The following data is part of a premarket notification filed by Bioana Surgical Instruments, Inc. with the FDA for Aire-cuf Tracheostomy Tube.
| Device ID | K812163 |
| 510k Number | K812163 |
| Device Name: | AIRE-CUF TRACHEOSTOMY TUBE |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | BIOANA SURGICAL INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-29 |
| Decision Date | 1981-09-21 |