The following data is part of a premarket notification filed by United Consortium with the FDA for Jo H2o Jelly Original Personal Lubricant.
| Device ID | K183584 |
| 510k Number | K183584 |
| Device Name: | JO H2O Jelly Original Personal 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 | 2018-12-21 |
| Decision Date | 2019-04-17 |