The following data is part of a premarket notification filed by Church & Dwight Virginia Co., Inc. with the FDA for Trojan Magnum Condom With Warming Lubricant.
Device ID | K120249 |
510k Number | K120249 |
Device Name: | TROJAN MAGNUM CONDOM WITH WARMING LUBRICANT |
Classification | Condom |
Applicant | CHURCH & DWIGHT VIRGINIA CO., INC. 469 NORTH HARRISON STREET Princeton, NJ 08543 |
Contact | Joseph Ciccone |
Correspondent | Joseph Ciccone CHURCH & DWIGHT VIRGINIA CO., INC. 469 NORTH HARRISON STREET Princeton, NJ 08543 |
Product Code | HIS |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-01-27 |
Decision Date | 2012-05-11 |
Summary: | summary |