The following data is part of a premarket notification filed by United Consortium with the FDA for Jo Agapé Personal Lubricant.
| Device ID | K171021 |
| 510k Number | K171021 |
| Device Name: | JO Agapé 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 | 2017-04-05 |
| Decision Date | 2017-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B362440491 | K171021 | 000 |
| 10796494002008 | K171021 | 000 |
| 10796494001957 | K171021 | 000 |
| 10796494001940 | K171021 | 000 |
| 10796494001728 | K171021 | 000 |
| 10796494001681 | K171021 | 000 |
| 10796494001162 | K171021 | 000 |
| 10796494001155 | K171021 | 000 |
| 10796494001025 | K171021 | 000 |
| 10796494000967 | K171021 | 000 |
| 70796494004141 | K171021 | 000 |
| 10796494002336 | K171021 | 000 |
| 10796494002343 | K171021 | 000 |
| B362420080 | K171021 | 000 |
| B362410411 | K171021 | 000 |
| 10796494003487 | K171021 | 000 |
| 10796494003470 | K171021 | 000 |
| 10796494003029 | K171021 | 000 |
| 10796494003012 | K171021 | 000 |
| 10796494003005 | K171021 | 000 |
| 10796494002756 | K171021 | 000 |
| 10796494002404 | K171021 | 000 |
| 10796494002367 | K171021 | 000 |
| 10796494004279 | K171021 | 000 |