The following data is part of a premarket notification filed by United Consortium with the FDA for Jo Premium Personal Lubricant.
| Device ID | K132954 |
| 510k Number | K132954 |
| Device Name: | JO PREMIUM PERSONAL LUBRICANT |
| Classification | Lubricant, Personal |
| Applicant | UNITED CONSORTIUM 29000 HANCOCK PKWY Valencia, CA 91355 |
| Contact | Craig May |
| Correspondent | Craig May UNITED CONSORTIUM 29000 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 | 2013-09-20 |
| Decision Date | 2014-06-11 |
| Summary: | summary |