The following data is part of a premarket notification filed by Sheridan Catheter Corp. with the FDA for Tracheal Tube, Reinforced, Cuffed.
| Device ID | K844296 |
| 510k Number | K844296 |
| Device Name: | TRACHEAL TUBE, REINFORCED, CUFFED |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | SHERIDAN CATHETER CORP. ROUTE 40 Argyle, NY 12809 |
| Contact | John A Steen |
| Correspondent | John A Steen 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 | 1984-11-06 |
| Decision Date | 1984-12-04 |