The following data is part of a premarket notification filed by Sheridan Catheter Corp. with the FDA for Laser Resistant Tracheal Tube.
| Device ID | K897046 |
| 510k Number | K897046 |
| Device Name: | LASER RESISTANT TRACHEAL TUBE |
| Classification | Tube, Tracheal/bronchial, Differential Ventilation (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 | CBI |
| CFR Regulation Number | 868.5740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-18 |
| Decision Date | 1990-03-23 |