The following data is part of a premarket notification filed by Cc Wellness Llc with the FDA for H2o Warming Personal Lubricant, H2o Anal Warming Personal Lubricant, Jo 2 To Tango For You, Jo 2 To Tango Couples Pleasure Kit, #lubelife Sensations Warming, #lubelife Sensations Pleasure Kit For Two.
| Device ID | K210972 |
| 510k Number | K210972 |
| Device Name: | H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango For You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming, #LubeLife Sensations Pleasure Kit For Two |
| Classification | Lubricant, Personal |
| Applicant | CC Wellness LLC 29000 N. Hancock Pkwy. Valencia, CA 91344 |
| Contact | Marlent Perez |
| Correspondent | Marlent Perez CC Wellness LLC 29000 N. Hancock Pkwy. Valencia, CA 91344 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-31 |
| Decision Date | 2021-06-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10796494000424 | K210972 | 000 |
| 10796494001407 | K210972 | 000 |
| 10796494001490 | K210972 | 000 |
| 10796494001674 | K210972 | 000 |
| 10796494000981 | K210972 | 000 |
| 10796494000523 | K210972 | 000 |
| 10796494000530 | K210972 | 000 |
| 10796494000431 | K210972 | 000 |
| 10796494000448 | K210972 | 000 |
| 10796494003715 | K210972 | 000 |