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Medical Devices
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April 2007 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-2007 THROUGH 30-APR-2007
DEVICE: ARGOS
3D LINE MEDICAL SYSTEMS S.R.L. 510(k) NO: K061479(TRADITIONAL)
ATTN: MARCO LUZZARA PHONE NO : 39 02 2550161
VIA BERNARDO RUCELLAI 23 SE DECISION MADE: 05-APR-07
MILAN, ITALY 20161 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: 3M TEGADERM CHG DRESSING
3M COMPANY 510(k) NO: K063458(TRADITIONAL)
ATTN: MARIA RUIZ PHONE NO : 651-736-2733
3M CENTER BUILDING 275-05W-06 SE DECISION MADE: 05-APR-07
ST. PAUL, MN 55144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MESODERM
AA ADVANCED TECHNOLOGY INC. 510(k) NO: K061849(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 888-729-9674
1676 VILLAGE GREEN SE DECISION MADE: 30-APR-07
CROFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM
ABBOTT DIABETES CARE INC. 510(k) NO: K070850(SPECIAL)
ATTN: DHRUMA SHAH PHONE NO : 510-749-5400
1360 SOUTH LOOP RD. SE DECISION MADE: 10-APR-07
ALAMEDA, CA 94502-7000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABBOTT ARCHITECT HAVAB-M
ABBOTT LABORATORIES 510(k) NO: K063329(ABBREVIATED)
ATTN: JOSEPH C ORLOWSKI PHONE NO : 847-938-6141
100 ABBOTT PARK RD. SE DECISION MADE: 16-APR-07
ABBOTT PARK, IL 60064-6095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SORBACT WOUND DRESSING
ABIGO MEDICAL AB 510(k) NO: K063059(TRADITIONAL)
ATTN: EMALEE G MURPHY PHONE NO : 202-778-9428
1601 K STREET NW SE DECISION MADE: 19-APR-07
WASHINGTON, DC 20006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: B-SCAN PLUS
ACCUTOME ULTRASOUND, INC. 510(k) NO: K070943(TRADITIONAL)
ATTN: JEFFREY WRIGHT PHONE NO : 610-889-0200
263 GREAT VALLEY PARKWAY SE DECISION MADE: 19-APR-07
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM
ACUMEN MEDICAL, INC. 510(k) NO: K070051(TRADITIONAL)
ATTN: MARYBETH GAMBER PHONE NO : 408-530-1810
275 SANTA ANA COURT SE DECISION MADE: 06-APR-07
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIAL CABLE, 3009
ADVANCED NEUROMODULATION SYSTEMS 510(k) NO: K070847(SPECIAL)
ATTN: PENNY HOUSTON PHONE NO : 972-309-8639
6901 PRESTON RD. SE DECISION MADE: 11-APR-07
PLANO, TX 75024 510(k) STATEMENT
DEVICE: N95 RESPIRATOR, MODELS N9504C, N9504CS AND N9514C
AEARO COMPANY 510(k) NO: K070168(ABBREVIATED)
ATTN: ANN L PHILLIPS PHONE NO : 508-764-5713
90 MECHANIC ST. SE DECISION MADE: 18-APR-07
SOUTHBRIDGE, MA 01550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AESCULAP RESORBABLE PIN, MODEL FR735
AESCULAP IMPLANT SYSTEM, INC. 510(k) NO: K070178(TRADITIONAL)
ATTN: MATTHEW M HULL PHONE NO : 610-984-9072
3773 CORPORATE PARKWAY SE DECISION MADE: 30-APR-07
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM
ALFA TECH MEDICAL SYSTEMS, LTD. 510(k) NO: K063728(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949-429-5825
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 04-APR-07
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRA
ALFA WASSERMANN, INC. 510(k) NO: K063306(TRADITIONAL)
ATTN: MURRAY ROSENTHAL, PHD PHONE NO : 973-852-0120
4 HENDERSON DR. SE DECISION MADE: 17-APR-07
WEST CALDWELL, NJ 07006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REVOLIX DUO LASER SYSTEM
ALLMED SYSTEMS INC. 510(k) NO: K070466(TRADITIONAL)
ATTN: PETER ALLEN PHONE NO : 925-468-0433
9232 KLEMETSON DRIVE SE DECISION MADE: 17-APR-07
PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCENT
ALMA LASERS LTD. 510(k) NO: K070004(TRADITIONAL)
ATTN: ANNE WORDEN PHONE NO : 925-895-1200
3637 BERNAL AVE. SE DECISION MADE: 23-APR-07
PLEASANTON, CA 94566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALTAIRE MPS#1 MULTIPURPOSE CONTACT LENS SOLUTION
ALTAIRE PHARMACEUTICALS, INC. 510(k) NO: K062332(TRADITIONAL)
ATTN: MARTIN DALSING PHONE NO : 970-243-5501
GRAND VALLEY BUSINESS PLAZA SE DECISION MADE: 25-APR-07
SUITE B7 510(k) SUMMARY AVAILABLE FROM FDA
GRAND JUNCTION, CO 81505
DEVICE: COMBI SCAN 500 URINE TEST STRIP ANALYZER, MODEL A93005
ANALYTICON BIOTECHNOLOGIES AG 510(k) NO: K061812(TRADITIONAL)
ATTN: KLAUS LANGER PHONE NO : 49 645 479910
AM MUEHLENBERG 10 SE DECISION MADE: 06-APR-07
LICHTENFELS, GERMANY 35104 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: COMBI SCAN100
ANALYTICON BIOTECHNOLOGIES AG 510(k) NO: K061846(TRADITIONAL)
ATTN: KLAUS LANGER PHONE NO : 49 645 479910
AM MUEHLENBERG 10 SE DECISION MADE: 06-APR-07
LICHTENFELS, HESSEN, GERMANY 35104510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: INVIVODENTAL
ANATOMAGE, INC 510(k) NO: K070803(TRADITIONAL)
ATTN: ROBERT J CHIN PHONE NO : 650-593-5225
111N. MARKET ST, STE 930 SE DECISION MADE: 06-APR-07
SAN JOSE, CA 95113 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: FILTERFLO HEPA; THERMOFLO HEPA (FILTER / HME)
ARC MEDICAL, INC. 510(k) NO: K063125(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239-498-2155
3460 POINTE CREEK COURT SE DECISION MADE: 13-APR-07
# 102 510(k) SUMMARY AVAILABLE FROM FDA
BONITA SPRINGS, FL 34134-2015
DEVICE: ARTHROCARE CAVITY SPINEWAND
ARTHROCARE CORP. 510(k) NO: K063172(TRADITIONAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-735-0224
680 VAQUEROS AVE. SE DECISION MADE: 27-APR-07
SUNNYVALE, CA 94085-3523 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPUS MAGNUM PI KNOTLESS FIXATION DEVICE
ARTHROCARE CORP. 510(k) NO: K070227(TRADITIONAL)
ATTN: LAURA N KASPEROWICZ PHONE NO : 949-585-2406
15285 ALTON PARKWAY SE DECISION MADE: 16-APR-07
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
IRVINE, CA 92618
DEVICE: ARTHROCARE ENT PLASMA WAND
ARTHROCARE CORP. 510(k) NO: K070374(TRADITIONAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-735-0224
680 VAQUEROS AVE. SE DECISION MADE: 25-APR-07
SUNNYVALE, CA 94085-3523 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPUS SMARTSTITCH SUTURE DEVICE
ARTHROCARE CORP. 510(k) NO: K070671(SPECIAL)
ATTN: LAURA N KASPEROWICZ PHONE NO : 949-585-2406
15285 ALTON PARKWAY, #200 SE DECISION MADE: 06-APR-07
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHROCARE SPINEWANDS
ARTHROCARE CORP. 510(k) NO: K070851(SPECIAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-736-0224
680 VAQUEROS AVE. SE DECISION MADE: 13-APR-07
SUNNYVALE, CA 94085-3523 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ARTHROCARE ARTHROWANDS
ARTHROCARE CORP. 510(k) NO: K070958(SPECIAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-736-0224
680 VAQUEROS AVE. SE DECISION MADE: 23-APR-07
SUNNYVALE, CA 94085-3523 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASC-12 PIEZOELECTRIC SCALER
ASEPTICO, INC. 510(k) NO: K070866(TRADITIONAL)
ATTN: GRANT RAMALEY PHONE NO : 425-487-3157
8333 216TH ST., S.E. SE DECISION MADE: 11-APR-07
WOODINVILLE, WA 98072 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: OSSEOSPEED 4.0S-6MM, MODEL 24619
ASTRA TECH, INC. 510(k) NO: K063779(TRADITIONAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235
11234 EL CAMINO REAL, STE 200 SE DECISION MADE: 27-APR-07
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM
