EAR SURGERY SPECULUM
Device Facts
| Record ID | K822373 |
|---|---|
| Device Name | EAR SURGERY SPECULUM |
| Applicant | Treace Medical, Inc. |
| Product Code | EPY · General, Plastic Surgery |
| Decision Date | Sep 9, 1982 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.1800 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A speculum is a device intended to be inserted into a body cavity to aid observation. It is either nonilluminated or illuminated and may have various accessories.
