The following data is part of a premarket notification filed by Cc Wellness Llc with the FDA for H2o Cooling Personal Lubricant, H2o Anal Cooling Personal Lubricant, #lubelife Sensations Cooling, #lubelife Sensations Pleasure Kit For Two, Jo 2 To Tango For Me, Jo 2 To Tango Couples Pleasure Kit.
| Device ID | K210986 |
| 510k Number | K210986 |
| Device Name: | H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, #LubeLife Sensations Cooling, #LubeLife Sensations Pleasure Kit For Two, JO 2 To Tango For Me, JO 2 To Tango Couples Pleasure Kit |
| 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 | 2021-04-01 |
| Decision Date | 2021-06-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10796494000172 | K210986 | 000 |
| 10796494000707 | K210986 | 000 |
| 10796494000745 | K210986 | 000 |
| 10796494000738 | K210986 | 000 |
| 10796494000691 | K210986 | 000 |
| 10796494001667 | K210986 | 000 |
| 10796494001414 | K210986 | 000 |
| 10796494001483 | K210986 | 000 |