AVANTIS MEDICAL SYSTEMS, INC. 510(k) NO: K070330(TRADITIONAL)
ATTN: SCOTT RUTHERFORD PHONE NO : 408-733-1901
263 SANTA ANA CT. SE DECISION MADE: 24-APR-07
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BODY-STIM, BIOMODULATOR, BEST-RSI, BEST PRO, MODEL BEST-AV1
AVAZZIA, INC. 510(k) NO: K062641(TRADITIONAL)
ATTN: CATHERINE TONE PHONE NO : 214-575-2820
13154 COIT RD., STE. 200 SE DECISION MADE: 30-APR-07
DALLAS, TX 75240 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROBLADE SHAVER AND ACCESSORIES
BAXANO, INC. 510(k) NO: K063231(TRADITIONAL)
ATTN: SHARON ROCKWELL PHONE NO : 714-779-1239
5582 CHALON ROAD SE DECISION MADE: 16-APR-07
YORBA LINDA, CA 92886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLLEAGUE GUARDIAN CONFIGURATION TOOL; COLLEAGUE DL2 EVENT HISTO
BAXTER HEALTHCARE CORP. 510(k) NO: K070125(TRADITIONAL)
ATTN: JEME WALLACE PHONE NO : 847-473-6273
1620 WAUKEGAN ROAD SE DECISION MADE: 16-APR-07
MCGAW PARK, IL 60085-6730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORBITAL RECONSTRUCTIVE IMPLANT
BECKER & ASSOCIATES CONSULTING INC510(k) NO: K070130(TRADITIONAL)
ATTN: CAMPBELL TUSKEY PHONE NO : 202-822-1850
2001 PENNSYLVANIA AVENUE NW SE DECISION MADE: 19-APR-07
SUITE 950 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20006
DEVICE: POWDERED LATEX SURGICAL GLOVE
BEIJING REAGENT LATEX PRODUCTS CO.510(k) NO: K062797(ABBREVIATED)
ATTN: RYAN BARR PHONE NO : 888-729-9674
1676 VILLAGE GREEN SE DECISION MADE: 11-APR-07
CROFTON, MD 21114 510(k) STATEMENT
DEVICE: LYPHOCHEK DIABETES CONTROL
BIO-RAD LABORATORIES 510(k) NO: K070546(TRADITIONAL)
ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285
9500 JERONIMO RD. SE DECISION MADE: 02-APR-07
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2
BIO-RAD, DIAGNOSTICS GRP. 510(k) NO: K070848(TRADITIONAL)
ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285
9500 JERONIMO RD. SE DECISION MADE: 25-APR-07
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIODUCT
BIODUCT, LLC 510(k) NO: K053492(TRADITIONAL)
ATTN: HERB SCHWARTZ PHONE NO : 260-407-6468
3201 STELLHORN ROAD SE DECISION MADE: 12-APR-07
FORT WAYNE, IN 46815 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYPERQ SYSTEM
BIOLOGICAL SIGNAL PROCESSING LTD. 510(k) NO: K070624(SPECIAL)
ATTN: GEORGE J HATTUB PHONE NO : 508-479-6116
291 HILLSIDE AVENUE SE DECISION MADE: 06-APR-07
SOMERSET, MA 02726 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOLUCENT APPLICATOR KIT
BIOLUCENT, INC. 510(k) NO: K070659(SPECIAL)
ATTN: DAVE CAMPBELL PHONE NO : 949-349-1380
6 JOURNEY, SUITE 325 SE DECISION MADE: 04-APR-07
ALISO VIEJO, CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECHO BI-METRIC PRESS-FIT STEMS
BIOMET MANUFACTURING CORP. 510(k) NO: K070274(SPECIAL)
ATTN: SUSAN ALEXANDER PHONE NO : 574-267-6639
PO BOX 587 SE DECISION MADE: 03-APR-07
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPINAL STABILIZING SPHERE SYSTEM
BIOMET SPINE 510(k) NO: K063139(TRADITIONAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 574-267-6639
P.O. BOX 587 SE DECISION MADE: 04-APR-07
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM
BIOSENSORS INTERNATIONAL-USA 510(k) NO: K070710(SPECIAL)
ATTN: SARA TOYLOY PHONE NO : 949-553-8300
20280 ACACIA ST., SUITE 300 SE DECISION MADE: 19-APR-07
NEWPORT BEACH, CA 92660 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STATIC CRANIOPLASTY ORTHOSIS
BOSTON BRACE INTL., INC. 510(k) NO: K063098(TRADITIONAL)
ATTN: JAMES WYNNE PHONE NO : 508-588-6060
20 LEDIN DR. SE DECISION MADE: 11-APR-07
AVON, MA 02322 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVE
BRAEMAR, INC. 510(k) NO: K071011(SPECIAL)
ATTN: DARREN DERSHEM PHONE NO : 651-286-8620
1285 CORPORATE CENTER DR. SE DECISION MADE: 27-APR-07
SUITE 150 510(k) STATEMENT
EAGAN, MN 55121
DEVICE: VV FLUORO 3D
BRAINLAB AG 510(k) NO: K070106(TRADITIONAL)
ATTN: RAINER BIRKENBACH PHONE NO : 49 89 9915680
KAPELLENSTRASSE 12 SE DECISION MADE: 23-APR-07
FELDKIRCHEN, GERMANY 85622 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWERGROSHONG PICC CATHETER
C.R. BARD, INC. 510(k) NO: K063848(TRADITIONAL)
ATTN: LYNN M KIRCHOFF PHONE NO : 801-595-0700
5425 WEST AMELIA EARHART DR. SE DECISION MADE: 04-APR-07
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARD MALECOT AND PEZZER DRAINS
C.R. BARD, INC. 510(k) NO: K070879(SPECIAL)
ATTN: JOHN KNORPP PHONE NO : 678-342-4920
13183 HARLAND DRIVE SE DECISION MADE: 24-APR-07
COVINGTON, GA 30014-6421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C.T.M. MOBILITY SCOOTER# HS-265
C.T.M. HOMECARE PRODUCT, INC. 510(k) NO: K070602(TRADITIONAL)
ATTN: LINDA J BOVARD PHONE NO : 541-345-5431
29611 SIMMONS ROAD SE DECISION MADE: 02-APR-07
EUGENE, OR 97405 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: BODYGUARD INFUSION SYSTEM
CAESAREA MEDICAL ELECTRONICS LTD. 510(k) NO: K070718(SPECIAL)
ATTN: SHLOMI DINES PHONE NO : 972 462 71737
16 SHACHAM STREET SE DECISION MADE: 13-APR-07
INDUSTRIAL PARK 510(k) STATEMENT
CAESAREA, ISRAEL 38900
DEVICE: OSTEOFIX BONE VOID FILLER
CALCITEC, INC 510(k) NO: K070220(TRADITIONAL)
ATTN: JANICE M HOGAN PHONE NO : 267-675-4611
1835 MARKET STREET, 28TH FLOOR SE DECISION MADE: 12-APR-07
PHILADELPHIA, PA 19103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASCENT UNIVERSAL ADHESIVE, MODEL 006-00028
CAO GROUP, INC. 510(k) NO: K070413(TRADITIONAL)
ATTN: ROBERT K LARSEN PHONE NO : 801-256-9282
4628 WEST SKYHAWK DRIVE SE DECISION MADE: 26-APR-07
WEST JORDAN, UT 84084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COAXIAL BONE AND VERTEBRAL BODY BIOPSY NEEDLE MODEL# JBC1213, JB
CARDINAL HEALTH, INC. 510(k) NO: K070091(TRADITIONAL)
ATTN: SHARON NICHOLS PHONE NO : 847-578-6610
1430 WAUKEGAN ROAD- MPKB-3B SE DECISION MADE: 18-APR-07
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIOMEMS ENDOSURE S2 14F WIRELESS AAA PRESSURE MEASUREMENT SYS
CARDIOMEMS, INC. 510(k) NO: K070680(SPECIAL)
ATTN: GRACE POWERS PHONE NO : 404-920-6719
75 FIFTH ST., NW SE DECISION MADE: 05-APR-07
SUITE 440 510(k) SUMMARY AVAILABLE FROM FDA
ATLANTA, GA 30308
DEVICE: ZIRBLOCK
CDL TECHNOLOGIES INC. 510(k) NO: K070537(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854
PO BOX 7007 SE DECISION MADE: 30-APR-07
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XPERT MRSA
CEPHEID 510(k) NO: K070462(TRADITIONAL)
ATTN: RUSSEL K ENNS PHONE NO : 408-400-8230
904 CARIBBEAN DRIVE SE DECISION MADE: 17-APR-07
SUNNYVALE, CA 94089-1189 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO AQUADEX FLEXFLOW SYSTEM
CHF SOLUTIONS, INC. 510(k) NO: K070512(SPECIAL)
ATTN: CHRIS SCAVOTTO PHONE NO : 763-463-4621
7601 NORTHLAND DR. STE. 170 SE DECISION MADE: 27-APR-07
BROOKLYN PARK, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHILI PACS
CHILI GMBH 510(k) NO: K070796(TRADITIONAL)
ATTN: UWE ENGELMANN PHONE NO : 49 622 11807910
BURGSTRASSE 61 SE DECISION MADE: 06-APR-07
HEIDELBERG, BW, GERMANY 69121 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PARKINSENSE, MODEL PS-2400
CLEVELAND MEDICAL DEVICES, INC. 510(k) NO: K063872(TRADITIONAL)
