The following data is part of a premarket notification filed by Good Clean Love, Inc. with the FDA for Biogenesis Fertility Lubricant.
| Device ID | K190872 |
| 510k Number | K190872 |
| Device Name: | BioGenesis Fertility Lubricant |
| Classification | Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible |
| Applicant | Good Clean Love, Inc. 207 W. 5th Avenue Eugene, OR 97401 |
| Contact | Wendy Strgar |
| Correspondent | Abhishek Gurnani Amin Talati Upadhye, LLP 100 South Wacker Drive, Suite 2000 Chicago, IL 60606 |
| Product Code | PEB |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-03 |
| Decision Date | 2019-11-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00893268000802 | K190872 | 000 |