The following data is part of a premarket notification filed by Bivona Medical Technologies with the FDA for Bivona Endotracheal Tube Stylet.
| Device ID | K905052 |
| 510k Number | K905052 |
| Device Name: | BIVONA ENDOTRACHEAL TUBE STYLET |
| Classification | Stylet, Tracheal Tube |
| Applicant | BIVONA MEDICAL TECHNOLOGIES 5700 WEST 23RD AVE. Gary, IN 46406 |
| Contact | Harry M Kaufmann |
| Correspondent | Harry M Kaufmann BIVONA MEDICAL TECHNOLOGIES 5700 WEST 23RD AVE. Gary, IN 46406 |
| Product Code | BSR |
| CFR Regulation Number | 868.5790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-08 |
| Decision Date | 1991-04-02 |