Device Classification Name |
condom
|
510(k) Number |
K893217 |
Device Name |
LATEX PROPHYLACTIC/RUBBER CONTRACEPTIVE |
Applicant |
SHINHEN CORP. |
CHUNG K. KWAK |
3350 WILSHIRE BLVD., #378 |
LOS ANGELES,
CA
90010
|
|
Applicant Contact |
BNF ENTERPRISES |
Correspondent |
SHINHEN CORP. |
CHUNG K. KWAK |
3350 WILSHIRE BLVD., #378 |
LOS ANGELES,
CA
90010
|
|
Correspondent Contact |
BNF ENTERPRISES |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 04/27/1989 |
Decision Date | 01/10/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|