ATTN: JOSEPH GIUFFRIDA PHONE NO : 216-791-6720
4415 EUCLID AVE SE DECISION MADE: 06-APR-07
CLEVELAND, OH 44103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXICLIP EXCS-M
CLEVEX INC. 510(k) NO: K070836(TRADITIONAL)
ATTN: LENA SATTLER PHONE NO : 440-554-3706
9996 CARROUSEL CT SE DECISION MADE: 20-APR-07
LOVELAND, OH 45140 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFIED MERCY RETRIEVER, MODEL 90070
CONCENTRIC MEDICAL, INC. 510(k) NO: K070521(SPECIAL)
ATTN: KIRSTEN VALLEY PHONE NO : 650-810-1707
1380 SHOREBIRD WAY SE DECISION MADE: 24-APR-07
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONMED LINVATEC SMART GUARD IRRIGATOR
CONMED LINVATEC 510(k) NO: K070233(SPECIAL)
ATTN: ELIZABETH M PAUL PHONE NO : 727-399-5234
11311 CONCEPT BOULEVARD SE DECISION MADE: 02-APR-07
LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AQUACEL HYDROFIBER DRESSING AND AQUACEL AG WITH HYDROFIBER SILVE
CONVATEC, A DIVISION OF E.R. SQUIB510(k) NO: K063271(TRADITIONAL)
ATTN: MARILYN KONICKY PHONE NO : 908-904-2541
200 HEADQUARTERS PARK DR. SE DECISION MADE: 16-APR-07
SKILLMAN, NJ 08558 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIS FACIAL CYLINDER, SIS FACIAL IMPLANT
COOK BIOTECH, INC. 510(k) NO: K070738(SPECIAL)
ATTN: MARY A FADERAN PHONE NO : 765-497-3355
1425 INNOVATION PLACE SE DECISION MADE: 05-APR-07
WEST LAFAYETTE, IN 47906 510(k) STATEMENT
DEVICE: COOK MICROWIRE WIRE GUIDE
COOK, INC. 510(k) NO: K070410(SPECIAL)
ATTN: KAREN BRADBURN PHONE NO : 812-339-2235
P.O. BOX 489 SE DECISION MADE: 27-APR-07
BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORIN UNIPOLAR MODULAR HEAD
CORIN USA 510(k) NO: K063791(TRADITIONAL)
ATTN: KATHY K TRIER PHONE NO : 813-977-4469
10500 UNIVERSITY CENTER DRIVE SE DECISION MADE: 03-APR-07
SUITE 190 510(k) SUMMARY AVAILABLE FROM FDA
TAMPA, FL 33612
DEVICE: NANO COMPOSITE
COSMEDENT, INC. 510(k) NO: K070583(TRADITIONAL)
ATTN: JAMES L SANDRIK PHONE NO : 312-644-9586
401 NORTH MICHIGAN AVE. SE DECISION MADE: 16-APR-07
SUITE 2500 510(k) SUMMARY AVAILABLE FROM FDA
CHICAGO, IL 60611
DEVICE: DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR)
DADE BEHRING, INC. 510(k) NO: K070552(TRADITIONAL)
ATTN: LORRAINE H PIESTRAK PHONE NO : 302-631-6279
P.O. BOX 6101 SE DECISION MADE: 30-APR-07
MS 514 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714
DEVICE: EASY CURING PEN-STYLE LED CURING LIGHT
DENT CORP. RESEARCH & DEVELOPMENT 510(k) NO: K063659(TRADITIONAL)
ATTN: DAVID ALBELDA PHONE NO : 914-682-6600
7-11 SOUTH BROADWAY SE DECISION MADE: 30-APR-07
WHITE PLAINS, NY 10601 510(k) STATEMENT
DEVICE: EXPEDIUM SFX CROSS CONNECTOR SYSTEM
DEPUY SPINE, INC. 510(k) NO: K070300(SPECIAL)
ATTN: CHRISTOPHER KLACZYK PHONE NO : 508-828-2852
325 PARAMOUNT DR. SE DECISION MADE: 10-APR-07
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASY CHECK BLOOD GLUCOSE MONITORING SYSTEM
DIACARE CORP. 510(k) NO: K062538(TRADITIONAL)
ATTN: SID MATHUR PHONE NO : 516-482-9001
55 NORTHERN BLVD. SE DECISION MADE: 30-APR-07
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: LIAISON BORRELIA IGG/IGM ASSAY, MODEL 310870; SERUM CONTROLS, MO
DIASORIN, INC. 510(k) NO: K062473(TRADITIONAL)
ATTN: CAROL A DEPOUW PHONE NO : 651-351-5850
1951 NORTHWESTERN AVE. SE DECISION MADE: 12-APR-07
P.O. BOX 285 510(k) SUMMARY AVAILABLE FROM FDA
STILLWATER, MN 55082
DEVICE: DIAZYME CREATININE LIQUID REAGENTS ASSAY
DIAZYME LABORATORIES 510(k) NO: K062105(TRADITIONAL)
ATTN: ABHIJIT DATTA PHONE NO : 858-455-4762
3550 GENERAL ATOMICS CT. SE DECISION MADE: 23-APR-07
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A
DIAZYME LABORATORIES 510(k) NO: K070734(SPECIAL)
ATTN: ABHIJIT DATTA PHONE NO : 858-455-4762
3550 GENERAL ATOMICS CT. SE DECISION MADE: 09-APR-07
SAN DIEGO, CA 92121 510(k) STATEMENT
DEVICE: GLOBUS PREMIUM MUSCLE STIMULATOR
DOMINO S.R.L. 510(k) NO: K061632(TRADITIONAL)
ATTN: GIOVANNI CIRIANI PHONE NO : 860-561-9509
18 EUSTACE DRIVE SE DECISION MADE: 30-APR-07
WEST HARTFORD, CT 06110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DENTAL DIGITAL PANORAMIC/3D IMAGING SYSTEM
E-WOO TECHNOLOGY 510(k) NO: K070658(TRADITIONAL)
ATTN: STEPHEN T MLCOCH PHONE NO : 631-744-0059
30 NORTHPORT ROAD SE DECISION MADE: 05-APR-07
SOUND BEACH, NY 11789 510(k) STATEMENT
DEVICE: EMPOWERMR INJECTOR SYSTEM, MODEL 9730
E-Z-EM, INC. 510(k) NO: K062449(ABBREVIATED)
ATTN: ROBERT WILLIAMS PHONE NO : 516-333-8230
750 SUMMA AVE. SE DECISION MADE: 13-APR-07
WESTBURY, NY 11590 510(k) STATEMENT
DEVICE: PRO OSTEON 500R
EBI, L.P. 510(k) NO: K063346(TRADITIONAL)
ATTN: DEBRA BING PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 18-APR-07
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FMP METAL/METAL ACETABULAR INSERT, 499-28,449-34, 499-38
ENCORE MEDICAL, L.P. 510(k) NO: K070221(TRADITIONAL)
ATTN: TEFFANY HUTTO PHONE NO : 512-834-6225
9800 METRIC BLVD. SE DECISION MADE: 04-APR-07
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM
ENDIUS, INC. 510(k) NO: K070367(TRADITIONAL)
ATTN: CHRISTINE KUNTZ-NASSIF PHONE NO : 508-643-0983
23 WEST BACON ST. SE DECISION MADE: 12-APR-07
PLAINVILLE, MA 02762 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TALKING TRACH
ENGINEERED MEDICAL SYSTEMS, INC. 510(k) NO: K062104(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239-498-2155
3460 POINTE CREEK SE DECISION MADE: 20-APR-07
# 102 510(k) SUMMARY AVAILABLE FROM FDA
BONITA SPRINGS, FL 34134-2015
DEVICE: EP-WORKMATE
EP MEDSYSTEMS 510(k) NO: K070706(SPECIAL)
ATTN: LARRY PICCIANO PHONE NO : 856-753-8533
COOPER RUN EXECUTIVE PARK SE DECISION MADE: 11-APR-07
575 ROUTE 73 N. BLDG. D 510(k) SUMMARY AVAILABLE FROM FDA
WEST BERLIN, NJ 08091
DEVICE: ULTRAPRO PLUG
ETHICON, INC. 510(k) NO: K070224(TRADITIONAL)
ATTN: BRYAN A LISA PHONE NO : 908-218-3392
U.S. ROUTE 22, WEST SE DECISION MADE: 17-APR-07
P.O. BOX 151 510(k) SUMMARY AVAILABLE FROM FDA
SOMERVILLE, NJ 08876-0151
DEVICE: FRESENIUS RENAL ACUTE CARE (RAC 100) FILTER, MODEL 0500610N
FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K070222(TRADITIONAL)
ATTN: JANET C KAY PHONE NO : 781-402-4475
920 WINTER STREET SE DECISION MADE: 24-APR-07
WALTHAM, MA 02451-1457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GC MI PASTE PLUS
GC AMERICA, INC. 510(k) NO: K070854(SPECIAL)
ATTN: TERRY L JORITZ-LYONS PHONE NO : 708-926-3105
3737 WEST 127TH ST. SE DECISION MADE: 12-APR-07
ALSIP, IL 60803 510(k) STATEMENT
DEVICE: UNIVERSAL SURGICAL MESH, MODEL 100
GENERIC MEDICAL DEVICE, INC. 510(k) NO: K070018(TRADITIONAL)
ATTN: MONICA R MONTANEZ PHONE NO : 713-523-9630
3906 ROSELAND ST. SE DECISION MADE: 27-APR-07
HOUSTON, TX 77006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEON, MODELS GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4
GENOSS CO., LTD. 510(k) NO: K062834(ABBREVIATED)
ATTN: KLASS BESSELING PHONE NO : 949-466-7472
28711 JAEGER DRIVE SE DECISION MADE: 24-APR-07
LAGUNA NIGUEL, CA 92677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER
GETINGE SOURCING LLC 510(k) NO: K070657(SPECIAL)
ATTN: ANN WHEELER PHONE NO : 585-272-5036
