Device Classification Name |
Condom
|
510(k) Number |
K902804 |
Device Name |
EXTEND STABILITY DATE FOR CONDOM W/SPERM LUBRICANT |
Applicant |
OKAMOTO U.S.A., INC. |
JEFFREY N. GIBBS, SUITE 600 |
1120 VERMONT AVENUE, N.W. |
WASHINGTON,
DC
20005
|
|
Applicant Contact |
& GIBBS |
Correspondent |
OKAMOTO U.S.A., INC. |
JEFFREY N. GIBBS, SUITE 600 |
1120 VERMONT AVENUE, N.W. |
WASHINGTON,
DC
20005
|
|
Correspondent Contact |
& GIBBS |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 06/27/1990 |
Decision Date | 08/13/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|