The following data is part of a premarket notification filed by Bivona Medical Technologies with the FDA for Bivona Sleep Apnea Tube.
| Device ID | K915799 |
| 510k Number | K915799 |
| Device Name: | BIVONA SLEEP APNEA TUBE |
| Classification | Tube, Tracheal (w/wo Connector) |
| 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 | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-24 |
| Decision Date | 1992-02-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35021312010927 | K915799 | 000 |
| 35021312010910 | K915799 | 000 |
| 35021312010903 | K915799 | 000 |