The following data is part of a premarket notification filed by United Consortium with the FDA for Bucked Stride Silicone Lubricant, #lubelife Thin Silicone Lubricant, Jo Xtra Silky Ultra-thin Silicone Personal Lubricant.
| Device ID | K190858 |
| 510k Number | K190858 |
| Device Name: | Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone 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 | 2019-04-02 |
| Decision Date | 2019-09-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10796494001896 | K190858 | 000 |
| 10796494005023 | K190858 | 000 |
| 10796494004507 | K190858 | 000 |
| 10796494001322 | K190858 | 000 |
| 10796494001339 | K190858 | 000 |
| 10796494003999 | K190858 | 000 |
| 10796494002206 | K190858 | 000 |
| 10796494002350 | K190858 | 000 |
| 10796494003609 | K190858 | 000 |
| 10796494003623 | K190858 | 000 |
| 10796494001872 | K190858 | 000 |
| 00796494001882 | K190858 | 000 |
| 10796494005252 | K190858 | 000 |