Device Classification Name |
condom
|
510(k) Number |
K880919 |
Device Name |
(CHOICE) ALSO (KONDUM) |
Applicant |
SELECT SOURCES, INC. |
P.O. BOX 25B01 |
LOS ANGELES,
CA
90025
|
|
Applicant Contact |
ALLEN S FARSHI |
Correspondent |
SELECT SOURCES, INC. |
P.O. BOX 25B01 |
LOS ANGELES,
CA
90025
|
|
Correspondent Contact |
ALLEN S FARSHI |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 03/04/1988 |
Decision Date | 06/29/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|