OPHTHALMIC CAUTERY #6821-HOT-TEMP #'S
Device Facts
| Record ID | K833648 |
|---|---|
| Device Name | OPHTHALMIC CAUTERY #6821-HOT-TEMP #'S |
| Applicant | Edward Weck, Inc. |
| Product Code | HAM · General, Plastic Surgery |
| Decision Date | Nov 29, 1983 |
| 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.