Device Classification Name |
Condom
|
510(k) Number |
K001212 |
Device Name |
TROJAN EXTRA LARGE LATEX CONDOM |
Applicant |
ARMKEL, LLC. |
HALF ACRE RD. |
P.O. BOX 1001 |
CRANBURY,
NJ
08512
|
|
Applicant Contact |
STEPHEN C KOLAKOWSKY |
Correspondent |
ARMKEL, LLC. |
HALF ACRE RD. |
P.O. BOX 1001 |
CRANBURY,
NJ
08512
|
|
Correspondent Contact |
STEPHEN C KOLAKOWSKY |
Regulation Number | 884.5300
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/14/2000 |
Decision Date | 05/09/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|