K882762 is an FDA 510(k) clearance for the COLLAGEN SHIELD. This device is classified as a Collagen Corneal Shield (Class I - General Controls, product code MOE).
Submitted by Chiron Ophthalmics (Irvine, US). The FDA issued a Cleared decision on September 12, 1988, 68 days after receiving the submission on July 6, 1988.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4750.
| 510(k) Number | K882762 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 1988 |
| Decision Date | September 12, 1988 |
| Days to Decision | 68 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | MOE — Collagen Corneal Shield |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4750 |