The following data is part of a premarket notification filed by Frederic J. Toye, M.d. with the FDA for Modified Pertrach Disp. Pediatric Percut. Tracheo..
| Device ID | K871199 |
| 510k Number | K871199 |
| Device Name: | MODIFIED PERTRACH DISP. PEDIATRIC PERCUT. TRACHEO. |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | FREDERIC J. TOYE, M.D. SUITE 105 DOCTORS OFFICE BLDG. #4 HOSPITAL PLAZA Clarksburg, WV 26301 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-25 |
| Decision Date | 1987-06-08 |