ARCTIC PREMIER SERIES
Device Facts
| Record ID | K944700 |
|---|---|
| Device Name | ARCTIC PREMIER SERIES |
| Applicant | Sungold Eyewear, Inc. |
| Product Code | HOY · Ophthalmic |
| Decision Date | Dec 22, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.4750 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An ophthalmic eye shield is a device that consists of a plastic or aluminum eye covering intended to protect the eye or retain dressing materials in place.
