SOFTSHIELD(TM) 12, 24, 72 COLLAGEN CORNEAL SHIELDS
Device Facts
| Record ID | K914529 |
|---|---|
| Device Name | SOFTSHIELD(TM) 12, 24, 72 COLLAGEN CORNEAL SHIELDS |
| Applicant | Oasis Medical, Inc. |
| Product Code | MOE · Ophthalmic |
| Decision Date | Nov 13, 1991 |
| 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.