1777 EAST HENRIETTA RD. SE DECISION MADE: 05-APR-07
ROCHESTER, NY 14623-3133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: PROVIDENCE ANTERIOR CERVICAL PLATE SYSTEM
GLOBUS MEDICAL INC. 510(k) NO: K070775(SPECIAL)
ATTN: KELLY J BAKER PHONE NO : 610-415-9000
2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 19-APR-07
AUDUBON, PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H,
GOOD BIOTECH CORP. 510(k) NO: K063766(TRADITIONAL)
ATTN: VICTOR CHIOU PHONE NO : 886 423 596873
38, 34TH RD. SE DECISION MADE: 23-APR-07
TAICHUNG INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
TAICHUNG, CHINA (TAIWAN) 407
DEVICE: MEISINGER BENEX, MODEL BE001
HAGER & MEISINGER GMBH 510(k) NO: K062130(TRADITIONAL)
ATTN: ALEX MILLER PHONE NO : 303-268-5400
7442 S. TUCSON WAY SUITE 130 SE DECISION MADE: 16-APR-07
CENTENNIAL, CO 80112 510(k) STATEMENT
DEVICE: ZILOS-TK
HAMILTON THORNE BIOSCIENCES 510(k) NO: K063636(TRADITIONAL)
ATTN: DOUGLAS HAMILTON PHONE NO : 978-921-2050
100 CUMMINGS CENTER, SE DECISION MADE: 24-APR-07
SUITE 465E 510(k) SUMMARY AVAILABLE FROM FDA
BEVERLY, MA 01915
DEVICE: ECHOSTIM FACET TIP
HAVEL'S, INC. 510(k) NO: K063380(TRADITIONAL)
ATTN: PATRICK CARROTHERS PHONE NO : 513-271-2117
3726 LONSDALE ST. SE DECISION MADE: 25-APR-07
CINCINNATI, OH 45227 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S33
HEARTWAY MEDICAL PRODUCTS CO., LTD510(k) NO: K071007(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 352 08829
NO.58, FU-CHIUN ST. SE DECISION MADE: 19-APR-07
HSIN-CHU CITY, CHINA (TAIWAN) 408 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRAUMARREST AND BLEEDARREST HEMOSTATIC PARTICLES AND FOAM
HEMOSTASIS, LLC 510(k) NO: K070211(TRADITIONAL)
ATTN: KEITH ROBERTS PHONE NO : 651-402-7705
5000 TOWNSHIP PARKWAY SE DECISION MADE: 05-APR-07
ST. PAUL, MN 55110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLAS
HORIBA ABX 510(k) NO: K070249(TRADITIONAL)
ATTN: PASCAL MACZIOLA PHONE NO : 334 671 41503
PARC EUROMEDECINE SE DECISION MADE: 26-APR-07
RUE DU CADUCEE 510(k) SUMMARY AVAILABLE FROM FDA
MONTPELLIER, HERAULT, FRANCE 34184
DEVICE: HOSPIRA PLUM A+ INFUSION PUMP, MODEL 12391
HOSPIRA, INC. 510(k) NO: K070398(SPECIAL)
ATTN: NICOHL R WILDING PHONE NO : 224-212-5270
275 NORTH FIELD DR. SE DECISION MADE: 24-APR-07
LAKE FOREST, IL 60045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMEGA 3 SUPRACONDYLAR PLATE
HOWMEDICA OSTEONICS CORP 510(k) NO: K070454(SPECIAL)
ATTN: FRANCISCO HARO PHONE NO : 201-831-5493
325 CORPORATE DR. SE DECISION MADE: 12-APR-07
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HSINER NEBULIZER BOTTLE
HSINER 510(k) NO: K070948(SPECIAL)
ATTN: TOM SHANKS PHONE NO : 951-506-2674
29201 VIA NORTE SE DECISION MADE: 25-APR-07
TEMECULA, CA 92591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYE MANAGEMENT SYSTEM
ICU MEDICAL, INC 510(k) NO: K063784(SPECIAL)
ATTN: MARTIN MAIER PHONE NO : 801-264-1384
4455 ATHERTON DR. SE DECISION MADE: 16-APR-07
SALT LAKE CITY, UT 84123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMC HEARTWAY, LLC ELECTRIC POWERED WHEELCHAIR, MODEL ALLURE (HP6
IMC-HEARTWAY, LLC 510(k) NO: K063328(TRADITIONAL)
ATTN: MICHAEL CHEN PHONE NO : 239-275-6767
13050 METRO PARKWAY SE DECISION MADE: 27-APR-07
BAY 5 510(k) STATEMENT
FORT MYERS, FL 33966
DEVICE: OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE
IMPLANT INNOVATIONS, INC. 510(k) NO: K063286(TRADITIONAL)
ATTN: JACQUELYN A HUGHES PHONE NO : 561-776-6819
4555 RIVERSIDE DR. SE DECISION MADE: 24-APR-07
PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3I OSSEOTITE CERTAIN DENTAL IMPLANTS
IMPLANT INNOVATIONS, INC. 510(k) NO: K063341(TRADITIONAL)
ATTN: JACQUELYN A HUGHES PHONE NO : 561-776-6819
4555 RIVERSIDE DR. SE DECISION MADE: 30-APR-07
PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANTLIA II SUCTION PUMP SYSTEM
INNOVATIVE THERAPIES, INC. 510(k) NO: K070904(TRADITIONAL)
ATTN: JUDITH HARBOUR PHONE NO : 864-200-0412
11 VENDUE COURT SE DECISION MADE: 13-APR-07
SIMPSONVILLE, SC 29681 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: INOMAX DS (DELIVERY SYSTEM), MODEL 10003
INO THERAPEUTICS LLC 510(k) NO: K070867(SPECIAL)
ATTN: RICHARD K BOURNE PHONE NO : 908-238-6312
6 ROUTE 173 SE DECISION MADE: 27-APR-07
CLINTON, NJ 08809 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTA LITE SS-A 52 ELISA
INOVA DIAGNOSTICS, INC. 510(k) NO: K063565(TRADITIONAL)
ATTN: BRYS C MYERS PHONE NO : 858-586-9900
9900 OLD GROVE RD. SE DECISION MADE: 04-APR-07
SAN DIEGO, CA 92131-1638 510(k) STATEMENT
DEVICE: QUANTA LITE RNA POL III ELISA
INOVA DIAGNOSTICS, INC. 510(k) NO: K070066(TRADITIONAL)
ATTN: BRYS C MYERS PHONE NO : 858-586-9900
9900 OLD GROVE RD. SE DECISION MADE: 11-APR-07
SAN DIEGO, CA 92131-1638 510(k) STATEMENT
DEVICE: AUDICOR 200 SYSTEM, MODELS 200D AND 200S
INOVISE MEDICAL, INC. 510(k) NO: K070136(TRADITIONAL)
ATTN: STEVE HESLER PHONE NO : 503-431-3800
10565 SW NIMBUS AVE. SE DECISION MADE: 13-APR-07
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
PORTLAND, OR 97223
DEVICE: FOAM RING PORT PROTECTOR
INSPIRED IDEAS, INCORPORATED 510(k) NO: K062261(TRADITIONAL)
ATTN: ALLISON SCOTT PHONE NO : 317-569-9500
11460 N. MERIDIAN STREET SE DECISION MADE: 09-APR-07
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
CARMEL, IN 46032
DEVICE: TWILIGHT FULL FACE MASK
INVACARE CORP. 510(k) NO: K070321(TRADITIONAL)
ATTN: CARROLL MARTIN PHONE NO : 440-329-6356
ONE INVACARE WAY SE DECISION MADE: 30-APR-07
ELYRIA, OH 44035-4190 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INVIROSNAP SAFETY SYRINGE, MODELS 120006, 120007, 120008, 100080
INVIRO MEDICAL DEVICES, INC. 510(k) NO: K070203(SPECIAL)
ATTN: JIM BARLEY PHONE NO : 770-291-2186
3235 SATELLITE BLVD. SE DECISION MADE: 23-APR-07
BLDG. 400, STE. 300 510(k) SUMMARY AVAILABLE FROM FDA
DULUTH, GA 30096
DEVICE: FLEXITRON
ISODOSE CONTROL B.V. 510(k) NO: K070574(ABBREVIATED)
ATTN: HUB VAN DE BERGH PHONE NO : 310 318 502950
LANDJUWEEL 11 SE DECISION MADE: 13-APR-07
VEENENDAAL, NETHERLANDS 3905 PE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INQU
ISTO TECHNOLOGIES, INC. 510(k) NO: K063359(TRADITIONAL)
ATTN: GARY GAGE PHONE NO : 301-652-5344
1155 OLIVETTE EXEC. PKWY. SE DECISION MADE: 16-APR-07
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
ST. LOUIS, MO 63132
DEVICE: JMS PLANECTA STOPCOCK
JMS NORTH AMERICA CORP. 510(k) NO: K070143(TRADITIONAL)
ATTN: CHONG SWEE CHEAU PHONE NO : 510-888-9090
22320 FOOTHILL BLVD., SE DECISION MADE: 10-APR-07
SUITE 350 510(k) SUMMARY AVAILABLE FROM FDA
HAYWARD, CA 94541
DEVICE: RMI LCD ALCOHOL DETECTOR
KAMM & ASSOCIATES 510(k) NO: K062545(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854
P.O. BOX 7007 SE DECISION MADE: 09-APR-07
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISIO+CD VIEWER# KPSCDVE01
KEOSYS S.A.S. 510(k) NO: K070606(TRADITIONAL)
ATTN: ANTHONY MOTTIER PHONE NO : 003 302 40922613
IMPASSE AUGUSTIN FRESNEL, SE DECISION MADE: 24-APR-07
Z.A. DU MOULIN NEUF 510(k) SUMMARY AVAILABLE FROM FDA
SAINT-HERBLAIN, FRANCE 44815
DEVICE: KINGLY STAR POWERED MUSCLE STIMULATOR, MODEL KS-138
