K874225 is an FDA 510(k) clearance for the BIO-COR EXT COLLAGEN CORNEAL SHIELD. This device is classified as a Collagen Corneal Shield (Class I - General Controls, product code MOE).
Submitted by Bausch & Lomb, Inc. (Clearwater, US). The FDA issued a Cleared decision on January 22, 1988, 98 days after receiving the submission on October 16, 1987.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4750.
| 510(k) Number | K874225 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 16, 1987 |
| Decision Date | January 22, 1988 |
| Days to Decision | 98 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 |