The following data is part of a premarket notification filed by United Consortium with the FDA for Jo For Him H2o Gel Original Personal Lubricant.
| Device ID | K192203 |
| 510k Number | K192203 |
| Device Name: | JO For Him H2O Gel Original Personal Lubricant |
| Classification | Lubricant, Personal |
| Applicant | United Consortium 29000 N. Hancock Pkwy. Valencia, CA 91355 |
| Contact | Stephanie Morris |
| Correspondent | Marlent Perez 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 | 2019-08-14 |
| Decision Date | 2020-02-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10796494000868 | K192203 | 000 |
| 10796494000851 | K192203 | 000 |
| 10796494003548 | K192203 | 000 |
| 10796494003531 | K192203 | 000 |
| 10796494001902 | K192203 | 000 |