3MM DISPOSABLE SPECULA
Device Facts
| Record ID | K891589 |
|---|---|
| Device Name | 3MM DISPOSABLE SPECULA |
| Applicant | Semantodontics, Inc. |
| Product Code | FXG · General, Plastic Surgery |
| Decision Date | Apr 18, 1989 |
| 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.
