The following data is part of a premarket notification filed by Bivona Medical Technologies with the FDA for Bivona Aire-cuf(r) Pediatric Tracheostomy Tube.
| Device ID | K914088 |
| 510k Number | K914088 |
| Device Name: | BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE |
| Classification | Tube Tracheostomy And Tube Cuff |
| 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 | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-11 |
| Decision Date | 1991-10-23 |