DISPOSABLE CANNULAS
CELL BIO-SYSTEMS, INC. 510(k) NO: K060089(TRADITIONAL)
ATTN: CHRISTINE EMANUEL PHONE NO : 805-963-4312
1205 DE LA VINA STREET SE DECISION MADE: 27-APR-06
SANTA BARBARA, CA 93101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EPICERAM
CERAGENIX CORPORATION 510(k) NO: K052643(TRADITIONAL)
ATTN: CARL GENBERG PHONE NO : 303-478-8965
1444 WAZEE STREET SE DECISION MADE: 11-APR-06
DENVER, CO 80202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERS
CETRO AMERICA 510(k) NO: K050826(TRADITIONAL)
ATTN: MAYA CIANCIOLO PHONE NO : 203-248-0500
925 SHERMAN AVENUE SE DECISION MADE: 10-APR-06
HAMDEN, CT 06514 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ENDOTINE RIBBON
COAPT SYSTEMS, INC. 510(k) NO: K060828(SPECIAL)
ATTN: LINDA RUEDY PHONE NO : 650-461-7600
1820 EMBARCADERO RD. SE DECISION MADE: 19-APR-06
PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHYSIOGLOVE ES
COMMWELL LTD. 510(k) NO: K050674(TRADITIONAL)
ATTN: JONATHAN S KAHN PHONE NO : 202-637-5600
555 THIRTEENTH ST., NW SE DECISION MADE: 25-APR-06
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOGLOBIN ALC CONTROL
COMPASS BIOSCIENCE 510(k) NO: K060570(TRADITIONAL)
ATTN: CARTER GRANDJEAN PHONE NO : 626-359-9645
1850 EVERGREEN ST. SE DECISION MADE: 13-APR-06
DUARTE, CA 91010-2906 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENTAKE STANDARD AND SAFETY PEG SYSTEM
CONMED CORP. 510(k) NO: K061021(TRADITIONAL)
ATTN: BETH A ZIS PHONE NO : 978-964-4251
129 CONCORD ROAD SE DECISION MADE: 28-APR-06
BUILDING 3 510(k) SUMMARY AVAILABLE FROM FDA
BILLERICA, MA 01821 THIRD PARTY REVIEW
DEVICE: NURSE ASSISTANT 1.7 O.R. CONTROL SYSTEM
CONMED INTEGRATED SYSTEMS (CMIS) 510(k) NO: K060717(SPECIAL)
ATTN: C. JEFF LIPPS PHONE NO : 503-614-1106
1815 NW 169TH PLACE SE DECISION MADE: 25-APR-06
SUITE 4020 510(k) SUMMARY AVAILABLE FROM FDA
BEAVERTON, OR 97006
DEVICE: HI-FI ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR
CONMED LINVATEC 510(k) NO: K060714(SPECIAL)
ATTN: ELIZABETH PAUL PHONE NO : 727-399-5234
11311 CONCEPT BOULEVARD SE DECISION MADE: 06-APR-06
LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,
CORDIS CORP. 510(k) NO: K060877(SPECIAL)
ATTN: KAREN WILK PHONE NO : 908-412-7257
7 POWDER HORN DR. SE DECISION MADE: 27-APR-06
WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED
CORDIS EUROPA, N.V. 510(k) NO: K060302(TRADITIONAL)
ATTN: HARM HOVINGA PHONE NO : 31 505 022479
OOSTEINDE 8 SE DECISION MADE: 11-APR-06
RODEN, DRENTHE, NETHERLANDS NL-930510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LESIONPOINT RF CANNULA
COSMAN MEDICAL, INC. 510(k) NO: K053415(TRADITIONAL)
ATTN: MICHAEL ARNOLD PHONE NO : 781-272-6561
76 CAMBRIDGE ST. SE DECISION MADE: 25-APR-06
BURLINGTON, MA 01803-4140 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLLAGRAN-COLLAGEN WOUND DRESSING, COLLAGRANAG-COLLAGEN W/SILVER
COVALON TECHNOLOGIES LTD. 510(k) NO: K060804(SPECIAL)
ATTN: JACQUES LEMMETTI PHONE NO : 704-243-3059
2033 IVERSON LANES SE DECISION MADE: 18-APR-06
WAXHAW, NC 28173 510(k) STATEMENT
DEVICE: SPRAYGENIX CRYO ABLATION SYSTEM
CRYMED TECHNOLOGIES, INC. 510(k) NO: K060555(TRADITIONAL)
ATTN: TIM ASKEW PHONE NO : 443-921-8053
3225 ELLERSLIE AVE. SE DECISION MADE: 21-APR-06
THIRD FLOOR, STE. B311 510(k) SUMMARY AVAILABLE FROM FDA
BALTIMORE, MD 21218
DEVICE: GREEN LOVE MALE CONTRACEPTIVE (CONDOM)
CUPID CONDOM, LTD. 510(k) NO: K051842(ABBREVIATED)
ATTN: K.K. GOYAL PHONE NO : 912 551 230280
A-68, MIDC SINNAR, (MALEGAON) SE DECISION MADE: 14-APR-06
NASHIK, MAHARASHTRA, INDIA 422 113510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GELITA-SPON ABSORBABLE GELATIN SPONGE, USP
CURAMEDICAL, BV 510(k) NO: K060878(SPECIAL)
ATTN: WILLIAM GREENROSE PHONE NO : 603-369-3550
220 RIVER ROAD SE DECISION MADE: 13-APR-06
CLAREMONT, NH 03743 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA CTNI FLEX FLEX REAGENT CARTRIDGE, CALIBRATOR AND
DADE BEHRING, INC. 510(k) NO: K053577(TRADITIONAL)
ATTN: GEORGE M PLUMMER PHONE NO : 302-631-9798
GLASGOW BUSINESS COMMUNITY; SE DECISION MADE: 14-APR-06
BLDG. 500 MAIL BOX 514 510(k) SUMMARY AVAILABLE FROM FDA
P.O. BOX 6101, NEWARK, DE 19714-6101
DEVICE: EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT
DADE BEHRING, INC. 510(k) NO: K060385(TRADITIONAL)
ATTN: YUK-TING LEWIS PHONE NO : 302-631-7626
P.O. BOX 6101 SE DECISION MADE: 06-APR-06
NEWARK, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK
DADE BEHRING, INC. 510(k) NO: K060548(TRADITIONAL)
ATTN: PAMELA A JURGA PHONE NO : 302-631-8891
GLASGOW BUSINESS COMMUNITY SE DECISION MADE: 06-APR-06
BLDG 500, MS 514 P.O.BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: DIMENSION TBI FLEX AND DBI FLEX REAGENT CARTRIDGES AND TBI/DBI C
DADE BEHRING, INC. 510(k) NO: K060628(SPECIAL)
ATTN: GEORGE M PLUMMER PHONE NO : 302-631-9798
GLASGOW BUSINESS COMMUNITY SE DECISION MADE: 06-APR-06
BLDG 500, MS 514 P.O.BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: DSI PINS AND WIRES
DELTA SURGICAL INSTRUMENTS, INC. 510(k) NO: K060654(TRADITIONAL)
ATTN: DANDENIA ZABAT PHONE NO : 845-928-3760
95 SCHUNNEMUNK RD. SE DECISION MADE: 28-APR-06
HIGHLAND MILLS, NY 10930 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10
DENKA SEIKEN CO., LTD. 510(k) NO: K060359(ABBREVIATED)
ATTN: TOSHIMI MATSUNAGA PHONE NO : 812 504 27222
1-2-2, MINAMI HON CHO SE DECISION MADE: 14-APR-06
GOSEN-SHI, NIIGATA, JAPAN 959-1695510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DR DISPOSABLE PROPHY ANGLE MODEL H310
DENTAL RESOURCES 510(k) NO: K060377(TRADITIONAL)
ATTN: BRYAN NICHOLS PHONE NO : 320-963-6267
400 CONGRESS ST. W. SE DECISION MADE: 26-APR-06
MAPLE LAKE, MN 55358 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM
DENTAMERICA 510(k) NO: K060640(TRADITIONAL)
ATTN: ERIC HUANG PHONE NO : 626-912-1388
18320 BEDFORD CIRCLE SE DECISION MADE: 24-APR-06
P.O. BOX 3200 510(k) SUMMARY AVAILABLE FROM FDA
INDUSTRY, CA 91744
DEVICE: IN-OVATION C
DENTSPLY INTERNATIONAL 510(k) NO: K060837(SPECIAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511
221 WEST PHILADELPHIA ST. SE DECISION MADE: 10-APR-06
SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: ACCLAIM TOTAL ELBOW SYSTEM
