The following data is part of a premarket notification filed by Davol, Inc. with the FDA for Single Use Monopolar Hand Control Pencil.
| Device ID | K791137 |
| 510k Number | K791137 |
| Device Name: | SINGLE USE MONOPOLAR HAND CONTROL PENCIL |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | DAVOL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-06-18 |
| Decision Date | 1979-07-24 |