Device Classification Name |
condom
|
510(k) Number |
K960552 |
Device Name |
KNIGHT LIGHT NONLUBRICATED CONDOM |
Applicant |
GLOBAL PROTECTION CORP. |
116 VILLAGE BLVD. |
SUITE 200 |
PRINCETON,
NJ
08540 -5799
|
|
Applicant Contact |
THOMAS BECZE |
Correspondent |
GLOBAL PROTECTION CORP. |
116 VILLAGE BLVD. |
SUITE 200 |
PRINCETON,
NJ
08540 -5799
|
|
Correspondent Contact |
THOMAS BECZE |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 02/08/1996 |
Decision Date | 11/20/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|