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K060696(SPECIAL)
ATTN: NATALIE S HECK PHONE NO : 574-372-7469
700 ORTHOPAEDIC DR. SE DECISION MADE: 14-APR-06
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: CRP-ADVANCE ASSAY, MODELS 250-20, 250-25
DIAGNOSTIC CHEMICALS LTD. 510(k) NO: K060139(TRADITIONAL)
ATTN: PENNY WHITE PHONE NO : 902 566 1396
16 MCCARVILLE ST. SE DECISION MADE: 28-APR-06
CHARLOTTETOWN, PE, CANADA C1E 2A6 510(k) STATEMENT
DEVICE: CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250
DIAGNOSTIC CHEMICALS LTD. 510(k) NO: K060140(TRADITIONAL)
ATTN: PENNY WHITE PHONE NO : 902 566 1396
16 MCCARVILLE ST. SE DECISION MADE: 24-APR-06
CHARLOTTETOWN, PE, CANADA C1E 2A6 510(k) STATEMENT
DEVICE: IMMULITE 2500 VITAMIN B12 MODEL L5KVB2-200 TEST,L5KVB6-600 TEST,
DIAGNOSTIC PRODUCTS CORPORATION 510(k) NO: K060929(SPECIAL)
ATTN: DEBORAH L MORRIS PHONE NO : 310-645-8200
5210 PACIFIC CONCOURSE DR. SE DECISION MADE: 28-APR-06
LOS ANGELES, CA 90045-6900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DICK'S FORMALWEAR MALE LATEX CONDOM
DICK'S FORMALWEAR INC. 510(k) NO: K050913(TRADITIONAL)
ATTN: CURT STRENK PHONE NO : 602-317-6917
3507 W. BETHANY HOME ROAD SE DECISION MADE: 04-APR-06
PHOENIX, AZ 85019 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFINITY DELTA AND KAPPA SERIES MONITORS WITH VF6 MODIFICATIONS
DRAEGER MEDICAL SYSTEMS, INC. 510(k) NO: K060039(SPECIAL)
ATTN: KAREN IORIO PHONE NO : 978-907-7500
16 ELECTRONICS AVE. SE DECISION MADE: 12-APR-06
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM
DRAEGER MEDICAL SYSTEMS, INC. 510(k) NO: K060223(SPECIAL)
ATTN: KAREN A IORIO PHONE NO : 978-907-7500
16 ELECTRONICS AVE. SE DECISION MADE: 12-APR-06
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO INFINITY EXPLORER
DRAEGER MEDICAL SYSTEMS, INC. 510(k) NO: K060254(SPECIAL)
ATTN: KAREN A IORIO PHONE NO : 978-564-8364
16 ELECTRONICS AVE. SE DECISION MADE: 04-APR-06
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECP HEALTH SYSTEM, MODEL 2005
ECP HEALTH INC. 510(k) NO: K052611(TRADITIONAL)
ATTN: SHAMON HUANG PHONE NO : 817-253-2891
8416 PRAIRIE ROSE LANE SE DECISION MADE: 26-APR-06
FORT WORTH, TX 76123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRESEP OLIGON OXIMETRY CATHETERS
EDWARDS LIFESCIENCES, LLC. 510(k) NO: K060093(TRADITIONAL)
ATTN: JASON SMITH PHONE NO : 949-250-2500
ONE EDWARDS WAY SE DECISION MADE: 28-APR-06
IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EW200 SYSTEM (OXYGEN SATURATION MONITORING SYSTEM) AND PRESEP OX
EDWARDS LIFESCIENCES, LLC. 510(k) NO: K060660(TRADITIONAL)
ATTN: PAULA A TORRIANNI PHONE NO : 949-250-2418
ONE EDWARDS WAY SE DECISION MADE: 25-APR-06
IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MONOCHROME LCD MONITOR, RADIFORCE MODEL GS310
EIZO NANAO CORPORATION 510(k) NO: K060845(SPECIAL)
ATTN: HIROAKI HASHIMOTO PHONE NO : 81 76 2742468
153 SHIMOKASHIWANO-CHO SE DECISION MADE: 25-APR-06
HAKUSAN, ISHIKAWA-KEN, JAPAN 924-8510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVA
ELCAM MEDICAL A.C.A.L. 510(k) NO: K060231(SPECIAL)
ATTN: TALI HAZAN PHONE NO : 972 4 6988875
KIBBUTZ BAR-AM SE DECISION MADE: 13-APR-06
D.N. MEROM HAGALIL, ISRAEL 13860 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HUMAPEN MEMOIR
ELI LILLY AND COMPANY 510(k) NO: K053563(TRADITIONAL)
ATTN: LEEANN CHAMBERS PHONE NO : 317-277-1813
LILLY CORPORATE CENTER SE DECISION MADE: 07-APR-06
INDIANAPOLIS, IN 46285 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYST
ENDIUS, INC. 510(k) NO: K060683(TRADITIONAL)
ATTN: CHRISTINE KUNTZ-NASSIF PHONE NO : 508-643-0983
23 WEST BACON ST. SE DECISION MADE: 18-APR-06
PLAINVILLE, MA 02762 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM
ENDIUS, INC. 510(k) NO: K060990(TRADITIONAL)
ATTN: CHRISTINE KUNTZ-NASSIF PHONE NO : 508-643-0983
23 WEST BACON ST. SE DECISION MADE: 26-APR-06
PLAINVILLE, MA 02762 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ERGOSELECT 100 K/P, ERGOSELECT 200 K/P
ERGOLINE GMBH 510(k) NO: K053078(TRADITIONAL)
ATTN: HAIKO BELL PHONE NO : +49 743 198949
LINDENSTR. 6 SE DECISION MADE: 27-APR-06
BITZ, B-W, GERMANY 72475 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ANTHOGYR CONTRA ANGLES AND HANDPIECES
EST. ANTHOGYR 510(k) NO: K060317(TRADITIONAL)
ATTN: ERIC GENEVE PHONE NO : 33 045 0580237
164 RUE DES TROIS LACS SE DECISION MADE: 28-APR-06
SALLANCHES, FRANCE 74700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HARMONIC SCALPEL BLADES AND SHEARS
ETHICON ENDO-SURGERY, INC. 510(k) NO: K060245(TRADITIONAL)
ATTN: ELIZABETH MILLER PHONE NO : 513-337-7146
4545 CREEK RD. SE DECISION MADE: 07-APR-06
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHETIC VINYL PATIENT EXAMINATION GLOVE-POWDER FREE
EVER LIGHT PLASTIC PRODUCTS CO., L510(k) NO: K060778(TRADITIONAL)
ATTN: KATHY LIU PHONE NO : 909-591-7888
3973 SCHAEFER AVE SE DECISION MADE: 28-APR-06
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XLTEK EMU40 EEG HEADBOX, MODEL PK1072
EXCEL TECH. LTD. 510(k) NO: K053386(TRADITIONAL)
ATTN: NICOLE LANDREVILLE PHONE NO : 905 829 5300
2568 BRISTOL CIRCLE SE DECISION MADE: 21-APR-06
OAKVILLE, ONTARIO, CANADA L6H 5S1510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUTE CARE FACE MASK, MODEL RT040
FISHER & PAYKEL HEALTHCARE, LTD. 510(k) NO: K060044(TRADITIONAL)
ATTN: BRETT WHISTON PHONE NO : 649 574 0100
P.O BOX 14-348 SE DECISION MADE: 06-APR-06
PANMURE, AUCKLAND, NEW ZEALAND 170510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERA
GALIL MEDICAL LTD. 510(k) NO: K060390(SPECIAL)
ATTN: JONATHAN S KAHN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, N.W. SE DECISION MADE: 27-APR-06
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE
GAMBRO RENAL PRODUCTS 510(k) NO: K060195(TRADITIONAL)
ATTN: THOMAS B DOWELL PHONE NO : 303-231-4094
10810 WEST COLLINS AVE. SE DECISION MADE: 24-APR-06
LAKEWOOD, CO 80215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRAM MODULE
GE HEALTHCARE 510(k) NO: K053121(SPECIAL)
ATTN: JOEL KENT PHONE NO : 781-449-8685
86 PILGRIM ROAD SE DECISION MADE: 05-APR-06
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVANCE VESSEL ANALYSIS II
GE HEALTHCARE 510(k) NO: K060779(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
