SHEA'S EAR SPECULUM HOLDER PORT MANNS
Device Facts
| Record ID | K822011 |
|---|---|
| Device Name | SHEA'S EAR SPECULUM HOLDER PORT MANNS |
| Applicant | Kelleher Corp. |
| Product Code | JYK · General, Plastic Surgery |
| Decision Date | Aug 12, 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.