The following data is part of a premarket notification filed by Cc Wellness Llc with the FDA for Actively Trying Personal Lubricant Rose Scented.
| Device ID | K212885 |
| 510k Number | K212885 |
| Device Name: | Actively Trying Personal Lubricant Rose Scented |
| Classification | Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible |
| Applicant | CC Wellness LLC 29000 N. Hancock Pkwy. Valencia, CA 91355 |
| Contact | Marlent Perez |
| Correspondent | Marlent Perez CC Wellness LLC 29000 N. Hancock Pkwy. Valencia, CA 91355 |
| Product Code | PEB |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-10 |
| Decision Date | 2022-02-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10796494001803 | K212885 | 000 |