The following data is part of a premarket notification filed by Frederic J. Toye, M.d. with the FDA for Cuffed Trachea Tube For Use W/pertrach.
| Device ID | K801379 |
| 510k Number | K801379 |
| Device Name: | CUFFED TRACHEA TUBE FOR USE W/PERTRACH |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | FREDERIC J. TOYE, M.D. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-06-11 |
| Decision Date | 1980-09-09 |