Device Classification Name |
condom
|
510(k) Number |
K872799 |
Device Name |
KIMONO (CONDOMS) |
Applicant |
MAYER LABORATORIES |
1611 TELEGRAPH AVENUE, SUITE |
830 |
OAKLAND,
CA
94612
|
|
Applicant Contact |
DAVID P MAYER |
Correspondent |
MAYER LABORATORIES |
1611 TELEGRAPH AVENUE, SUITE |
830 |
OAKLAND,
CA
94612
|
|
Correspondent Contact |
DAVID P MAYER |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 07/15/1987 |
Decision Date | 12/08/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|