SPECTACLE FRAME
Device Facts
| Record ID | K944313 |
|---|---|
| Device Name | SPECTACLE FRAME |
| Applicant | Sun Hing Optical Manufactory , Ltd. |
| Product Code | HQZ · Ophthalmic |
| Decision Date | Mar 28, 1995 |
| 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.
