The following data is part of a premarket notification filed by Sheridan Catheter Corp. with the FDA for Bell/mckay Tracheal Tube.
| Device ID | K872616 |
| 510k Number | K872616 |
| Device Name: | BELL/MCKAY TRACHEAL TUBE |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | SHERIDAN CATHETER CORP. ROUTE 40 Argyle, NY 12809 |
| Contact | Steen, Phd |
| Correspondent | Steen, Phd SHERIDAN CATHETER CORP. ROUTE 40 Argyle, NY 12809 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-06 |
| Decision Date | 1987-08-10 |