SPECTACLE FRAME, OP-TITE
Device Facts
| Record ID | K772368 |
|---|---|
| Device Name | SPECTACLE FRAME, OP-TITE |
| Applicant | Dentsply Intl. |
| Product Code | HQZ · Ophthalmic |
| Decision Date | Jan 30, 1978 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.5842 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A spectacle frame is a device made of metal or plastic intended to hold prescription spectacle lenses worn by a patient to correct refractive errors.