3000 N. GRANDVIEW BLVD. SE DECISION MADE: 05-APR-06
WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STA
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K053356(TRADITIONAL)
ATTN: RONALD N BLASKI PHONE NO : 414-362-2348
8200 WEST TOWER AVE. SE DECISION MADE: 19-APR-06
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MACTRODE 3
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K060661(SPECIAL)
ATTN: KAREN RUSSELL PHONE NO : 414-362-3166
8200 WEST TOWER AVE. SE DECISION MADE: 07-APR-06
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE LIGHTSPEED XTRA CT SCANNER SYSTEM
GE MEDICAL SYSTEMS, LLC 510(k) NO: K060052(TRADITIONAL)
ATTN: GLEN E SABIN PHONE NO : 262-312-7703
3000 N. GRANDVIEW BLVD. SE DECISION MADE: 19-APR-06
WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: LOW BACK PAIN RELIEF SYSTEM /MODELS GM310PP,GM320PP,GM321PP, AND
GEMORE TECHNOLOGY CO., LTD. 510(k) NO: K060222(TRADITIONAL)
ATTN: BODEN S.P. LAI PHONE NO : 886 288 091799
11 FL, NO. 29-5, SEC. 2 SE DECISION MADE: 28-APR-06
CHUNG CHENG E. RD. 510(k) SUMMARY AVAILABLE FROM FDA
TAN SHUI, TAIPEI HSIEN, CHINA (TAIWAN) 251
DEVICE: GUAVA EZCD4 SYSTEM
GUAVA TECHNOLOGIES, INC. 510(k) NO: K053497(TRADITIONAL)
ATTN: LAWRENCE F BRUDER PHONE NO : 510-576-1400
25801 INDUSTRIAL BLVD. SE DECISION MADE: 14-APR-06
HAYWARD, CA 94545 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNILINK .035 BILIARY STENT SYSTEM
GUIDANT CORPORATION 510(k) NO: K053459(TRADITIONAL)
ATTN: SYLVIA HERNANDEZ PHONE NO : 951-914-4412
26531 YNEZ ROAD SE DECISION MADE: 12-APR-06
TEMECULA, CA 92591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM
GYNOVA, LLC 510(k) NO: K052420(TRADITIONAL)
ATTN: DON GUINAN PHONE NO : 860-647-8480
698 MIDDLE TNPK E SE DECISION MADE: 06-APR-06
MANCHESTER, CT 06040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTIDIRECTIONAL THREADED PEG
HAND INNOVATIONS, LLC. 510(k) NO: K060864(SPECIAL)
ATTN: NATALIE S HECK PHONE NO : 305-270-6899
8905 SW 87TH AVENUE SE DECISION MADE: 28-APR-06
SUITE 220 510(k) SUMMARY AVAILABLE FROM FDA
MIAMI, FL 33176
DEVICE: CONSENSUS ACETABULAR SHELL SYSTEM
HAYES MEDICAL, INC. 510(k) NO: K060635(SPECIAL)
ATTN: LUKE ROSE PHONE NO : 916-355-7156
1115 WINDFIELD WAY, SUITE 100 SE DECISION MADE: 28-APR-06
EL DORADO HILLS, CA 95762-9623 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168FV
HEALTH & LIFE CO., LTD. 510(k) NO: K060729(SPECIAL)
ATTN: ALEX KOU PHONE NO : 886 282 271300
9F, NO.186, JIAN YI ROAD SE DECISION MADE: 12-APR-06
CHUNG HO CITY, TAIPEI, CHINA (TAIW510(k) STATEMENT
DEVICE: HL888SF
HEALTH & LIFE CO., LTD. 510(k) NO: K060835(SPECIAL)
ATTN: ALEX KOU PHONE NO : 886 282 271300
9F, NO.186, JIAN YI ROAD SE DECISION MADE: 21-APR-06
CHUNG HO CITY, TAIPEI, CHINA (TAIW510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO HEALTH BUDDY APPLIANCE
HEALTH HERO NETWORK, INC. 510(k) NO: K060843(SPECIAL)
ATTN: ROBIN BUSH PHONE NO : 510-796-2991
2000 SEAPORT BLVD, SUITE 400 SE DECISION MADE: 20-APR-06
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEALTHSTATS BPRO AMBULATORY BLOOD PRESSURE MONITORING SYSTEM
HEALTHSTATS INTERNATIONAL PTE. LTD510(k) NO: K060315(TRADITIONAL)
ATTN: STEPHEN GORSKI PHONE NO : 262-594-2114
S65 W35739 PIPER ROAD SE DECISION MADE: 07-APR-06
EAGLE, WI 53119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROBEAT WITH MGCS
HITACHI, LTD. 510(k) NO: K060834(SPECIAL)
ATTN: JONATHAN S KAHN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, NW SE DECISION MADE: 19-APR-06
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IVA (MXA II SOFTWARE OPTION)
HOLOGIC, INC. 510(k) NO: K060111(TRADITIONAL)
ATTN: JEANETTE SCHIER-PUGSLEY PHONE NO : 781-999-7406
35 CROSBY DR. SE DECISION MADE: 24-APR-06
BEDFORD, MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
HONGYE PLASTIC PRODUCTS CO., LTD. 510(k) NO: K060147(TRADITIONAL)
ATTN: MICKY LIN PHONE NO : 909-591-7888
3973 SCHAFER AVE. SE DECISION MADE: 28-APR-06
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087; 6
HOSPIRA, INC. 510(k) NO: K060806(SPECIAL)
ATTN: PATRICIA MELERSKI PHONE NO : 224-212-4880
275 N. FIELD DR., BLDG. H-2 SE DECISION MADE: 21-APR-06
DEPT. 389 510(k) SUMMARY AVAILABLE FROM FDA
LAKE FOREST, IL 60045
DEVICE: VARIAX LOCKING PLATE SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K060613(TRADITIONAL)
ATTN: VIVIAN KELLY PHONE NO : 201-831-5581
325 CORPORATE DRIVE SE DECISION MADE: 21-APR-06
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER PLATING SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K060798(SPECIAL)
ATTN: VIVIAN KELLY PHONE NO : 201-831-5581
325 CORPORATE DRIVE SE DECISION MADE: 12-APR-06
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S2 RECON NAIL SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K060921(SPECIAL)
ATTN: FRANCISCO HARO PHONE NO : 201-831-5493
325 CORPORATE DRIVE SE DECISION MADE: 13-APR-06
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPEDIMED - BODY COMPOSITION ANALYZER, MODEL IMP SFB7
IMPEDIMED PTY LTD. 510(k) NO: K052319(TRADITIONAL)
ATTN: NEVILLE BERTWISTLE PHONE NO : 617 342 31777
BUILDING 4B/2404 LOGAN ROAD SE DECISION MADE: 04-APR-06
EIGHT MILE PLAINS 510(k) SUMMARY AVAILABLE FROM FDA
BRISBANE, QUEENSLAND, AUSTRALIA 4113
DEVICE: INDITHERM PATIENT WARMING SYSTEM, MODELS MECU1; OTM1; OTM2; GTM1
INDITHERM MEDICAL 510(k) NO: K051419(TRADITIONAL)
ATTN: M.W. (ANDY) ANDERSON PHONE NO : 952-746-8079
5353 WAYZATA BLVD. SUITE 505 SE DECISION MADE: 27-APR-06
MINNEAPOLIS, MN 55416 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOSIL SYNTHASIL
INSTRUMENTATION LABORATORY CO. 510(k) NO: K060688(SPECIAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 13-APR-06
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTACT BREAST LESION EXCISION SYSTEM AND ADVANCE
INTACT MEDICAL CORPORATION 510(k) NO: K060413(TRADITIONAL)
ATTN: DAVID JACOBS PHONE NO : 508-655-7820
ONE APPLE HILL SUITE 316 SE DECISION MADE: 27-APR-06
NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTELIFUSE, INC., WARMSYSTEM WITH STIMULINKS
INTELIFUSE, INC. 510(k) NO: K060014(TRADITIONAL)
ATTN: SHARON ROCKWELL PHONE NO : 714-695-9269
5582 CHALON ROAD SE DECISION MADE: 03-APR-06
