The following data is part of a premarket notification filed by Pertrach with the FDA for Modified Adult Cricothyroidotomy Kit.
| Device ID | K885139 |
| 510k Number | K885139 |
| Device Name: | MODIFIED ADULT CRICOTHYROIDOTOMY KIT |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | PERTRACH BOX 1158 109 KELLY DR. Bridgeport, WV 26330 |
| Contact | Toye, Md |
| Correspondent | Toye, Md PERTRACH BOX 1158 109 KELLY DR. Bridgeport, WV 26330 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-15 |
| Decision Date | 1989-05-25 |