Device Classification Name |
condom
|
510(k) Number |
K872005 |
Device Name |
MAXIMUM, LATEX PROPHYLACTIC BRAND |
Applicant |
SAFE PRODUCT SUPPLIES |
6399 WILSHIRE BLVD.# 310 |
LOS ANGELES,
CA
90048
|
|
Applicant Contact |
KHALIL HAKIMIAN |
Correspondent |
SAFE PRODUCT SUPPLIES |
6399 WILSHIRE BLVD.# 310 |
LOS ANGELES,
CA
90048
|
|
Correspondent Contact |
KHALIL HAKIMIAN |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 05/26/1987 |
Decision Date | 11/02/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|