YORBA LINDA, CA 92886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTUITIVE SURGICAL ENDOWRIST STABILIZER, MODEL 420182
INTUITIVE SURGICAL, INC. 510(k) NO: K060391(SPECIAL)
ATTN: MICHAEL J HYRAMATEGUI PHONE NO : 408-523-2100
950 KIFER RD. SE DECISION MADE: 10-APR-06
SUNNYVALE, CA 94086-5206 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IBA PROTON THERAPY SYSTEM - PROTEUS 235
ION BEAM APPLICATIONS S.A. 510(k) NO: K060695(SPECIAL)
ATTN: JOHN B REISS PHONE NO : 215-972-7124
CENTRE SQUARE WEST SE DECISION MADE: 11-APR-06
1500 MARKET STREET, 38TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
PHILADELPHIA, PA 19102-2186
DEVICE: INQUIRY OPTIMA PLUS STEERABLE ELECTROPHYSIOLOGY CATHETER
IRVINE BIOMEDICAL, INC. 510(k) NO: K060757(SPECIAL)
ATTN: DENNIS HONG PHONE NO : 949-271-1134
2375 MORSE AVE. SE DECISION MADE: 19-APR-06
IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITRIFICATION FREEZE KIT, VITRIFICATION THAW KIT
IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K060168(TRADITIONAL)
ATTN: WENDELL LEE PHONE NO : 800-437-5706
2511 DAIMLER ST. SE DECISION MADE: 24-APR-06
SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APEXCAL
IVOCLAR VIVADENT, INC. 510(k) NO: K060365(TRADITIONAL)
ATTN: DONNA M HARTNETT PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 17-APR-06
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: CIDEX ACTIVATED DIALDEHYDE SOLUTION
JOHNSON & JOHNSON CO. 510(k) NO: K060618(SPECIAL)
ATTN: JOSEPH M ASCENZI PHONE NO : 949-453-6352
33 TECHNOLOGY DR SE DECISION MADE: 12-APR-06
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THROMCAT THROMBECTOMY CATHETER SYSTEM
KENSEY NASH CORP. 510(k) NO: K060016(TRADITIONAL)
ATTN: JENNIFER J BOSLEY PHONE NO : 610-594-4582
735 PENNSYLVANIA AVE. SE DECISION MADE: 25-APR-06
EXTON, PA 19341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PREMISE FLOWABLE
KERR CORPORATION 510(k) NO: K060472(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 949-255-8766
100 BAYVIEW CIRCLE STE 6000 SE DECISION MADE: 28-APR-06
NEWPORT BEACH, CA 92660 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KLS MARTIN RIGID FIXATION - STERILE
KLS MARTIN L.P. 510(k) NO: K060177(TRADITIONAL)
ATTN: JENNIFER DAMATO PHONE NO : 904-641-7746
11239 ST. JOHNS INDUSTRIAL SE DECISION MADE: 18-APR-06
PARKWAY SOUTH 510(k) SUMMARY AVAILABLE FROM FDA
JACKSONVILLE, FL 32246
DEVICE: NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN PROGESTERONE RECEPTOR AN
LAB VISION CORP. 510(k) NO: K060462(TRADITIONAL)
ATTN: GRACE CHANG PHONE NO : 510-991-2854
47777 WARM SPRINGS BLVD. SE DECISION MADE: 24-APR-06
FREMONT, CA 94539 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LADY COMP USA
LADY COMP USA 510(k) NO: K050094(TRADITIONAL)
ATTN: MICHAEL CARTAIN PHONE NO : 502-905-2601
410 EAST TERRACE HEIGHTS SE DECISION MADE: 20-APR-06
JEFFERSONVILLE, IN 47130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VELSCOPE
LED MEDICAL DIAGNOSTICS INC. 510(k) NO: K060920(TRADITIONAL)
ATTN: DAVID C MORGAN PHONE NO : 604 541 4614 X262
#201-15047 MARINE DR. SE DECISION MADE: 27-APR-06
WHITE ROCK, BRITISH COLUMBIA, CANA510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM
LENSTEC, INC. 510(k) NO: K060533(TRADITIONAL)
ATTN: LUIS RUIZ PHONE NO : 727-571-2272
2870 SCHERER DR., SUITE 300 SE DECISION MADE: 14-APR-06
ST. PETERSBURG, FL 33716 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AWQ-104
LHASA OMS, INC. 510(k) NO: K050989(TRADITIONAL)
ATTN: MARK W SHEEHAN PHONE NO : 781-340-1072
230 LIBBEY PKWY. SE DECISION MADE: 06-APR-06
WEYMOUTH, MA 02189 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIBERTY NORMAL GLUCOSE CONTROL SOLUTION
LIBERTY HEALTHCARE GROUP, INC. 510(k) NO: K060706(TRADITIONAL)
ATTN: JOHN C GORMLEY PHONE NO : 830-372-1391
940 CROSSROADS BLVD. SE DECISION MADE: 28-APR-06
SEGUIN, TX 78155 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PREFTEST PROFESSIONAL SUITE
LIMESTONE TECHNOLOGIES INC. 510(k) NO: K052929(TRADITIONAL)
ATTN: NANCY RUTH PHONE NO : 905 689 3980
4 INNOVATION DRIVE SE DECISION MADE: 26-APR-06
DUNDAS, CANADA L9H 7P3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AN
LIN-ZHI INTERNATIONAL, INC. 510(k) NO: K050988(TRADITIONAL)
ATTN: MARIE LIN PHONE NO : 408-732-3856
687 NORTH PASTORIA AVE. SE DECISION MADE: 06-APR-06
SUNNYVALE, CA 94085-2917 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROPOWER HAND PIECE HIGH SPEED DRILL
LINVATEC CORP. 510(k) NO: K060260(SPECIAL)
ATTN: ELIZABETH PAUL PHONE NO : 727-399-5234
11311 CONCEPT BLVD. SE DECISION MADE: 10-APR-06
LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL
LINVATEC CORP. 510(k) NO: K060270(SPECIAL)
ATTN: ELIZABETH PAUL PHONE NO : 727-399-5234
11311 CONCEPT BLVD. SE DECISION MADE: 10-APR-06
LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGHTSHEER DUET LASER SYSTEM
LUMENIS, INC. 510(k) NO: K053628(TRADITIONAL)
ATTN: CONNIE HOY PHONE NO : 408-764-3303
2400 CONDENSA ST. SE DECISION MADE: 07-APR-06
SANTA CLARA, CA 95051-0901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BILISOFT PHOTOTHERAPY SYSTEM
LUMITEX, INC. 510(k) NO: K053568(TRADITIONAL)
ATTN: JEFF WILLIAMS PHONE NO : 440-243-8401
8443 DOW CIR. SE DECISION MADE: 17-APR-06
STRONGSVILLE, OH 44136 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MCKINLEY SATURATION CATHETER
MCKINLEY MEDICAL LLC 510(k) NO: K060119(TRADITIONAL)
ATTN: JOHN CHAPPELL PHONE NO : 303-420-9569
4080 YOUNGFIELD ST. SE DECISION MADE: 12-APR-06
WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OHMEGA
MEDICAL MEASUREMENT SYSTEMS,B.V. 510(k) NO: K060166(TRADITIONAL)
ATTN: K. OGINK-SOMHORST PHONE NO : 315 348 03739
COLOSSEUM 25 SE DECISION MADE: 21-APR-06
ENSCHEDE, NETHERLANDS 7521 PV 510(k) STATEMENT
DEVICE: ATRILAZE SURGICAL ABLATION SYSTEM
MEDICALCV, INC. 510(k) NO: K060680(SPECIAL)
ATTN: DENNY STEGER PHONE NO : 651-452-3000
9725 SOUTH ROBERT TRAIL SE DECISION MADE: 11-APR-06
INVER GROVE HEIGHTS, MN 55077 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO VERTE-STACK SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K060719(SPECIAL)
ATTN: EDWARD S CHIN PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 14-APR-06
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRAVEL PAL (MM-111B) /MEGA MOTION