KINGLY STAR INTL. TECHNOLOGY CO., 510(k) NO: K062453(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO 58, FU-CHIUN ST SE DECISION MADE: 17-APR-07
HSIN-CHU CIY, CHINA 30067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURY
KIRWAN SURGICAL PRODUCTS, INC. 510(k) NO: K060915(TRADITIONAL)
ATTN: KEVIN P PRARIO PHONE NO :
180 ENTERPRISE DRIVE SE DECISION MADE: 17-APR-07
MARSHFIELD, MA 02050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISCYPHOR CATHETER SYSTEM, MODEL D01A; DISCYPHOR INTRODUCER NEED
KYPHON, INC. 510(k) NO: K063071(SPECIAL)
ATTN: CINDY DOMECUS PHONE NO : 408-548-5421
1221 CROSSMAN AVE. SE DECISION MADE: 13-APR-07
SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CVS PERSONAL LUBRICANT AND MOISTURIZER
LAKE CONSUMER PRODUCTS, INC. 510(k) NO: K062682(TRADITIONAL)
ATTN: MARY L WUNDROCK PHONE NO : 262-677-4121
1 PHARMACAL WAY SE DECISION MADE: 04-APR-07
JACKSON, WI 53037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDILASER, MODEL 1000
LASER THERA, LLC 510(k) NO: K063745(TRADITIONAL)
ATTN: SHELLY HENRY PHONE NO : 888-502-9955
5300 N. MERIDIAN, SUITE 1 SE DECISION MADE: 23-APR-07
OKLAHOMA CITY, OK 73112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: VELSCOPE
LED DENTAL INC. 510(k) NO: K070523(TRADITIONAL)
ATTN: DAVID C MORGAN, PHD PHONE NO : 604-541-4614
#201-15047 MARINE DR. SE DECISION MADE: 05-APR-07
WHITE ROCK, BRITISH COLUMBIA, CANA510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEONE MONOIMPLANT FOR O-RING OVERDENTURE
LEONE SPA 510(k) NO: K070483(TRADITIONAL)
ATTN: ELIA LADANI PHONE NO : 39 055 30441
50, VIA P. A QUARACCHI SE DECISION MADE: 19-APR-07
SESTO, FLORENTINO, ITALY I-50019 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LERADOTECH, MODEL SC
LERADO CHINA LIMITED 510(k) NO: K070802(TRADITIONAL)
ATTN: JUNNATA CHANG PHONE NO : 886 4 22465396
14F-2, NO. 1, ZHUANGJING RD. SE DECISION MADE: 13-APR-07
LANE 25 510(k) SUMMARY AVAILABLE FROM FDA
BANQIAO, TAIPEI COUNTY, CHINA (TAIWAN)
DEVICE: LERADOTECH SCOOTER, MODEL SB
LERADO CHINA LIMITED 510(k) NO: K070817(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 13-APR-07
HSIN-CHU CITY, CHINA (TAIWAN) 3006510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LINDE INTEGRATED VALVE (LIV)
LINDE GAS THERAPEUTICS 510(k) NO: K063354(TRADITIONAL)
ATTN: JAMES J ROGERS PHONE NO : 440-546-4936
P.O. BOX 470218 SE DECISION MADE: 17-APR-07
BROADVIEW HEIGHTS, OH 44147 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWERED NITRILE BLUE EXAMINATION GLOVES
LIWE TRADING 510(k) NO: K061505(TRADITIONAL)
ATTN: K M LEE PHONE NO : 033 392 1992
49,JALAN SS 2/19 SE DECISION MADE: 09-APR-07
47300 PETALING JAYA 510(k) STATEMENT
SELANGOR DARUL EHSAN, MALAYSIA 47300
DEVICE: MISTRAL - ONE STAGE SCREW-TYPE DENTAL IMPLANT, MODEL MF9
M.I.S. IMPLANTS TECHNOLOGIES LTD. 510(k) NO: K070022(SPECIAL)
ATTN: MOTTI WEISMAN PHONE NO : 201-797-9144
278 BROADWAY SE DECISION MADE: 20-APR-07
ELMWOOD PARK, NJ 07407 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KNIGHTCONTROL REMOTE CONTROL, MODEL M-114700-US
MALLINCKRODT DEVELOPPEMENT FRANCE 510(k) NO: K063501(TRADITIONAL)
ATTN: JAMES BONDS PHONE NO : 925-463-4371
4280 HACIENDA DR. SE DECISION MADE: 06-APR-07
PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION
MALLINCKRODT INC., LIEBEL-FLARSHEI510(k) NO: K063503(SPECIAL)
ATTN: DALE MOORE PHONE NO : 513-948-5771
2111 EAST GALBRAITH RD. SE DECISION MADE: 27-APR-07
CINCINNATI, OH 45237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDIAID DISPOSABLE NON-ADHESIVE SENSORS, MODEL CST050-2101N; REU
MEDIAID INC. 510(k) NO: K061896(TRADITIONAL)
ATTN: MAHESH PATEL PHONE NO : 714-367-2848
17517 FABRICA WAY #H SE DECISION MADE: 12-APR-07
CERRITOS, CA 90703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPRESS SERIES
MEDICAL GRAPHICS CORP. 510(k) NO: K070858(SPECIAL)
ATTN: MARY E DONLIN PHONE NO : 651-766-3305
350 OAK GROVE PKWY. SE DECISION MADE: 16-APR-07
ST. PAUL, MN 55127-8599 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMS MULTI GLUCOSE CONTROL, MODEL 2120049
MEDICAL SPECIALTIES SUPPLY CO., IN510(k) NO: K070506(TRADITIONAL)
ATTN: JOHN C GORMLEY PHONE NO : 830-372-1391
1755 EAST BIRCHWOOD AVE. SE DECISION MADE: 18-APR-07
DES PLAINES, IL 60018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDISIZE GOLD HEATER AND BOOSTER
MEDISIZE BV 510(k) NO: K070714(TRADITIONAL)
ATTN: SOPHIA LAM PHONE NO : 31 252 576888
EDISONSTRAAT 1 SE DECISION MADE: 30-APR-07
HILLEGOM, NETHERLANDS 2181 AB 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM
MEDISON CO., LTD. 510(k) NO: K070813(TRADITIONAL)
ATTN: KYUNG-AM SHIM PHONE NO : 822 219 41381
1003, DAECHI-DONG SE DECISION MADE: 10-APR-07
GANGNANM-GU 510(k) SUMMARY AVAILABLE FROM FDA
SEOUL, REPUBLIC OF KOREA 135-280 THIRD PARTY REVIEW
DEVICE: THE FUGO BLADE FOR DENTISTRY
MEDISURG LTD. 510(k) NO: K063468(TRADITIONAL)
ATTN: RICHARD J FUGO PHONE NO : 610-277-3937
100 WEST FORNANCE ST. SE DECISION MADE: 18-APR-07
THE FUGO BUILDING 510(k) SUMMARY AVAILABLE FROM FDA
NORRISTOWN, PA 19401
DEVICE: MEROGEL INJECTABLE BIORESORBABLE STENT
MEDTRONIC INC. 510(k) NO: K070886(TRADITIONAL)
ATTN: JAYME WILSON PHONE NO : 904-296-9600
6743 SOUTHPOINT DRIVE NORTH SE DECISION MADE: 26-APR-07
JACKSONVILLE, FL 32259 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE, MODELS 49260 AND 49
MEDTRONIC, INC. 510(k) NO: K070311(TRADITIONAL)
ATTN: DEBBIE KIDDER PHONE NO : 763-391-9251
7601 NORTHLAND DRIVE SE DECISION MADE: 24-APR-07
MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: RESCUE INTERNAL IMPLANT SYSTEM
MEGAGEN CO., LTD. 510(k) NO: K063216(TRADITIONAL)
ATTN: SUN HAHM PHONE NO : 562-404-8466
13340 E. FIRESTONE BLVD. SE DECISION MADE: 02-APR-07
SUITE J 510(k) SUMMARY AVAILABLE FROM FDA
SANTA FE SPRINGS, CA 90670
DEVICE: HORIZON SE
MENNEN MEDICAL LTD. 510(k) NO: K070254(TRADITIONAL)
ATTN: MICHA OESTEREICH PHONE NO : 972 893 23333
4 HAYARDEN ST. SE DECISION MADE: 19-APR-07
P.O. BOX 102 REHOVOT 510(k) SUMMARY AVAILABLE FROM FDA
YAVNE, ISRAEL 76100
DEVICE: BLUE SHARK
MERIDAN MEDICAL 510(k) NO: K070016(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 02-APR-07
IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WIRELESS TEMPERATURE MONITOR / MODELS ST323C AND ST323F.
MESURE TECHNOLOGY CO.,LTD. 510(k) NO: K063542(TRADITIONAL)
ATTN: JOHN CHEN PHONE NO : 886 285 122747
7F,86, SEC.1,KWANG FU ROAD SE DECISION MADE: 10-APR-07
SANCHUNG CITY, TAIPEI HSIEN, CHINA510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL CLINICAL THERMOMETER/MODELS ST8C SERIES
MESURE TECHNOLOGY CO.,LTD. 510(k) NO: K071019(SPECIAL)
ATTN: JOHN CHEN PHONE NO : 886 285 122747
7F, 88, SEC. 1, KWANG FU ROAD SE DECISION MADE: 27-APR-07
SAN CHUNG CITY 510(k) STATEMENT
TAIPEI HSIEN, CHINA (TAIWAN) R.O.C.
DEVICE: FX DETACHABLE COIL SYSTEM
MICRO THERAPEUTICS, INC. 510(k) NO: K060747(TRADITIONAL)
ATTN: FLORIN TRUUVERT PHONE NO : 949-837-3700
2 GOODYEAR SE DECISION MADE: 24-APR-07
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICRUS MICROCOIL SYSTEM
MICRUS ENDOVASCULAR CORPORATION 510(k) NO: K070707(SPECIAL)
