LABELING CHANGES TO FYODOROV COLLAGEN CORNEAL SHLD
Device Facts
| Record ID | K884362 |
|---|---|
| Device Name | LABELING CHANGES TO FYODOROV COLLAGEN CORNEAL SHLD |
| Applicant | Bausch & Lomb Pharmaceutical, Inc. |
| Product Code | HQJ · Ophthalmic |
| Decision Date | Nov 29, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.3300 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An absorbable implant (scleral buckling method) is a device intended to be implanted on the sclera to aid retinal reattachment.