MEGA MOTION, INC. 510(k) NO: K060697(SPECIAL)
ATTN: MARK CALOMINO PHONE NO : 888-415-1200
957 WOOD ST. SE DECISION MADE: 11-APR-06
OLD FORGE, PA 18518 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESCUE IMPLANT SYSTEM
MEGAGEN CO., LTD. 510(k) NO: K053353(TRADITIONAL)
ATTN: DAE CHANG PHONE NO : 562-404-8466
13340 E. FIRESTONE BLVD. SE DECISION MADE: 19-APR-06
SUITE J 510(k) SUMMARY AVAILABLE FROM FDA
SANTA FE SPRINGS, CA 90670
DEVICE: INTERMEZZO PLUS FIXTURE
MEGAGEN CO., LTD. 510(k) NO: K053354(TRADITIONAL)
ATTN: DAE CHANG PHONE NO : 562-404-8466
13340 E. FIRESTONE BLVD. SE DECISION MADE: 13-APR-06
SUITE J 510(k) SUMMARY AVAILABLE FROM FDA
SANTA FE SPRINGS, CA 90670
DEVICE: NEXUS DETACHABLE COIL SYSTEM, MORPHEUS 3D CSR
MICRO THERAPEUTICS, INC. 510(k) NO: K060625(SPECIAL)
ATTN: FLORIN TRUUVERT PHONE NO : 949-837-3700
2 GOODYEAR SE DECISION MADE: 20-APR-06
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICRUS GUIDE WIRE, WATUSI 0.014
MICRUS ENDOVASCULAR CORPORATION 510(k) NO: K053265(TRADITIONAL)
ATTN: MARGARET WEBBER PHONE NO : 408-830-5900
610 PALOMAR AVENUE SE DECISION MADE: 28-APR-06
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINXRAY, MODELS HFP24 AND HFP40
MIKASA X-RAY CO., LTD. 510(k) NO: K060566(SPECIAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 05-APR-06
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855
MONITEX INDUSTRIAL CO., LTD. 510(k) NO: K060646(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN STREET SE DECISION MADE: 21-APR-06
HSIN CHU CITY, CHINA (TAIWAN) 3006510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SVIEW
MRI CARDIAC SERVICES, INCORPORATED510(k) NO: K060840(TRADITIONAL)
ATTN: S. SCOTT HUBER PHONE NO : 336-831-1908
8 WEST THIRD ST. SUITE M9 SE DECISION MADE: 07-APR-06
WINSTON-SALEM, NC 27101 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: V-505 INFA WARMER
NEOFORCE GROUP, INC. 510(k) NO: K060461(SPECIAL)
ATTN: MARY STANIEWICZ PHONE NO : 215-794-0495
35 COMMERCE DR. SE DECISION MADE: 28-APR-06
IVYLAND, PA 18974 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURTRAK IMPLANTATION KIT
NORTH AMERICAN SCIENTIFIC, INC. 510(k) NO: K060679(TRADITIONAL)
ATTN: LEIGH SPOTTEN PHONE NO : 818-734-8600
20200 SUNBURST ST. SE DECISION MADE: 21-APR-06
CHATSWORTH, CA 91311 510(k) STATEMENT
DEVICE: ENDOSSEOUS DENTAL IMPLANT SYSTEM
NORTHERN IMPLANTS, LLC 510(k) NO: K053478(TRADITIONAL)
ATTN: GRETA M HOLS PHONE NO : 703-278-3953
10355 B DEMOCRACY LANE SE DECISION MADE: 05-APR-06
FAIRFAX, VA 22030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIO
NOVA BIOMEDICAL CORP. 510(k) NO: K060345(TRADITIONAL)
ATTN: PAUL W MACDONALD PHONE NO : 781-894-0800
200 PROSPECT ST. SE DECISION MADE: 28-APR-06
WALTHAM, MA 02454-9141 510(k) STATEMENT
DEVICE: NOVABONE POROUS-BONE GRAFT SCAFFOLD
NOVABONE PRODUCTS, LLC 510(k) NO: K060432(TRADITIONAL)
ATTN: DAVID M GAISSER PHONE NO : 386-462-7660
13709 PROGRESS BLVD., #33 SE DECISION MADE: 04-APR-06
ALACHUA, FL 32615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUVASIVE SPHERX SYSTEM
NUVASIVE, INC. 510(k) NO: K060225(SPECIAL)
ATTN: LAETITIA COUSIN PHONE NO : 858-909-1868
4545 TOWNE CENTRE CT. SE DECISION MADE: 12-APR-06
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGELLAN-2200 MODEL -2 ANESTHESIA MACHINE, MODEL 2
OCEANIC MEDICAL PRODUCTS, INC. 510(k) NO: K060193(TRADITIONAL)
ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5600
555 THIRTEENTH STREET, NW. SE DECISION MADE: 10-APR-06
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STETHOFLUX
ODVI 510(k) NO: K060064(TRADITIONAL)
ATTN: ARMELLE LAPRELLE PHONE NO : 331 690 70337
69 RUE DE PARIS SE DECISION MADE: 10-APR-06
ORSAY, FRANCE 91400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IVIEW
ONDEMANDSOFT 510(k) NO: K053306(TRADITIONAL)
ATTN: IAN P GORDON PHONE NO : 727-797-4727
2454 MCMULLEN BOOTH ROAD SE DECISION MADE: 19-APR-06
STE 427 510(k) SUMMARY AVAILABLE FROM FDA
CLEARWATER, FL 33759
DEVICE: ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS
ORTHO DEVELOPMENT CORP. 510(k) NO: K060577(TRADITIONAL)
ATTN: WILLIAM J GRIFFIN PHONE NO : 801-619-3470
12187 SOUTH BUSINESS PARK DR. SE DECISION MADE: 28-APR-06
DRAPER, UT 84020 510(k) STATEMENT
DEVICE: VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314; VIT
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K060650(SPECIAL)
ATTN: MICHAEL M BYRNE PHONE NO : 585-453-3143
100 INDIGO CREEK DR. SE DECISION MADE: 06-APR-06
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 99, VITROS CHEMISTRY PR
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K060940(TRADITIONAL)
ATTN: MARLENE HANNA PHONE NO : 585-453-4041
100 INDIGO CREEK DR. SE DECISION MADE: 24-APR-06
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002
ORTHOSOFT, INC. 510(k) NO: K060336(SPECIAL)
ATTN: CHRISTOPHER MCLEAN PHONE NO : 514 861 4074
75 QUEEN ST., SUITE 3300 SE DECISION MADE: 28-APR-06
MONTREAL, QUEBEC, CANADA H3C 2N6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEOMED ORTHODONTIC ANCHOR PLATING SYSTEM
OSTEOMED L.P. 510(k) NO: K051798(TRADITIONAL)
ATTN: DAWN T HOLDERMAN PHONE NO : 972-677-4600
3885 ARAPAHO RD. SE DECISION MADE: 07-APR-06
ADDISON, TX 75001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TREK S NEBULIZER COMPRESSOR
PARI INNOVATIVE MANUFACTURERS, INC510(k) NO: K060357(TRADITIONAL)
ATTN: MICHAEL JUDGE PHONE NO : 804-253-7274
2943 OAK LAKE BLVD. SE DECISION MADE: 05-APR-06
MIDLOTHIAN, VA 23112 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PENUMBRA BALLOON GUIDE CATHETER, MODEL 7.5F
PENUMBRA, INC. 510(k) NO: K053491(TRADITIONAL)
ATTN: THERESA BRANDNER-ALLEN PHONE NO : 510-618-3223
2401 MERCED ST., SUITE 200 SE DECISION MADE: 27-APR-06
SAN LEANDRO, CA 94577 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMFORT/IO IONTOPHORESIS ELECTRODES
PEPIN MFG., INC. 510(k) NO: K060579(ABBREVIATED)
ATTN: GARY SYRING PHONE NO : 608-877-2635
800 LEVANGER LANE SE DECISION MADE: 20-APR-06
STOUGHTON, WI 53589 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XPERCT
PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K060749(TRADITIONAL)
ATTN: LYNN HARMER PHONE NO : 425-487-7312
