Device Classification Name |
condom
|
510(k) Number |
K024324 |
Device Name |
LATEX CONDOM AND LATEX CONDOM LUBRICATED WITH NONOXYNOL-9 |
Applicant |
GLOBAL PROTECTION CORP. |
12 CHANNEL ST. |
BOSTON,
MA
02210
|
|
Applicant Contact |
DAVIN T WEDEL |
Correspondent |
GLOBAL PROTECTION CORP. |
12 CHANNEL ST. |
BOSTON,
MA
02210
|
|
Correspondent Contact |
DAVIN T WEDEL |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 12/26/2002 |
Decision Date | 03/25/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|