ATTN: PATRICK LEE PHONE NO : 408-433-1428
821 FOX LANE SE DECISION MADE: 06-APR-07
SAN JOSE, CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINI LAP PEDIATRIC INSTRUMENTS WITH MEDUSA CLAMPING SYSTEM
MINI LAP TECHNOLOGIES INC. 510(k) NO: K070352(TRADITIONAL)
ATTN: JOSEPH AZARY PHONE NO : 203-944-9320
543 LONG HILL AVE. SE DECISION MADE: 05-APR-07
SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINI LAP INSTRUMENTS
MINI LAP TECHNOLOGIES INC. 510(k) NO: K070686(TRADITIONAL)
ATTN: JOSEPH AZARY PHONE NO : 203-944-9320
543 LONG HILL AVE. SE DECISION MADE: 05-APR-07
SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLUE POWDERED LATEX EXAMINATION GLOVES, NON-STERILE
MULTISAFE SDN BHD 510(k) NO: K062526(TRADITIONAL)
ATTN: ABD HADI BIN HUSIN PHONE NO : 605 434 826972
LOT 764 SE DECISION MADE: 13-APR-07
BIDOR INDUSTRIAL ESTATE 510(k) SUMMARY AVAILABLE FROM FDA
BIDOR, PERAK, MALAYSIA 35500
DEVICE: MYOMO E100
MYOMO, INC. 510(k) NO: K062631(TRADITIONAL)
ATTN: KATE ZEBROSE PHONE NO : 617-996-9058
529 MAIN STREET SE DECISION MADE: 12-APR-07
SUITE 205 510(k) SUMMARY AVAILABLE FROM FDA
BOSTON, MA 02129
DEVICE: NEOCOIL 3.0T 6-CHANNEL CAROTID ARRAY COIL
NEOCOIL 510(k) NO: K070778(TRADITIONAL)
ATTN: BRIAN BROWN PHONE NO : 262-347-1250
N27 W23910A PAUL RD. SE DECISION MADE: 11-APR-07
PEWAUKEE, WI 53072 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CES ULTRA
NEURO-FITNESS LLC 510(k) NO: K062284(TRADITIONAL)
ATTN: MICHAEL STEVENS PHONE NO : 425-222-0830
P.O. BOX 1031 SE DECISION MADE: 05-APR-07
SNOQUALMIE, WA 98065 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEWLIFE SCIENCES LLC, MODEL TMR
NEWLIFE SCIENCES, LLC 510(k) NO: K070474(TRADITIONAL)
ATTN: RONALD WEINSTOCK PHONE NO : 603-429-3022
51 PONDVIEW DR. SE DECISION MADE: 25-APR-07
MERRIMACK, NH 03054-4162 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ORION
NIDEK TECHNOLOGIES SRL 510(k) NO: K070231(TRADITIONAL)
ATTN: ALDO COCCHIGLIA PHONE NO : 39 049 8629200
VIA DELL ARTIGIANATO, 6/A SE DECISION MADE: 24-APR-07
ALBIGNASEGO (PADOVA), ITALY 35020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZYGOMA IMPLANT (IMMEDIATE FUNCTION)
NOBEL BIOCARE AB 510(k) NO: K070182(TRADITIONAL)
ATTN: HERBERT CRANE PHONE NO : 714-282-5074
22715 SAVI RANCH PARKWAY SE DECISION MADE: 04-APR-07
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO NUVASIVE LATERAL PLATE SYSTEM
NUVASIVE, INC. 510(k) NO: K070273(SPECIAL)
ATTN: LAETITIA COUSIN PHONE NO : 858-909-1868
4545 TOWNE CENTRE CT. SE DECISION MADE: 03-APR-07
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DICOMPACS, MODEL 5
OEHM UND REHBEIN GMBH 510(k) NO: K070618(TRADITIONAL)
ATTN: FRANZISKA GUNTHER PHONE NO : 493 812 0361291
WALDEMSRSTR. 20G/H SE DECISION MADE: 25-APR-07
ROCKSTOCK, GERMANY 18057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM
OHMEDA MEDICAL 510(k) NO: K070210(TRADITIONAL)
ATTN: AGATA SMIEJA PHONE NO : 410-888-5218
8880 GORMAN RD. SE DECISION MADE: 20-APR-07
LAUREL, MD 20723 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM
OHMEDA MEDICAL 510(k) NO: K070247(TRADITIONAL)
ATTN: AGATA SMIEJA PHONE NO : 410-888-5218
8880 GORMAN RD. SE DECISION MADE: 20-APR-07
LAUREL, MD 20723 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPUS URIC ACID REAGENT, MODEL OSR6X98
OLYMPUS AMERICA, INC. 510(k) NO: K062862(TRADITIONAL)
ATTN: BEV HARDING PHONE NO : 972-556-9697
3131 WEST ROYAL LN. SE DECISION MADE: 06-APR-07
IRVING, TX 75063-3104 510(k) STATEMENT
DEVICE: CYRTINA SYSTEM
ORATIO B.V. 510(k) NO: K063842(TRADITIONAL)
ATTN: JEF M VAN DER ZEL PHONE NO : 31 229 247660
COLE PORTERHOF 168 SE DECISION MADE: 17-APR-07
HOORN, NETHERLANDS 1628TN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CA
ORTHO-CLINICAL DIAGNOSTICS 510(k) NO: K063720(TRADITIONAL)
ATTN: SARAH CV PARSONS PHONE NO : 585-453-3154
100 INDIGO CREEK DR. SE DECISION MADE: 09-APR-07
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KRYSTAL-X WIFI
OWANDY 510(k) NO: K070505(TRADITIONAL)
ATTN: CLAUDE BERTHOIN PHONE NO : 800-323-2690
110 EAST GRANADA BLVD SE DECISION MADE: 05-APR-07
SUITE 207 510(k) SUMMARY AVAILABLE FROM FDA
ORMOND BEACH, FL 32176
DEVICE: DELTACUT (APPARATUS AND CANNULA)
PAJUNK GMBH MEDIZINTECHNOLOGIE 510(k) NO: K063233(TRADITIONAL)
ATTN: CHRISTIAN QUASS PHONE NO : 497 704 9291 X 586
KARL-HALL-STRASSE 01 SE DECISION MADE: 30-APR-07
GEISINGEN, BADEN-WURTTEMBERG, GERM510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYPER SAL
PARI INNOVATIVE MANUFACTURERS, INC510(k) NO: K070498(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239-498-2155
3460 POINTE CREEK CT. #102 SE DECISION MADE: 26-APR-07
BONITA SPRINGS, FL 34134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SE
PHILIPS MEDICAL SYSTEMS, INC. 510(k) NO: K063783(SPECIAL)
ATTN: TAPAN D SHAH PHONE NO : 978-659-7681
3000 MINUTEMAN RD. SE DECISION MADE: 27-APR-07
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QLAB QUANTIFICATION
PHILIPS ULTRASOUND, INC. 510(k) NO: K070792(TRADITIONAL)
ATTN: LYNN HARMER PHONE NO : 425-487-7312
22100 BOTHELL EVERETT HWY. SE DECISION MADE: 06-APR-07
P.O. BOX 3003 510(k) SUMMARY AVAILABLE FROM FDA
BOTHELL, WA 98041 THIRD PARTY REVIEW
DEVICE: SIMPLEX CERVICAL FIXATION SYSTEM
PISHARODI SURGICALS, INC. 510(k) NO: K070335(SPECIAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD. SE DECISION MADE: 16-APR-07
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PL
PLAYTEX PRODUCTS, INC. 510(k) NO: K070745(SPECIAL)
ATTN: KEITH EDGETT PHONE NO : 302-678-6000
804 WALKER RD. SE DECISION MADE: 13-APR-07
DOVER, DE 19904 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLARCUP DUAL MOBILITY SYSTEM
PLUS ORTHOPEDICS AG 510(k) NO: K070278(TRADITIONAL)
ATTN: PAMELA J WEAGRAFF PHONE NO : 508-528-1745
18 BRIDIE LANE SE DECISION MADE: 16-APR-07
NORFOLK, MA 02056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTI-ANALYTE CHEMISTRY CALIBRATOR
POINTE SCIENTIFIC, INC. 510(k) NO: K070207(ABBREVIATED)
ATTN: RON JAMISON PHONE NO : 734-487-8300
5449 RESEARCH DRIVE SE DECISION MADE: 13-APR-07
CANTON, MI 48188 510(k) STATEMENT
DEVICE: CARBON DIOXIDE LIQUID STABLE REAGENT
POINTE SCIENTIFIC, INC. 510(k) NO: K070251(TRADITIONAL)
ATTN: WILLIAM F WALTERS, JR PHONE NO : 734-487-8300
5449 RESEARCH DRIVE SE DECISION MADE: 30-APR-07
CANTON, MI 48188 510(k) STATEMENT
DEVICE: AMMONIA/ALCOHOL CONTROL SET
POINTE SCIENTIFIC, INC. 510(k) NO: K070504(ABBREVIATED)
ATTN: RON JAMISON PHONE NO : 734-487-8300
5449 RESEARCH DRIVE SE DECISION MADE: 11-APR-07
CANTON, MI 48188 510(k) STATEMENT
DEVICE: HEALTH MASK
POLAR WRAP LLC 510(k) NO: K070467(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239-498-2155
3460 POINTE CREEK COURT #102 SE DECISION MADE: 17-APR-07
BONITA SPRINGS, FL 34134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFT CHAIR, MODEL C5
PRIDE MOBILITY PRODUCTS CORP. 510(k) NO: K070950(SPECIAL)
ATTN: THOMAS J SCHAPPERT PHONE NO : 570-655-5574
182 SUSQUEHANNA AVE. SE DECISION MADE: 16-APR-07
EXETER, PA 18643 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROGENY IMAGING SOFTWARE, MODEL# 500-405 (6,7,8).