22100 BOTHELL EVERETT HWY. SE DECISION MADE: 04-APR-06
MS 915 510(k) SUMMARY AVAILABLE FROM FDA
BOTHELL, WA 98041-3003 THIRD PARTY REVIEW
DEVICE: CAAS MRV VERSION 3.0
PIE MEDICAL IMAGING B.V. 510(k) NO: K060941(SPECIAL)
ATTN: CARL M BEAURLINE PHONE NO : 952-941-3507
7450 FLYING CLOUD DR. SE DECISION MADE: 19-APR-06
EDEN PRAIRIE, MN 55344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLANAR DOME EX LINE MODEL DOME E2C
PLANAR SYSTEMS, INC. 510(k) NO: K061018(TRADITIONAL)
ATTN: CRAIG HARSHMAN PHONE NO : 503-748-4661
1195 NW COMPTON DRIVE SE DECISION MADE: 28-APR-06
BEAVERTON, OR 97006 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PTS PANELS HDL CHOLESTEROL TEST STRIPS
POLYMER TECHNOLOGY SYSTEMS, INC. 510(k) NO: K060617(SPECIAL)
ATTN: MARGO ENRIGHT PHONE NO : 317-870-5610
7736 ZIONSVILLE RD. SE DECISION MADE: 05-APR-06
INDIANAPOLIS, IN 46268 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGETICS ORTHO OSTEOLOGICS NAVIGATION SYSTEM
PRAXIM SA 510(k) NO: K053542(TRADITIONAL)
ATTN: RANDY VEALE PHONE NO : 719-495-3438
49 PLAIN STREET SE DECISION MADE: 10-APR-06
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOTAL KNEE SURGETICS NAVIGATION SYSTEM
PRAXIM SA 510(k) NO: K060282(SPECIAL)
ATTN: RANDY VEALE PHONE NO : 719-495-3438
49 PLAIN STREET SE DECISION MADE: 10-APR-06
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROACT WITH GEL OR PROACT 1
PROACT INC. 510(k) NO: K052243(TRADITIONAL)
ATTN: JOSEPH M AZARY PHONE NO : 203-944-9320
543 LONG HILL AVENUE SE DECISION MADE: 12-APR-06
SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LASERTX - DIODE LASER & DELIVERY SYSTEM
PROSURG, INC. 510(k) NO: K060326(TRADITIONAL)
ATTN: ASHVIN DESAI PHONE NO : 408-945-4044
2193 TRADE ZONE BLVD. SE DECISION MADE: 05-APR-06
SAN JOSE, CA 95131 510(k) STATEMENT
DEVICE: MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS S
PURITAN BENNETT CORP. 510(k) NO: K053388(TRADITIONAL)
ATTN: JAMES BONDS PHONE NO : 925-463-4371
4280 HACIENDA DR. SE DECISION MADE: 04-APR-06
PLEASANTON, CA 94588-2719 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: QUANTUM VERTEBRAL BODY REPLACEMENT
QUANTUM ORTHOPEDICS, INC. 510(k) NO: K052641(SPECIAL)
ATTN: JASON BLAIN PHONE NO : 760-607-0121
2744 LOKER AVE. W. SUITE 100 SE DECISION MADE: 12-APR-06
CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOGEL LATEX POWDER FREE STERILE SURGEON'S GLOVE
REGENT MEDICAL AMERICAS, LLC 510(k) NO: K053441(TRADITIONAL)
ATTN: KATHLEEN HARRIS PHONE NO : 678-250-7900
3585 ENGINEERING DR, STE 250 SE DECISION MADE: 10-APR-06
NORCROSS, GA 30092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RENU MEDICAL REPROCESSED ALP 1 CALF GARMENT, MODEL ALP1
RENU MEDICAL, INC. 510(k) NO: K051227(TRADITIONAL)
ATTN: GEORGE BIGGINS PHONE NO : 425-353-1110
9800 EVERGREEN WAY SE DECISION MADE: 07-APR-06
EVERETT, WA 98204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VPAP III ST-A/KIDSTA MASK SYSTEM
RESMED LTD. 510(k) NO: K060105(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858-746-2238
14040 DANIELSON ST. SE DECISION MADE: 07-APR-06
POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEANER ROTATIONAL THROMBECTOMY SYSTEM
REX MEDICAL LP 510(k) NO: K060904(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502
55 NORTHERN BLVD. SE DECISION MADE: 28-APR-06
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: ELECSYS TSH CALSET W/MODELS 04738551
ROCHE DIAGNOSTICS CORP. 510(k) NO: K060754(SPECIAL)
ATTN: KAY A TAYLOR PHONE NO : 317-521-3544
9115 HAGUE RD. SE DECISION MADE: 18-APR-06
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK
ROCHE DIAGNOSTICS CORP. 510(k) NO: K060755(SPECIAL)
ATTN: RANDY J JOHNSON PHONE NO : 317-521-3532
9115 HAGUE RD. SE DECISION MADE: 10-APR-06
P.O. BOX 50457 510(k) SUMMARY AVAILABLE FROM FDA
INDIANAPOLIS, IN 46250-0457
DEVICE: SEE-IT CARIES DETECTOR
RONVIG DENTAL MFG. A/S 510(k) NO: K060330(TRADITIONAL)
ATTN: ANNETTE RAVN NIELSEN PHONE NO : 45 70 233411
GL. VEJLEVEJ 59 SE DECISION MADE: 07-APR-06
DAUGAARD, DENMARK DK-8721 510(k) STATEMENT
DEVICE: ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR MODEL MO701K
ROSSMAX INTERNATIONAL LTD. 510(k) NO: K060342(ABBREVIATED)
ATTN: MARK LIN PHONE NO : 886 265 97888X519
12F., NO.189, KANG CHIEN RD. SE DECISION MADE: 04-APR-06
TAIPEI, CHINA (TAIWAN) 114 510(k) STATEMENT
DEVICE: TONOMETER DIATON
RYAZAN STATE INSTRUMENTS 510(k) NO: K060780(TRADITIONAL)
ATTN: BORIS KUN PHONE NO : 516-431-3859
151 EAST WALNUT STREET SE DECISION MADE: 06-APR-06
LONG BEACH, NY 11561 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO: TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTE
SAFETY SYRINGES, INC. 510(k) NO: K060743(TRADITIONAL)
ATTN: THOMAS L HALL PHONE NO : 760-918-9908
1939 PALOMAR OAKS WAY, SUITE A SE DECISION MADE: 28-APR-06
CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM
SCANDIUS BIOMEDICAL, INC. 510(k) NO: K060522(TRADITIONAL)
ATTN: ERIC BANNON PHONE NO : 978-486-4088
11A BEAVER BROOK ROAD SE DECISION MADE: 11-APR-06
LITTLETON, MA 01460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASP TITANIUM
SEDATELEC 510(k) NO: K060392(SPECIAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
13 RED FOX LANE SE DECISION MADE: 26-APR-06
LITTLETON, CO 80127 510(k) STATEMENT
DEVICE: VANGUARD MRI AUXILIARY PATIENT TABLE WITH 4 AND 8 CHANNEL COIL A
SENTINELLE MEDICAL, INC. 510(k) NO: K060873(TRADITIONAL)
ATTN: CAMERON PIRON PHONE NO : 416 482 3828
3080 YONGE STREET SE DECISION MADE: 14-APR-06
SUITE 6020 510(k) SUMMARY AVAILABLE FROM FDA
TORONTO, ONTARIO, CANADA M4N 3N1 THIRD PARTY REVIEW
DEVICE: NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE WITH PO
SIAM SEMPERMED CORP. LTD. 510(k) NO: K060753(ABBREVIATED)
ATTN: WILLIAM E HARRIS PHONE NO : 727-787-7250
13900 49TH STREET NORTH SE DECISION MADE: 27-APR-06
CLEARWATER, FL 33762 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DOSE VERIFICATION SYSTEM
SICEL TECHNOLOGIES, INC. 510(k) NO: K052118(TRADITIONAL)
ATTN: TAMMY B CARREA PHONE NO : 919-465-2236
3800 GATEWAY CENTRE BLVD. SE DECISION MADE: 03-APR-06
SUITE 308 510(k) SUMMARY AVAILABLE FROM FDA
MORRISVILLE, NC 27560
DEVICE: SYNGO US WORKPLACE
SIEMENS MEDICAL SOLUTIONS 510(k) NO: K060992(TRADITIONAL)
