Device Classification Name |
condom
|
510(k) Number |
K854622 |
Device Name |
PROPHYLACTIC (CONDOM) |
Applicant |
MEDELEC INTL. CORP. |
ONE LINCOLN ROAD, SUITE 304 |
MIAMI BEACH,
FL
33139
|
|
Applicant Contact |
OSCAR D DOCAL |
Correspondent |
MEDELEC INTL. CORP. |
ONE LINCOLN ROAD, SUITE 304 |
MIAMI BEACH,
FL
33139
|
|
Correspondent Contact |
OSCAR D DOCAL |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 11/18/1985 |
Decision Date | 04/11/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|