ENCORE ELECTROSURGICAL HANDCONTROL PENCIL (35001-001)
Device Facts
| Record ID | K970039 |
|---|---|
| Device Name | ENCORE ELECTROSURGICAL HANDCONTROL PENCIL (35001-001) |
| Applicant | Medtrex, Inc. |
| Product Code | GEI · General, Plastic Surgery |
| Decision Date | Feb 26, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.
