Device Classification Name |
condom
|
510(k) Number |
K910470 |
Device Name |
CONDOMS, MOODS/SHARE & RAKSHAK |
Applicant |
HINDUSTAN LATEX LTD. |
3030 ANTLER DR. |
DOYLESTOWN,
PA
18901
|
|
Applicant Contact |
JAMES R COLLIE |
Correspondent |
HINDUSTAN LATEX LTD. |
3030 ANTLER DR. |
DOYLESTOWN,
PA
18901
|
|
Correspondent Contact |
JAMES R COLLIE |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 02/04/1991 |
Decision Date | 12/18/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|