The following data is part of a premarket notification filed by Denver Splint Co. with the FDA for The Denver Cautery.
| Device ID | K922062 |
| 510k Number | K922062 |
| Device Name: | THE DENVER CAUTERY |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | DENVER SPLINT CO. 6099 S. QUEBEC ST. SUITE 200 Englewood, CO 80111 |
| Contact | Ron Shippert |
| Correspondent | Ron Shippert DENVER SPLINT CO. 6099 S. QUEBEC ST. SUITE 200 Englewood, CO 80111 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-04 |
| Decision Date | 1993-01-12 |