FDA 510(k) Applications for Medical Device:
Condom With Nonoxynol-9

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K972430 CUSTOM SERVICES INTL., INC. 3111 WEST POST RD.
LAS VEGAS NV 89118
K972429 CUSTOM SERVICES INTL., INC. 3111 WEST POST RD.
LAS VEGAS NV 89118
K970791 CUSTOM SERVICES INTL., INC. 3111 WEST POST RD.
LAS VEGAS NV 89118
K963322 CUSTOM SERVICES INTL., INC. 3111 WEST POST RD.
LAS VEGAS NV 89118
K990669 DONGKUK TECHCO RUBBER INDUSTRIES SDN. BHD. 7TH FL. MAYBAN TRUST BLDG.
PENANG 10200
K972836 G. PREMJEE (USA), INC. 55 NORTHER BLVD. SUITE 410
GREAT NECK NY 11021
K991047 HARDCOVER PRODUCTS, INC. 55 ADMINISTRATION RD., UNIT 12
CONCORD, ONTARIO L4K 4G9
K992438 INDUS MEDICARE LTD. 144, S.P. RD., BEGUMPET
HYDERABAD ANDHRA PRADESH 500 016
K010178 INNOLATEX SDN. BHD NO. 16, JALAN BULAN U5/5,
SHAH ALAM, SELANGOR D.E. 40150
K952415 LONDON INTERNATIONAL U.S. HOLDINGS, INC. 1819 MAIN ST., 8TH FLOOR
SARASOTA FL 34236
K953813 LONDON INTERNATIONAL U.S. HOLDINGS, INC. 1819 MAIN ST., 8TH FLOOR
SARASOTA FL 34236
K981955 LS RUBBER SDN BHD 11535 PARK WOODS CIRCLE
ALPHARETTA GA 30005
K012969 MEDTECH PRODUCTS LTD. S-59 20TH ST., ANNA NAGAR WEST
CHENNAI 600 040
K931220 MONSYS USA, INC. 116 NORTH MAIN ST.
PHILIPPI WV 26416
K001377 PLEASURE LATEX PRODUCTS SDN. BHD. LOT 1365, 17TH MILES, JALAN
JERAM, SELANGOR 45800
K974326 REDDY MEDTECH HEALTH PRODUCTS LTD. 9 WEBSTER COURT
PLAINSBORO NJ 08536
K974324 REDDY MEDTECH HEALTH PRODUCTS LTD. 9 WEBSTER COURT
PLAINSBORO NJ 08536
K033163 RICHARD VAN HAUSSEN AMERICA, INC. 5777 W. CENTURY BLVD.
LOS ANGELES CA 90045
K981621 SURETEX PROPHYLACTICS (INDIA) LTD. 74-91, KIADB INDUSTRIAL ESTATE
BANGALORE 562 106
K003375 TECNILATEX S.A. APDO. CORREOS, 156
MADRID 28923
K001978 THAI NIPPON RUBBER INDUSTRY CO., LTD. 1219 LITTLE CREEK RD.
DURHAM NC 27713




Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact