Device Classification Name |
condom
|
510(k) Number |
K901696 |
Device Name |
LATEX CONDOMS - CODE NO. 403, 406, 421 & 1033 |
Applicant |
ALLERCARE/NSL, INC. |
7150 N. RIDGEWAY |
LINCOLNWOOD,
IL
60645
|
|
Applicant Contact |
FRANK J GOLDBERG |
Correspondent |
ALLERCARE/NSL, INC. |
7150 N. RIDGEWAY |
LINCOLNWOOD,
IL
60645
|
|
Correspondent Contact |
FRANK J GOLDBERG |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 04/12/1990 |
Decision Date | 05/16/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|