The following data is part of a premarket notification filed by Bivona Medical Technologies with the FDA for Burget Nasal Stent.
| Device ID | K942025 |
| 510k Number | K942025 |
| Device Name: | BURGET NASAL STENT |
| Classification | Dilator, Nasal |
| Applicant | BIVONA MEDICAL TECHNOLOGIES 5700 WEST 23RD AVE. Gary, IN 46406 |
| Contact | H. M Kaufman |
| Correspondent | H. M Kaufman BIVONA MEDICAL TECHNOLOGIES 5700 WEST 23RD AVE. Gary, IN 46406 |
| Product Code | LWF |
| CFR Regulation Number | 874.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-26 |
| Decision Date | 1995-10-27 |