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 |