ATTN: SHEILA W PICKERING PHONE NO : 650-943-7187
1230 SHOREBIRD WAY SE DECISION MADE: 28-APR-06
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODEL EC9-4 TRANSDUCER
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K060879(SPECIAL)
ATTN: PATRICK LYNCH PHONE NO : 425-557-1825
1230 SHOREBIRD WAY SE DECISION MADE: 19-APR-06
P O BOX 7393 510(k) SUMMARY AVAILABLE FROM FDA
MOUNTAIN VIEW, CA 94039-7393
DEVICE: SIMPLER THREADED HA COATED, MODELS ST 5002-5016; SIMPLER THREADE
SIMPLER IMPLANT, INC. 510(k) NO: K060376(SPECIAL)
ATTN: KAREN BERGMAN PHONE NO : 604 736 9800
404-1023 WOLFE AVENUE SE DECISION MADE: 25-APR-06
VANCOUVER, BC, CANADA V6H 1V6 510(k) STATEMENT
DEVICE: GALILEOS
SIRONA DENTAL SYSTEMS GMBH 510(k) NO: K060892(TRADITIONAL)
ATTN: FRITZ KOLLE PHONE NO : 496 251 163294
FABRIKSTRASSE 31 SE DECISION MADE: 14-APR-06
BENSHEIM, GERMANY D-64625 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: VERSAJET HYDROSURGERY SYSTEM AND HANDPIECE
SMITH & NEPHEW WOUND MANAGEMENT 510(k) NO: K060782(TRADITIONAL)
ATTN: TERRY MCMAHON PHONE NO : 727-392-1261
11775 STARKEY ROAD SE DECISION MADE: 12-APR-06
LARGO, FL 33773 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW 6.5MM AND 8.0MM CANNULATED SCREWS
SMITH & NEPHEW, INC. 510(k) NO: K060736(SPECIAL)
ATTN: DAVID HENSLEY PHONE NO : 901-399-6487
1450 BROOKS RD. SE DECISION MADE: 18-APR-06
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW MODEL 660HD IMAGE MANAGEMENT SYSTEM
SMITH & NEPHEW, INC. 510(k) NO: K060777(SPECIAL)
ATTN: KATHLEEN BURNS PHONE NO : 978-474-6301
150 MINUTEMAN RD. SE DECISION MADE: 13-APR-06
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VUMAX
SONOMED, INC. 510(k) NO: K060626(SPECIAL)
ATTN: GEORGE MYERS PHONE NO : 201-737-1703
377 ROUTE 17 S SE DECISION MADE: 11-APR-06
HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOURCE PRODUCTION & EQUIPMENT CO, INC., MODEL M-19 IR-192 BRACHY
SOURCE PRODUCTION & EQUIPMENT CO.,510(k) NO: K052947(TRADITIONAL)
ATTN: JOHN J MUNRO PHONE NO : 504-464-9471
113 TEAL STREET SE DECISION MADE: 19-APR-06
ST. ROSE, LA 70087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES
SPACELABS MEDICAL INC. 510(k) NO: K053599(SPECIAL)
ATTN: AL VAN HOUDT PHONE NO : 425-657-7200
5150 220TH AVE SE SE DECISION MADE: 19-APR-06
ISSAQUAH, WA 98029 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPECTRAGENICS ATS-1
SPECTRAGENICS, INC. 510(k) NO: K060567(TRADITIONAL)
ATTN: ROBERT E GROVES PHONE NO : 925-701-2549
5880 WEST LAS POSITAS BLVD. SE DECISION MADE: 28-APR-06
SUITE 52 510(k) SUMMARY AVAILABLE FROM FDA
PLEASANTON, CA 94588
DEVICE: SLIMPLICITY ANTERIOR CERVICAL PLATE SYSTEM
SPINAL USA 510(k) NO: K060025(TRADITIONAL)
ATTN: JEFFREY JOHNSON PHONE NO : 601-992-7668
213 EASTSIDE LANE SE DECISION MADE: 18-APR-06
BRANDON, MS 39047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STAXX XD SYSTEM
SPINE WAVE, INC. 510(k) NO: K052670(TRADITIONAL)
ATTN: RONALD K SMITH PHONE NO : 203-944-9494
TWO ENTERPRISE DR. SE DECISION MADE: 27-APR-06
SUITE 302 510(k) SUMMARY AVAILABLE FROM FDA
SHELTON, CT 06484
DEVICE: MODIFICATION TO ENSITE SYSTEM, MODEL EE3000
ST. JUDE MEDICAL, INC.-ENDOCARDIAL510(k) NO: K060954(SPECIAL)
ATTN: KAREN J MCKELVEY PHONE NO : 651-632-9454
1350 ENERGY LN., SUITE 110 SE DECISION MADE: 21-APR-06
ST. PAUL, MN 55108-5254 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HDR 1000 PLUS WELL CHAMBER, MODEL 90008
STANDARD IMAGING, INC. 510(k) NO: K060532(TRADITIONAL)
ATTN: RAYMOND RIDDLE PHONE NO : 608-831-0025
7601 MURPHY DR. SE DECISION MADE: 11-APR-06
MIDDLETON, WI 53562-2766 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER INJECTABLE CEMENT
STRYKER CMF 510(k) NO: K060750(TRADITIONAL)
ATTN: WADE T RUTKOSKIE PHONE NO : 877-534-2464
750 TRADE CENTRE WAY SE DECISION MADE: 19-APR-06
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISUM LED SURGICAL LIGHTING SYSTEM
STRYKER COMMUNICATIONS CORP. 510(k) NO: K060802(TRADITIONAL)
ATTN: LOUIS-PIERRE MARCOUX PHONE NO : 972-410-7111
1410 LAKESIDE PKWY., #100 SE DECISION MADE: 07-APR-06
FLOWER MOUND, TX 75028 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: STRYKER SCOPE/INSTRUMENT HOLDER
STRYKER ENDOSCOPY 510(k) NO: K060085(TRADITIONAL)
ATTN: CRYSTAL ONG PHONE NO : 408-754-2491
5900 OPTICAL CT. SE DECISION MADE: 27-APR-06
SAN JOSE, CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO XIA 4.5 SPINAL SYSTEM
STRYKER SPINE 510(k) NO: K060748(SPECIAL)
ATTN: SIMONA VOIC PHONE NO : 201-760-8145
2 PEARL COURT SE DECISION MADE: 13-APR-06
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECHOHEART TRANSVAGINAL DOPPLER PROBE
SUMMIT DOPPLER SYSTEMS, INC. 510(k) NO: K060410(TRADITIONAL)
ATTN: KEN JARRELL PHONE NO : 303-423-7572
4620 TECHNOLOGY DR. UNIT 100 SE DECISION MADE: 10-APR-06
GOLDEN, CO 80403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NORIAN CRS FAST SET PUTTY
SYNTHES (USA) 510(k) NO: K060443(TRADITIONAL)
ATTN: ANGELA J SILVESTRI PHONE NO : 484-356-9728
1302 WRIGHTS LANE EAST SE DECISION MADE: 13-APR-06
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NORIAN CRS BONE CEMENT
SYNTHES (USA) 510(k) NO: K060445(TRADITIONAL)
ATTN: ANGELA SILVESTRI PHONE NO : 484-356-9728
1302 WRIGHTS LANE EAST SE DECISION MADE: 13-APR-06
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.002-16UG/ML FOR GRAM N
TDS HOLDINGS INC. 510(k) NO: K060621(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 800-871-8909
982 KEYNOTE CIRCLE, SUITE 6 SE DECISION MADE: 21-APR-06
CLEVELAND, OH 44131 510(k) STATEMENT
DEVICE: TECHLAB ASCA-CHEK
TECHLAB, INC. 510(k) NO: K051927(TRADITIONAL)
ATTN: DAVID M LYERLY PHONE NO : 540-953-1664
2001 KRAFT DR. SE DECISION MADE: 06-APR-06
BLACKSBURG, VA 24060-6358 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C. DIFF QUIK CHEK
TECHLAB, INC. 510(k) NO: K053572(TRADITIONAL)
ATTN: DAVID M LYERLY PHONE NO : 540-953-1664
2001 KRAFT DR. SE DECISION MADE: 26-APR-06
BLACKSBURG, VA 24060-6358 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES
TERUMO EUROPE N.V. 510(k) NO: K053413(TRADITIONAL)
ATTN: M.J. AERTS PHONE NO : 003 216 381211
RESEARCHPARK ZONE 2 SE DECISION MADE: 06-APR-06
INTERLEUVENLAAN 40 510(k) SUMMARY AVAILABLE FROM FDA
LEUVEN, BELGIUM 3001
