The following data is part of a premarket notification filed by Church & Dwight Co., Inc. with the FDA for Trojan Jaguar Male Natural Rubber Latex Condom With Warming And Tingling Lubricant.
Device ID | K131887 |
510k Number | K131887 |
Device Name: | TROJAN JAGUAR MALE NATURAL RUBBER LATEX CONDOM WITH WARMING AND TINGLING LUBRICANT |
Classification | Condom |
Applicant | CHURCH & DWIGHT CO., INC. 500 CHARLES EWING BLVD Ewing, NJ 08628 |
Contact | Emily Perez |
Correspondent | Emily Perez CHURCH & DWIGHT CO., INC. 500 CHARLES EWING BLVD Ewing, NJ 08628 |
Product Code | HIS |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-06-25 |
Decision Date | 2013-10-24 |
Summary: | summary |