LABELING CHANGES TO BIO-COR EXT COLLANGEN CORNEAL
Device Facts
| Record ID | K884364 |
|---|---|
| Device Name | LABELING CHANGES TO BIO-COR EXT COLLANGEN CORNEAL |
| Applicant | Bausch & Lomb Pharmaceutical, Inc. |
| Product Code | MOE · Ophthalmic |
| Decision Date | Nov 29, 1988 |
| 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.