The following data is part of a premarket notification filed by Rinovum Subsidiary 2, Llc with the FDA for Revive Reusable Bladder Support.
| Device ID | K183468 |
| 510k Number | K183468 |
| Device Name: | Revive Reusable Bladder Support |
| Classification | Pessary, Vaginal |
| Applicant | Rinovum Subsidiary 2, LLC 300 Oxford Drive, Suite 330 Monroeville, PA 15146 |
| Contact | Shaylee Masilunas |
| Correspondent | Shaylee Masilunas Rinovum Subsidiary 2, LLC 300 Oxford Drive, Suite 330 Monroeville, PA 15146 |
| Product Code | HHW |
| CFR Regulation Number | 884.3575 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-14 |
| Decision Date | 2019-01-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20854389008027 | K183468 | 000 |