Device Classification Name |
condom
|
510(k) Number |
K993395 |
Device Name |
REMED MALE LATEX CONDOM (DOUBLE WHOOPER) PREVENTOR, LUCKY BOY AND SUMMIT |
Applicant |
REMED PHARMA |
PO BOX 4341 |
crofton,
MD
21114
|
|
Applicant Contact |
e.j. smith |
Correspondent |
REMED PHARMA |
PO BOX 4341 |
crofton,
MD
21114
|
|
Correspondent Contact |
e.j. smith |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 10/08/1999 |
Decision Date | 02/15/2000 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
statement |
statement
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|