The following data is part of a premarket notification filed by Church & Dwight Co., Inc. with the FDA for Trojan Riviera Personal Lubricant.
Device ID | K150886 |
510k Number | K150886 |
Device Name: | Trojan Riviera Personal Lubricant |
Classification | Lubricant, Personal |
Applicant | CHURCH & DWIGHT CO., INC. 500 CHARLES EWING BLVD. Ewing, NJ 08628 |
Contact | Lisa Burns |
Correspondent | Lisa Burns CHURCH & DWIGHT CO., INC. 500 CHARLES EWING BLVD. Ewing, NJ 08628 |
Product Code | NUC |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-04-02 |
Decision Date | 2015-07-20 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00022600000303 | K150886 | 000 |