K902558 is an FDA 510(k) clearance for the COLLAGEN SHIELD FOR ACUTE CARE. This device is classified as a Collagen Corneal Shield (Class I — General Controls, product code MOE).
Submitted by Vitaphore Corp. (Menlo Park, US). The FDA issued a Cleared decision on August 17, 1990, 67 days after receiving the submission on June 11, 1990.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4750.
| 510(k) Number | K902558 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 11, 1990 |
| Decision Date | August 17, 1990 |
| Days to Decision | 67 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 |