The following data is part of a premarket notification filed by Cc Wellness Llc with the FDA for Agape Cooling Personal Lubricant.
| Device ID | K200894 |
| 510k Number | K200894 |
| Device Name: | Agape Cooling Personal Lubricant |
| Classification | Lubricant, Personal |
| 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 | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-03 |
| Decision Date | 2020-07-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10796494000974 | K200894 | 000 |
| 10796494001049 | K200894 | 000 |