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 |
|
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