PROGENY, INC. 510(k) NO: K070664(TRADITIONAL)
ATTN: ALAN KREMA PHONE NO : 847-850-3800
1407 BARCLAY BLVD. SE DECISION MADE: 26-APR-07
BUFFALO GROVE, IL 60089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERILOX LIQUID CHEMICAL STERILANT SYSTEM
PURICORE, INC. 510(k) NO: K063159(TRADITIONAL)
ATTN: HOWARD MANN PHONE NO : 610-341-1899
320 KING OF PRUSSIA ROAD SE DECISION MADE: 02-APR-07
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
RADNOR, PA 19087
DEVICE: FASTPACK TOTAL PSA METHOD VERIFICATION KIT
QUALIGEN, INC. 510(k) NO: K062957(ABBREVIATED)
ATTN: MELISSA SAAM PHONE NO : 760-918-9165
2042 CORTE DEL NOGAL SE DECISION MADE: 02-APR-07
CARLSBAD, CA 92011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUPRA OPHTHALMIC LASER PHOTOCOAGULATOR
QUANTEL MEDICAL 510(k) NO: K070776(SPECIAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377 ROUTE 17 SOUTH SE DECISION MADE: 24-APR-07
HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUICK VUE RSV TEST, MODELS 20193, 20199
QUIDEL CORP. 510(k) NO: K070747(TRADITIONAL)
ATTN: JENNIFER HANKARD PHONE NO : 858-552-7910
10165 MCKELLAR CT. SE DECISION MADE: 23-APR-07
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHAROS EXCIMER LASER SYSTEM, MODEL EX-308
RA MEDICAL SYSTEMS, INC. 510(k) NO: K062963(TRADITIONAL)
ATTN: DEAN IRWIN PHONE NO : 760-804-1648
2270 CAMINO VIDA ROBLE SE DECISION MADE: 03-APR-07
SUITE L 510(k) SUMMARY AVAILABLE FROM FDA
CARLSBAD, CA 92011
DEVICE: RII INFRARED EAR THERMOMETER, MODEL TH01BN
RADIANT INNOVATION INC. 510(k) NO: K070976(SPECIAL)
ATTN: FRANK LIN PHONE NO : 886 361 11666
1F, NO. 3 INDUSTRIAL E. 9TH RD SE DECISION MADE: 20-APR-07
SCIENCE-BASED INDUSTRIAL PARK, 510(k) SUMMARY AVAILABLE FROM FDA
HSIN CHU, CHINA (TAIWAN)
DEVICE: PATIENTGALLERY IMAGING SOFTWARE
RASTER BUILDERS, INC. 510(k) NO: K070954(TRADITIONAL)
ATTN: DAVID L STARK PHONE NO : 415-888-3700
38 MILLER AVE. SE DECISION MADE: 20-APR-07
PMB 170 510(k) SUMMARY AVAILABLE FROM FDA
MILL VALLEY, CA 94941 THIRD PARTY REVIEW
DEVICE: INTERSON USB ULTRASOUND PROBE SYSTEM
REGULATORY MANAGEMENT SERVICES 510(k) NO: K070907(TRADITIONAL)
ATTN: GARY J ALLSEBROOK PHONE NO : 510-388-5001
16303 PANORAMIC WAY SE DECISION MADE: 17-APR-07
SAN LEANDRO, CA 94578 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: FRAXEL III SR LASER SYSTEM AND ACCESSORIES
RELIANT TECHNOLOGIES, INC. 510(k) NO: K063038(TRADITIONAL)
ATTN: HEATHER TANNER MACFALLS PHONE NO : 650-641-5861
464 ELLIS ST. SE DECISION MADE: 27-APR-07
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FRAXEL IV SR LASER SYSTEM
RELIANT TECHNOLOGIES, INC. 510(k) NO: K063808(TRADITIONAL)
ATTN: HEATHER TANNER MACFALLS PHONE NO : 650-605-2257
464 ELLIS ST. SE DECISION MADE: 27-APR-07
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INCIRCLE BI-POLAR RF ABLATION SYSTEM
RFA MEDICAL, INC. 510(k) NO: K070711(TRADITIONAL)
ATTN: NANCY LINCE PHONE NO : 650-759-6186
40874 CALIDO PLACE SE DECISION MADE: 24-APR-07
FREMONT, CA 94539 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ELECSYS CORTISOL TEST SYSTEM
ROCHE DIAGNOSTICS 510(k) NO: K070788(SPECIAL)
ATTN: KAY TAYLOR PHONE NO : 317-521-3544
9115 HAGUE RD. SE DECISION MADE: 20-APR-07
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
ROCHE DIAGNOSTICS CORPORATION 510(k) NO: K070172(TRADITIONAL)
ATTN: THERESA AMBROSE BUSH PHONE NO : 317-521-3723
9115 HAGUE ROAD SE DECISION MADE: 17-APR-07
INDIANAPOLIS, IN 46256 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR
ROCHE DIAGNOSTICS CORPORATION 510(k) NO: K070174(TRADITIONAL)
ATTN: THERESA AMBROSE BUSH PHONE NO : 317-521-3723
9115 HAGUE ROAD SE DECISION MADE: 16-APR-07
INDIANAPOLIS, IN 46256 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RS-4I MUSCLE STIMULATOR FAMILY
RS MEDICAL 510(k) NO: K062325(TRADITIONAL)
ATTN: STEVEN CHERNOFF PHONE NO : 425-861-8262
P.O. BOX 3515 SE DECISION MADE: 13-APR-07
REDMOND, WA 98073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERPLATE VBR SYSTEM
RSB SPINE LLC. 510(k) NO: K070316(TRADITIONAL)
ATTN: KAREN E WARDEN PHONE NO : 440-729-8457
8202 SHERMAN ROAD SE DECISION MADE: 19-APR-07
CHESTERLAND, OH 44026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAPHENEIA CLARITY
SAPHENEIA COMMERCIAL PRODUCTS AB 510(k) NO: K063391(TRADITIONAL)
ATTN: RICK MANCILLA PHONE NO : 877-268-9342
932 NORTH STATE STREET SE DECISION MADE: 26-APR-07
JACKSON, MS 39202-2613 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-REC
SARMED SRL 510(k) NO: K062362(TRADITIONAL)
ATTN: ANTONIO ROSSETTI PHONE NO : 003 905 3551159
VIA DEGLI ARTIGIANI, 6 SE DECISION MADE: 13-APR-07
MEDOLLA, ITALY 41036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DGSCOPE, RELEASE 1.0
SEGAMI CORPORATION 510(k) NO: K070397(TRADITIONAL)
ATTN: PHILIPPE BRIANDET PHONE NO : 410-381-2311
8325-B GUILFORD ROAD SE DECISION MADE: 13-APR-07
COLUMBIA, MD 21046 510(k) STATEMENT
DEVICE: MIRAGE CEDARS OPTION
SEGAMI CORPORATION 510(k) NO: K070683(SPECIAL)
ATTN: PHILIPPE BRIANDET PHONE NO : 410-381-2311
8325 GUILFORD RD., SUITE B SE DECISION MADE: 12-APR-07
COLUMBIA, MD 21046 510(k) STATEMENT
DEVICE: TEXTURED POWDER FREE NITRILE EXAM GLOVES WITH SAP
SHEN WEI (USA), INC. 510(k) NO: K061756(TRADITIONAL)
ATTN: CYNTHIA LIU PHONE NO : 510-429-8692
33278 CENTRAL AVE., SE DECISION MADE: 19-APR-07
SUITE 102 510(k) STATEMENT
UNION CITY, CA 94587
DEVICE: HYPERVISOR VI CENTRAL MONITORING SYSTEM
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K062194(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 11-APR-07
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.
SINTEA BIOTECH, INC. 510(k) NO: K070181(TRADITIONAL)
ATTN: GUSTAVO A RIOS PHONE NO : 305-673-6226
407 LINCOLN RD. SUITE 10L SE DECISION MADE: 18-APR-07
MIAMI BEACH, FL 33139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOBUTTON DIRECT
SMITH & NEPHEW INC., ENDOSCOPY DIV510(k) NO: K070167(TRADITIONAL)
ATTN: DEANA BOUSHELL PHONE NO : 508-337-4036
150 MINUTEMAN RD. SE DECISION MADE: 12-APR-07
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMS GLUCOSE CONTROL, MODEL 2120061
SPECTRUM MEDICAL SUPPLY, INC. 510(k) NO: K070649(TRADITIONAL)
ATTN: JOHN C GORMLEY PHONE NO : 830-372-1391
940 CROSSROADS BLVD SE DECISION MADE: 12-APR-07
SEGUIN, TX 78155 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO STAXX FX SYSTEM
SPINE WAVE, INC. 510(k) NO: K063606(TRADITIONAL)
ATTN: RONALD K SMITH PHONE NO : 203-944-9494
TWO ENTERPRISE DR. SE DECISION MADE: 13-APR-07
SUITE 302 510(k) SUMMARY AVAILABLE FROM FDA
SHELTON, CT 06484
DEVICE: CAPSURE PEDICLE SCREW SYSTEM
SPINE WAVE, INC. 510(k) NO: K070245(TRADITIONAL)
ATTN: RONALD K SMITH PHONE NO : 203-944-9494
TWO ENTERPRISE DR. SE DECISION MADE: 05-APR-07
SUITE 302 510(k) SUMMARY AVAILABLE FROM FDA
SHELTON, CT 06484
DEVICE: KOREBALANCE (KINESTHETIC ABILITY TRAINER)
SPORTKAT, LLC 510(k) NO: K070676(SPECIAL)
ATTN: DAMON R LAWSON PHONE NO : 858-866-3393
1497 POINSETTIA AVE. STE. 157 SE DECISION MADE: 18-APR-07
VISTA, CA 92083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRADA CAROTID GUIDING SHEATH
ST. JUDE MEDICAL 510(k) NO: K070166(TRADITIONAL)
ATTN: JEFF STURM PHONE NO : 763-463-5713
6550 WEDGWOOD RD. NORTH SE DECISION MADE: 06-APR-07
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
MAPLE GROVE, MN 55311
DEVICE: POD B-SCAN
STARFISH PRODUCT ENGINEERING INC. 510(k) NO: K070884(TRADITIONAL)
ATTN: DAYRL WISDAHL PHONE NO : 250 388 3537
#5-555 ARDERSIER ROAD SE DECISION MADE: 11-APR-07
VICTORIA, B.C.,, CANADA V8Z 1C8 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: STARION UNIVERSAL POWER SUPPLY
STARION INSTRUMENTS 510(k) NO: K070871(SPECIAL)
ATTN: BRIAN GRIGSBY PHONE NO : 408-522-5200
775 PALOMAR AVENUE SE DECISION MADE: 13-APR-07
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRAUMANN COMPUTER AIDED RESTORATION SERVICE (C.A.R.E.S.) CERAMI
STRAUMANN USA 510(k) NO: K061277(TRADITIONAL)
ATTN: ELAINE ALAN PHONE NO : 800-448-8168
60 MINUTETEMAN ROAD SE DECISION MADE: 12-APR-07
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER TWIST DRILLS
STRYKER CRANIOMAXILLOFACIAL 510(k) NO: K070876(TRADITIONAL)
ATTN: TENNILLE FOLK PHONE NO : 877-534-2464
750 TRADE CENTRE WAY SE DECISION MADE: 27-APR-07
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
KALAMAZOO, MI 49002
DEVICE: ENSEAL PTC TISSUE SEALING DEVICE
SURGRX, INC. 510(k) NO: K070896(SPECIAL)
ATTN: LINDA OLESON PHONE NO : 650-482-2400
101 SAGINAW DR. SE DECISION MADE: 24-APR-07
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WILLSON ONE-FIT FLAT-FOLD HEALTHCARE PARTICULATE RESPIRATOR AND
SURVIVAIR RESPIRATORS, LLC 510(k) NO: K070782(ABBREVIATED)
