ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999
Device Facts
| Record ID | K003403 |
|---|---|
| Device Name | ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999 |
| Applicant | Highland / Marietta, Inc. |
| Product Code | JOS · General, Plastic Surgery |
| Decision Date | May 7, 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.
