FRAME, SPECTACLES
Device Facts
| Record ID | K945350 |
|---|---|
| Device Name | FRAME, SPECTACLES |
| Applicant | Taiwan Eva Industrial Co., Inc. |
| Product Code | HQZ · Ophthalmic |
| Decision Date | Dec 13, 1994 |
| 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.
