The following data is part of a premarket notification filed by Sheridan Catheter Corp. with the FDA for Laryngectomy Tube, Cuffed.
| Device ID | K860176 |
| 510k Number | K860176 |
| Device Name: | LARYNGECTOMY TUBE, CUFFED |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | SHERIDAN CATHETER CORP. ROUTE 40 Argyle, NY 12809 |
| Contact | Steen, Ph.d. |
| Correspondent | Steen, Ph.d. SHERIDAN CATHETER CORP. ROUTE 40 Argyle, NY 12809 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-17 |
| Decision Date | 1986-01-27 |