The following data is part of a premarket notification filed by Church & Dwight Co., Inc. with the FDA for Pre-seed™ Fertility Lubricant.
Device ID | K193450 |
510k Number | K193450 |
Device Name: | Pre-Seed™ Fertility Lubricant |
Classification | Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible |
Applicant | Church & Dwight Co., Inc. 500 Charles Ewing Blvd. Ewing, NJ 08628 |
Contact | Joelle Reinson |
Correspondent | Joelle Reinson Church & Dwight Co., Inc. 500 Charles Ewing Blvd. Ewing, NJ 08628 |
Product Code | PEB |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-12-13 |
Decision Date | 2020-07-23 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PRE-SEED 78151552 2972756 Live/Registered |
CHURCH & DWIGHT CO., INC. 2002-08-06 |
PRE-SEED 78067561 2820397 Live/Registered |
CEDAR CONSULTANTS III LIMITED 2001-06-06 |