Device Classification Name |
Condom
|
510(k) Number |
K864570 |
Device Name |
PAMITEX,LONG LOVE,DESIRE,SKIN LESS,GINZA,LOVE TIME |
Applicant |
DONGKUK TECHCO RUBBER INDUSTRIES |
U.C. IMPORT & CO. |
P.O. BOX 6161 |
BEVERLY HILLS,
CA
90212
|
|
Applicant Contact |
NAAMI |
Correspondent |
DONGKUK TECHCO RUBBER INDUSTRIES |
U.C. IMPORT & CO. |
P.O. BOX 6161 |
BEVERLY HILLS,
CA
90212
|
|
Correspondent Contact |
NAAMI |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 11/20/1986 |
Decision Date | 12/30/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|