The following data is part of a premarket notification filed by Frederic J. Toye, M.d. with the FDA for Emergency Tracheostomy & Cricothyroido-.
| Device ID | K830509 |
| 510k Number | K830509 |
| Device Name: | EMERGENCY TRACHEOSTOMY & CRICOTHYROIDO- |
| 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 | 1983-02-17 |
| Decision Date | 1983-03-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841470109063 | K830509 | 000 |