Device Classification Name |
Condom
|
510(k) Number |
K120286 |
Device Name |
TROJAN HER PLEASURE (RIBBED) ECSTASY LATEX CONDOM WITH LUBRICANT |
Applicant |
CHURCH & DWIGHT CO., INC. |
469 NORTH HARRISON ST. |
PRINCETON,
NJ
08543 -5297
|
|
Applicant Contact |
JOSEPH CICCONE |
Correspondent |
CHURCH & DWIGHT CO., INC. |
469 NORTH HARRISON ST. |
PRINCETON,
NJ
08543 -5297
|
|
Correspondent Contact |
JOSEPH CICCONE |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 01/31/2012 |
Decision Date | 06/19/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|