ATTN: RICHARD O WOOD PHONE NO : 847-234-7500
1025 W. EVERETT RD. SE DECISION MADE: 11-APR-07
LAKE FOREST, IL 60045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM
SYNTHES (USA) 510(k) NO: K063790(TRADITIONAL)
ATTN: DEBORAH L JACKSON PHONE NO : 610-719-6948
1301 GOSHEN PKWY SE DECISION MADE: 16-APR-07
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNFIX -LR
SYNTHES SPINE CO.LP 510(k) NO: K062083(TRADITIONAL)
ATTN: BONNIE J SMITH PHONE NO : 610-719-5725
1302 WRIGHTS LANE EAST SE DECISION MADE: 03-APR-07
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELIBRA DYNAMIC KNEE BALANCER
SYNVASIVE TECHNOLOGY, INC. 510(k) NO: K070108(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854
P.O. BOX 7007 SE DECISION MADE: 04-APR-07
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 4S SPINAL SYSTEM
TAE YEON MEDICAL CO., LTD 510(k) NO: K063708(TRADITIONAL)
ATTN: GIL WOON CHOI PHONE NO : 823 223 57375
204, NAMDONG INDUSTRIAL SE DECISION MADE: 24-APR-07
COMPLEX, 45B-6L,# 435-6, N 510(k) SUMMARY AVAILABLE FROM FDA
INCHEON, REPUBLIC OF KOREA 405-848
DEVICE: ADVOCATE DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K070641(SPECIAL)
ATTN: ERICA LI PHONE NO : 886 266 358080
4F, NO. 88, SEC.1, KWANG-FU RD SE DECISION MADE: 09-APR-07
SAN-CHUNG 510(k) STATEMENT
TAIPEI COUNTY, CHINA (TAIWAN) 241
DEVICE: TECO HOMOCYSTEINE ENZYMATIC ASSAY
TECO DIAGNOSTICS 510(k) NO: K063701(TRADITIONAL)
ATTN: JIAN VAECHES PHONE NO : 714-693-7788
1268 NORTH LAKEVIEW AVE. SE DECISION MADE: 11-APR-07
ANAHEIM, CA 92807 510(k) STATEMENT
DEVICE: ODONCER
TEKNIMED SA 510(k) NO: K062102(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD SE DECISION MADE: 16-APR-07
ROUNDROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHONCHA THERM NEPTUNE HEATED HUMIFIER, CHONCHA THERM NEPTUNE HEA
TELEFLEX MEDICAL 510(k) NO: K063758(TRADITIONAL)
ATTN: LORI HAYS PHONE NO : 847-572-8027
2345 WAUKEGAN ROAD SE DECISION MADE: 23-APR-07
BANNOCKBURN, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORCE FIBER BLACK CO-BRAID POLYETHYLENE NON-ABSORBABLE SURGICAL
TELEFLEX MEDICAL, INC. 510(k) NO: K070673(SPECIAL)
ATTN: ELIZABETH LANDON PHONE NO : 919-361-3927
2917 WECK DR. SE DECISION MADE: 02-APR-07
RESEARCH TRIANGLE PARK, NC 27709 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEPHAFLEX SURGICAL MESH
TEPHA, INC. 510(k) NO: K070894(TRADITIONAL)
ATTN: MARY P LEGRAW PHONE NO : 617-995-5409
840 MEMORIAL DRIVE SE DECISION MADE: 13-APR-07
3RD FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
CAMBRIDGE, MA 02139
DEVICE: MODIFICATION TO CAPIOX FLEXIBLE VENOUS RESERVOIR
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K070839(SPECIAL)
ATTN: GARRY COURTNEY PHONE NO : 800-283-7866
125 BLUE BALL RD. SE DECISION MADE: 24-APR-07
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RUNTHROUGH NS
TERUMO MEDICAL CORP. 510(k) NO: K063695(SPECIAL)
ATTN: MARK UNTERREINER PHONE NO : 410-392-7213
950 ELKTON BLVD. SE DECISION MADE: 27-APR-07
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THEKEN VU MESH VBR SYSTEM
THEKEN SPINE LLC 510(k) NO: K070381(TRADITIONAL)
ATTN: DALE DAVISON PHONE NO : 330-773-7677
283 E WATERLOO RD. SE DECISION MADE: 25-APR-07
AKRON, OH 44319 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPI VECTODRILL CERAMIC DRILLS
THOMMEN MEDICAL, AG 510(k) NO: K070290(TRADITIONAL)
ATTN: FLOYD LARSON PHONE NO : 858-792-1235
11234 EL CAMINO REAL, STE. 200 SE DECISION MADE: 17-APR-07
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDILOGAR4, MEDILOGAR12
TOM MEDICAL ENTWICKLUNGS GMBH 510(k) NO: K070818(TRADITIONAL)
ATTN: THOMAS HASIBA PHONE NO : 433 162 616090
ANZENGRUBERGASSE 8 SE DECISION MADE: 06-APR-07
GRAZ, AUSTRIA A-8010 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: C!
TRANSPHOTON CORPORATION 510(k) NO: K070589(TRADITIONAL)
ATTN: BRANT WIGGER PHONE NO : 305-234-0836
14350 S.W. 142ND AVE. SE DECISION MADE: 24-APR-07
MIAMI, FL 33186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLOW-VU
TRUDELL MEDICAL INTL. 510(k) NO: K070674(SPECIAL)
ATTN: JOHN STRAATMAN PHONE NO : 519 455 4547
725 THIRD ST. SE DECISION MADE: 11-APR-07
LONDON, ONTARIO, CANADA N5V 5G4 510(k) STATEMENT
DEVICE: PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SET
UNOMEDICAL A/S 510(k) NO: K070430(TRADITIONAL)
ATTN: JOHN M LINDSKOG PHONE NO : 454 642 7810
AAHOLMVEJ 1-3, OSTED SE DECISION MADE: 04-APR-07
ROSKILDE, DENMARK DK-4000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VAPOTHERM MODEL# 2000I AND 2000H
VAPOTHERM, INC. 510(k) NO: K070056(SPECIAL)
ATTN: JOHNATHAN KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, NW SE DECISION MADE: 13-APR-07
WASHINGTON, DC 21666 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XY COR SPINAL IMPLANT FOR MINIMAL INVASIVE SPINAL SURGERY
VERTEBRATION,INC 510(k) NO: K070082(TRADITIONAL)
ATTN: BARBARA S FANT, PHARM.D. PHONE NO : 513-961-8200
310 TERRACE AVENUE, SUITE 201 SE DECISION MADE: 20-APR-07
CINCINNATI, OH 45220 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERTIFLEX OCTANE PEEK VERTEBRAL BODY REPLACEMENT (PEEK VBR)
VERTIFLEX (TM), INCORPORATED 510(k) NO: K070218(TRADITIONAL)
ATTN: STEVE REITZLER PHONE NO : 760-448-4800
1954 KELLOGG AVENUE, SUITE 100 SE DECISION MADE: 06-APR-07
CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900
VIASYS MEDSYSTEMS 510(k) NO: K063061(TRADITIONAL)
ATTN: STEPHANIE WASIELEWSKI PHONE NO : 847-403-3484
100 CHADDICK DR. SE DECISION MADE: 02-APR-07
WHEELING, IL 60090 510(k) STATEMENT
DEVICE: RETROPAN CCD-TWAIN-USB
VIDEO DENTAL CONCEPTS, INC. 510(k) NO: K070535(TRADITIONAL)
ATTN: CLAUDE BERTHOIN PHONE NO : 800-323-2690
110 E. GRANADA BLVD., STE. 207 SE DECISION MADE: 24-APR-07
ORMOND BEACH, FL 32175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLUOROPRO RF DIGITAL IMAGING SYSTEM
VIRTUAL IMAGING, INC. 510(k) NO: K070390(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854
PO BOX 7007 SE DECISION MADE: 05-APR-07
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUTRALENE POLYPROPYLENE SUTURES
VISIONARY MEDICAL SUPPLIES, INC. 510(k) NO: K070243(ABBREVIATED)
ATTN: GARY SYRING PHONE NO : 608-877-2635
800 LEVANGER LN. SE DECISION MADE: 17-APR-07
STOUGHTON, WI 53589 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL FOR CIRCULAR
W. L. GORE & ASSOCIATES, INC. 510(k) NO: K070644(SPECIAL)
ATTN: BARBARA L SMITH PHONE NO : 410-506-8189
301 AIRPORT RD. SE DECISION MADE: 02-APR-07
P.O. BOX 1408 510(k) SUMMARY AVAILABLE FROM FDA
ELKTON, MD 21922-1408
DEVICE: PRESSX ZR
WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K070772(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : 490 723 13705219
SCHWENNINGER STRABE 13 SE DECISION MADE: 30-APR-07
PFORZHEIM, GERMANY D-75179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COOK CELECT VENA CAVA FILTER
WILLIAM COOK EUROPE APS 510(k) NO: K061815(TRADITIONAL)
ATTN: THALIA BRINE PHONE NO : 812-339-2235
750 DANIELS WAY SE DECISION MADE: 20-APR-07
P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA
BLOOMINGTON, IN 47402-0489
DEVICE: WU'S POWERED WHEELCHAIR, MAMBO 36
WU'S TECH CO., LTD. 510(k) NO: K070655(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 02-APR-07
HSIN-CHU CITY, CHINA (TAIWAN) ROC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRIME PROTECTION POWDERED VINYL EXAMINATION GLOVES
ZHANGJIAGANG HUAYUAN PLASTIC CO., 510(k) NO: K070519(TRADITIONAL)
ATTN: Y. T YEO PHONE NO : 86 512 58416682
INDUSTRIAL CONCENTRATION SE DECISION MADE: 10-APR-07
DISTRICT TANGQIAO 510(k) STATEMENT
ZHANGJIAGANG CITY, JIANGSU, CHINA 215615
DEVICE: FREEALGIN
ZHERMACK S.P.A. 510(k) NO: K070700(TRADITIONAL)
ATTN: GERALD W SHIPPS PHONE NO : 541-389-5935
19379 BLUE LAKE LOOP SE DECISION MADE: 25-APR-07
BEND, OR 97702 510(k) STATEMENT
DEVICE: DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS
ZIMMER GMBH 510(k) NO: K070292(TRADITIONAL)
ATTN: ANTHONY FRANCALANCIA PHONE NO : 574-372-4570
PO BOX 708 SE DECISION MADE: 26-APR-07
WARSAW, IN 46581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER CUT RESISTANT GLOVE LINER, XSMALL, SMALL, MEDIUM, LARGE,
ZIMMER, INC. 510(k) NO: K063582(TRADITIONAL)
ATTN: CINDY J DICKEY PHONE NO : 330-364-9493
200 WEST OHIO AVENUE SE DECISION MADE: 26-APR-07
P.O. BOX 10 510(k) SUMMARY AVAILABLE FROM FDA
DOVER, OH 44622-0010
DEVICE: ZOLL E SERIES WITH SEE-THRU CPR
ZOLL MEDICAL CORPORATION, WORLD WI510(k) NO: K070455(SPECIAL)
ATTN: EILEEN M BOYLE PHONE NO : 978-421-9171
269 MILL ROAD SE DECISION MADE: 26-APR-07
CHELMSFORD, MA 01824-4105 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 243
TOTAL WITH SUMMARIES 213
TOTAL WITH STATEMENTS 30
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