EN BLOC BIOPSY SYSTEM
Device Facts
| Record ID | K003190 |
|---|---|
| Device Name | EN BLOC BIOPSY SYSTEM |
| Applicant | Neothermia Corp. |
| Product Code | GEI · General, Plastic Surgery |
| Decision Date | Jun 11, 2001 |
| 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.
