K914529 is an FDA 510(k) clearance for the SOFTSHIELD(TM) 12, 24, 72 COLLAGEN CORNEAL SHIELDS. This device is classified as a Collagen Corneal Shield (Class I - General Controls, product code MOE).
Submitted by Oasis Medical, Inc. (Glendora, US). The FDA issued a Cleared decision on November 13, 1991, 33 days after receiving the submission on October 11, 1991.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4750.
| 510(k) Number | K914529 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 11, 1991 |
| Decision Date | November 13, 1991 |
| Days to Decision | 33 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | MOE - Collagen Corneal Shield |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4750 |