Device Classification Name |
condom
|
510(k) Number |
K131887 |
Device Name |
TROJAN JAGUAR MALE NATURAL RUBBER LATEX CONDOM WITH WARMING AND TINGLING LUBRICANT |
Applicant |
CHURCH & DWIGHT CO., INC. |
500 CHARLES EWING BLVD |
EWING,
NJ
08628
|
|
Applicant Contact |
EMILY PEREZ |
Correspondent |
CHURCH & DWIGHT CO., INC. |
500 CHARLES EWING BLVD |
EWING,
NJ
08628
|
|
Correspondent Contact |
EMILY PEREZ |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 06/25/2013 |
Decision Date | 10/24/2013 |
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
|
|
|