The following data is part of a premarket notification filed by J3 Bioscience, Inc. with the FDA for Vr101 Lubricating Intravaginal Ring.
| Device ID | K203377 |
| 510k Number | K203377 |
| Device Name: | VR101 Lubricating Intravaginal Ring |
| Classification | Lubricant, Personal |
| Applicant | J3 Bioscience, Inc. 825 North 300 West, Suite N231 Salt Lake City, UT 84103 |
| Contact | R. Tyler Mccabe |
| Correspondent | R. Tyler Mccabe J3 Bioscience, Inc. 825 North 300 West, Suite N231 Salt Lake City, UT 84103 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-17 |
| Decision Date | 2021-05-20 |