The following data is part of a premarket notification filed by Bioseal with the FDA for Fixation Device, Trach Tube.
| Device ID | K882694 |
| 510k Number | K882694 |
| Device Name: | FIXATION DEVICE, TRACH TUBE |
| Classification | Device, Fixation, Tracheal Tube |
| Applicant | BIOSEAL 350 NORTH PALM Brea, CA 92621 |
| Contact | William L Runion |
| Correspondent | William L Runion BIOSEAL 350 NORTH PALM Brea, CA 92621 |
| Product Code | CBH |
| CFR Regulation Number | 868.5770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-27 |
| Decision Date | 1988-08-15 |