Device Classification Name |
Condom
|
510(k) Number |
K860680 |
Device Name |
PROTEX, TAHITI CONDOM |
Applicant |
U. C. IMPORT & CO. |
P.O. BOX 6161 |
BEVERLY HILLS,
PA
90212
|
|
Applicant Contact |
MAX NAAMI |
Correspondent |
U. C. IMPORT & CO. |
P.O. BOX 6161 |
BEVERLY HILLS,
PA
90212
|
|
Correspondent Contact |
MAX NAAMI |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 02/25/1986 |
Decision Date | 09/26/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|