The following data is part of a premarket notification filed by United Consortium with the FDA for Jo Agape Original Personal Lubricant, Muse Essence Water-based Lubricant, #lubelife Water-based Lubricant, #lubelife Water-based Anal Lubricant.
| Device ID | K183384 |
| 510k Number | K183384 |
| Device Name: | JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant |
| Classification | Lubricant, Personal |
| Applicant | United Consortium 29000 N. Hancock Pkwy. Valencia, CA 91355 |
| Contact | Stephanie Morris |
| Correspondent | Stephanie Morris United Consortium 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 | 2018-12-06 |
| Decision Date | 2019-03-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10796494001834 | K183384 | 000 |
| 10796494001230 | K183384 | 000 |
| 10796494001247 | K183384 | 000 |
| 10796494001438 | K183384 | 000 |
| 10796494001445 | K183384 | 000 |
| 10796494001452 | K183384 | 000 |
| 10796494001469 | K183384 | 000 |
| 10796494001308 | K183384 | 000 |
| 10796494001315 | K183384 | 000 |
| 10796494001698 | K183384 | 000 |
| 10796494001711 | K183384 | 000 |
| 10796494001223 | K183384 | 000 |