The following data is part of a premarket notification filed by Consolidated Medical Equipment, Inc. with the FDA for Hand Controlled Electrosurgical Pencil-reuseable.
| Device ID | K844371 |
| 510k Number | K844371 |
| Device Name: | HAND CONTROLLED ELECTROSURGICAL PENCIL-REUSEABLE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | CONSOLIDATED MEDICAL EQUIPMENT, INC. 310 BROAD ST. Utica, NY 13501 |
| Contact | William W Abraham |
| Correspondent | William W Abraham CONSOLIDATED MEDICAL EQUIPMENT, INC. 310 BROAD ST. Utica, NY 13501 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-13 |
| Decision Date | 1985-02-20 |