The following data is part of a premarket notification filed by Cc Wellness Llc with the FDA for Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant.
| Device ID | K200602 |
| 510k Number | K200602 |
| Device Name: | Premium Cooling Personal Lubricant, Premium Anal Cooling 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 | 2020-03-09 |
| Decision Date | 2020-06-03 |