The following data is part of a premarket notification filed by Bivona Medical Technologies with the FDA for Bivona Nasal Turbinate Stent.
| Device ID | K935053 |
| 510k Number | K935053 |
| Device Name: | BIVONA NASAL TURBINATE STENT |
| Classification | Splint, Intranasal Septal |
| Applicant | BIVONA MEDICAL TECHNOLOGIES 5700 WEST 23RD AVE. Gary, IN 46406 |
| Contact | Harry M Kaufman |
| Correspondent | Harry M Kaufman BIVONA MEDICAL TECHNOLOGIES 5700 WEST 23RD AVE. Gary, IN 46406 |
| Product Code | LYA |
| CFR Regulation Number | 874.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-21 |
| Decision Date | 1994-07-01 |