Device Classification Name |
condom
|
510(k) Number |
K897129 |
Device Name |
CONDOMS (MULTIPLE BRANDS) |
Applicant |
SAGAMI, INC. |
8725 WEST HIGGINS RD. |
SUITE 481 |
CHICAGO,
IL
60631
|
|
Applicant Contact |
TIM WEAVER |
Correspondent |
SAGAMI, INC. |
8725 WEST HIGGINS RD. |
SUITE 481 |
CHICAGO,
IL
60631
|
|
Correspondent Contact |
TIM WEAVER |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 12/26/1989 |
Decision Date | 05/16/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|