DEVICE: RAPID FORSURE ONE STEP MULTIPLE DRUG (UP TO 6) SCREEN TEST DEVIC
TIANJIN NEW BAY BIORESEARCH CO., L510(k) NO: K052520(TRADITIONAL)
ATTN: RODRIGO BERLIE PHONE NO : 760-602-2929
3108 AVENIDA OLMEDA SE DECISION MADE: 24-APR-06
CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUPER SHEATH XL INTRODUCER SHEATH
TOGO MEDIKIT CO., LTD. 510(k) NO: K060190(SPECIAL)
ATTN: HEIDI M ERICKSON PHONE NO : 763-694-3028
5905 NATHAN LANE SE DECISION MADE: 04-APR-06
MAIL STOP P-25 510(k) SUMMARY AVAILABLE FROM FDA
PLYMOUTH, MN 55442
DEVICE: MODIFICATION TO: HI-ART SYSTEM
TOMOTHERAPY INCORPORATED 510(k) NO: K060912(SPECIAL)
ATTN: KENNETH D BUROKER PHONE NO : 608-824-2811
1240 DEMING WAY SE DECISION MADE: 19-APR-06
MADISON, WI 53717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RHS
TORNIER 510(k) NO: K060438(TRADITIONAL)
ATTN: MIREILLE LEMERY PHONE NO : 003 347 6613898
161 RUE LAVOISIER SE DECISION MADE: 18-APR-06
MONTBONNOT, SAINT-ISMIER, FRANCE 3510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNITY HUMERAL PLATE
TORNIER 510(k) NO: K060545(TRADITIONAL)
ATTN: MIREILLE LEMERY PHONE NO : 003 347 6613898
RUE DOYEN GOSSE SE DECISION MADE: 21-APR-06
ST. ISMIER, FRANCE 38330 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABARIS
TRAXTAL TECHNOLOGIES INC. 510(k) NO: K053610(TRADITIONAL)
ATTN: NEIL GLOSSOP PHONE NO : 416 603 8349
49 SPADINA AVENUE, #402C SE DECISION MADE: 19-APR-06
TORONTO, ONTARIO, CANADA M5V 2J1 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67
TRIPATH IMAGING, INC. 510(k) NO: K053520(TRADITIONAL)
ATTN: BRYAN J TUCKER PHONE NO : 919-206-7166
4025 STIRRUP CREEK DRIVE SE DECISION MADE: 11-APR-06
STE. 400 510(k) STATEMENT
DURHAM, NC 27703
DEVICE: KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH SYR
TYCO HEALTHCARE/KENDALL 510(k) NO: K060339(SPECIAL)
ATTN: BRIDGET GARDNER PHONE NO : 508-261-6384
15 HAMPSHIRE STREET SE DECISION MADE: 28-APR-06
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G4, MODEL IGM-0004
U. S. DIAGNOSTICS, INC. 510(k) NO: K051651(TRADITIONAL)
ATTN: EDWARD LETKO PHONE NO : 212-674-3636
304 PARK AVENUE SOUTH SE DECISION MADE: 14-APR-06
SUITE 218 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10010
DEVICE: EUREKA INFUSION PUMP, MODELS EUREKA-IP, EUREKA-LF
UNIVERSAL MEDICAL TECHNOLOGIES 510(k) NO: K052817(TRADITIONAL)
ATTN: GLENN HERSKOWITZ PHONE NO : 415-924-1133
PO BOX 5155 SE DECISION MADE: 17-APR-06
KARKSPUR, CA 94977-5155 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIVAWAVE MICROWAVE ABLATION SYSTEM
VALLEYLAB 510(k) NO: K053535(TRADITIONAL)
ATTN: HERBERT VINSON PHONE NO : 303-530-6469
5920 LONGBOW DR. SE DECISION MADE: 27-APR-06
BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VALPLAST YAMAHACHI TEETH
VALPLAST INTL. CORP. 510(k) NO: K060507(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 07-APR-06
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BURBANK TENACULUM
VASCULAR CONTROL SYSTEMS, INC 510(k) NO: K060573(TRADITIONAL)
ATTN: KATHLEEN ROBERTS PHONE NO : 949-488-8700
32236-F PASEO ADELANTO SE DECISION MADE: 21-APR-06
SAN JUAN CAPISTRANO, CA 92675 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER AND SKYWAY SUP
VASCULAR SOLUTIONS, INC. 510(k) NO: K060327(TRADITIONAL)
ATTN: JULIE TAPPER PHONE NO : 763-656-4228
6464 SYCAMORE COURT NORTH SE DECISION MADE: 12-APR-06
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAKED
VERAXIS INT'L INC. 510(k) NO: K060797(TRADITIONAL)
ATTN: JULES T MITCHEL PHONE NO : 212-681-2100
261 MADISON AVENUE SE DECISION MADE: 07-APR-06
24TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10016 THIRD PARTY REVIEW
DEVICE: SWIRLGRAFT VASCULAR ACCESS GRAFT
VERYAN MEDICAL LIMITED 510(k) NO: K060741(SPECIAL)
ATTN: SEMITH OKTAY PHONE NO : 360-904-6512
1327 BLUEGRASS WAY SE DECISION MADE: 05-APR-06
GAMBRILLS, MD 21054 510(k) STATEMENT
DEVICE: VITA VM 7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODE
VIDENT 510(k) NO: K060441(TRADITIONAL)
ATTN: BARBARA J LEWANDOWSKI PHONE NO : 714-961-6200
3150 EAST BIRCH ST. SE DECISION MADE: 27-APR-06
BREA, CA 92821 510(k) STATEMENT
DEVICE: VITELCARE C-TURTLE PATIENT MONITORING SYSTEM
VISUAL TELECOMMUNICATIONS NETWORK,510(k) NO: K060712(SPECIAL)
ATTN: ALLEN IZADPANAH PHONE NO : 703-448-0999
8201 GREENSBORO DR., STE. 600 SE DECISION MADE: 19-APR-06
MCLEAN, VA 22102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VYGON LEADER-FLEX
VYGON CORP. 510(k) NO: K052564(TRADITIONAL)
ATTN: COURTNEY SMITH PHONE NO : 610-539-9300
2495 GENERAL ARMISTEAD AVE SE DECISION MADE: 05-APR-06
NORRISTOWN, PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONSERVE PLUS QUADRAFIX ACETABULAR SHELL
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K060356(SPECIAL)
ATTN: MATT PAUL PHONE NO : 901-867-4350
5677 AIRLINE RD. SE DECISION MADE: 18-APR-06
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVOLVE MODULAR RADIAL HEAD
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K060731(SPECIAL)
ATTN: WESLEY L REED PHONE NO : 901-867-4701
5677 AIRLINE RD. SE DECISION MADE: 19-APR-06
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VECTRA LASER SYSTEM
XINTEC CORPORATION, DBA, 510(k) NO: K060114(TRADITIONAL)
ATTN: MARILYN M CHOU PHONE NO : 510-832-2130
1660 SOUTH LOOP ROAD SE DECISION MADE: 07-APR-06
ALAMEDA, CA 94502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYNESYS SPINAL SYSTEM WITH HA COATED SCREWS
ZIMMER SPINE, INC 510(k) NO: K060638(SPECIAL)
ATTN: TIM CRABTREE PHONE NO : 952-857-5631
7375 BUSH LAKE RD. SE DECISION MADE: 06-APR-06
MINNEAPOLIS, MN 55439-2027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXGEN KNEE GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENTS
ZIMMER, INC. 510(k) NO: K060370(TRADITIONAL)
ATTN: STEPHEN MCKELVEY PHONE NO : 574-372-4944
P.O. BOX 708 SE DECISION MADE: 28-APR-06
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIVERSAL LOCKING SYSTEM, 3.5MM PLATES AND SCREWS-4936 PLATES,48
ZIMMER, INC. 510(k) NO: K060710(TRADITIONAL)
ATTN: ANTHONY FRANCALANCIA PHONE NO : 574-372-4570
P.O. BOX 708 SE DECISION MADE: 26-APR-06
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 255
TOTAL WITH SUMMARIES 233
TOTAL WITH STATEMENTS 22
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