FDA 510(k) Applications for Medical Device:
Media, Electroconductive

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K161654 Carol Cole Company 1325 Sycamore Avenue, Suite A
Vista CA 92081
K944599 CHESTER LABS, INC. 1900 SECTION RD., SUITE A
CINCINNATI OH 45237
K944598 CHESTER LABS, INC. 1900 SECTION RD., SUITE A
CINCINNATI OH 45237
K001705 CHESTER LABS, INC. 1900 SECTION RD., SUITE A
CINCINNATI OH 45237
K033052 COMPUMEDICS USA, LTD. 7850 PASEO DEL NORTE
EL PASO TX 79912
K964737 D.O. WEAVER CO. 565-C NUCLA WAY
AURORA CO 80011
K962681 ECO-MED PHARMACEUTICALS, INC. 6155 TOMKEN ROAD
MISSISSAUGA, ONTARIO L4W 1H3
K111717 ELECTRO-CAP INTL., INC. 1011 WEST LEXINGTON RD.
EATON OH 45320
K161715 EndyMed Medical Ltd. 12 Leshem Street, North Industrial Park
Caesarea 3088900
K955597 GRAPHIC CONTROLS CORP. 189 VAN RENSSELAER ST.
BUAFFLO NY 14240-1271
K200402 Guangzhou Xinbo Electronic Co., Ltd. 23 Building, Phase-II, Huachuang Industry Park, Panyu,
Guangzhou 511450
K030887 INMED LTDA. 1308 MORNINGSIDE PARK DR.
ALPHARETTA GA 30022
K003924 MAVIDON MEDICAL PRODUCTS 2105 7TH AVE. NO.
LAKE WORTH FL 33461
K191975 Nihon Kohden Corporation 1-31-4 Nishiochiai, Shinjuku-ku
Tokyo 161-8560
K970694 PHYSIOMETRIX, INC. FIVE BILLERICA PARK,
NORTH BILLERICA MA 01862
K220735 Premier North America Inc. 3301 SW 42nd Street
Fort Lauderdale FL 33312-6828
K032239 PRIZM MEDICAL, INC. 111 LAUREL RIDGE DRIVE
ALPHARETTA GA 30004
K022494 ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY 2064 TAMARIN DR.
COLUMBUS OH 43235
K002832 SKYLARK DEVICE & SYSTEMS CO., LTD 34 CHUNG SHAN NORTH RD.,
TAIPEI
K983964 SKYLARK DEVICE CO., LTD. 34 CHUNG SHAN NORTH RD.,
TAIPEI
K212325 SOMNOmedics GmbH Am Sonnenstuhl 63
Randersacker 97236
K212326 Spes Medica S.r.l Via Europa-Zona industriale
Battipaglia 84091
K192606 Spes Medica S.r.l. Via Europa - zona industriale
Battipaglia (SA) 84091
K190050 Spes Medica S.r.l. Via Europa - zona industriale
Battipaglia (SA) 84091
K022006 THE DEZAC GROUP 719 A ST. NE
WASHINGTON DC 20002
K221724 Tone-A-Matic International Inc. 145 Traders East
Mississauga L5Z-3L3
K222770 Top-Rank Health Care Co.,Ltd. Mashan Village, Dongguan Street, Shangyu District
Shaoxing 312300
K212787 Wuhan Greentek Pty Ltd. Room 03-2, Floor 3, Dingye Building, Phase III,
Wuhan 430074




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