MAGNA TEK ESU-400
Device Facts
| Record ID | K003471 |
|---|---|
| Device Name | MAGNA TEK ESU-400 |
| Applicant | Huttinger Medizintechnik GmbH & CO KG |
| Product Code | GEI · General, Plastic Surgery |
| Decision Date | Nov 20, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Attributes | 3rd-Party Reviewed |
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.
