Device Classification Name |
Condom
|
510(k) Number |
K895640 |
FOIA Releasable 510(k) |
K895640
|
Device Name |
MAGNUM PLUS LATEX CONDOM W/SPERMICIDAL LUBRICANT |
Applicant |
ARMKEL, LLC. |
HALF ACRE RD. |
P.O. BOX 1001 |
CRANBURY,
NJ
08512
|
|
Applicant Contact |
STEPHEN KOLAKOWSKY |
Correspondent |
ARMKEL, LLC. |
HALF ACRE RD. |
P.O. BOX 1001 |
CRANBURY,
NJ
08512
|
|
Correspondent Contact |
STEPHEN KOLAKOWSKY |
Regulation Number | 884.5300
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/19/1989 |
Decision Date | 01/23/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|