Device Classification Name |
condom
|
510(k) Number |
K874236 |
Device Name |
APOLLO CONDOM |
Applicant |
APOLLO ENTERPRISE, LTD. CO. |
1395 N.W. 167 ST., STE. 103 |
MIAMI,
FL
33169
|
|
Applicant Contact |
HOWARD DOLLINGER,DDS |
Correspondent |
APOLLO ENTERPRISE, LTD. CO. |
1395 N.W. 167 ST., STE. 103 |
MIAMI,
FL
33169
|
|
Correspondent Contact |
HOWARD DOLLINGER,DDS |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 10/15/1987 |
Decision Date | 07/01/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|