The following data is part of a premarket notification filed by Cc Wellness Llc with the FDA for Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-in-one Warming.
| Device ID | K200457 |
| 510k Number | K200457 |
| Device Name: | Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming |
| 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 | 2020-02-25 |
| Decision Date | 2020-05-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10796494000417 | K200457 | 000 |
| 10796494000400 | K200457 | 000 |
| 10796494000998 | K200457 | 000 |
| 10796494004859 | K200457 | 000 |