The following data is part of a premarket notification filed by Cc Wellness Llc with the FDA for Actively Trying Personal Lubricant Unfragrance.
Device ID | K212705 |
510k Number | K212705 |
Device Name: | Actively Trying Personal Lubricant Unfragrance |
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 | 2021-08-26 |
Decision Date | 2022-02-09 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10796494001797 | K212705 | 000 |
10796494001636 | K212705 | 000 |
10796494002923 | K212705 | 000 |
10796494002916 | K212705 | 000 |
00796494002773 | K212705 | 000 |
10796494002657 | K212705 | 000 |
00810028776166 | K212705 | 000 |