K904961 is an FDA 510(k) clearance for the ARTIFICIAL SCLERAL SHELL. This device is classified as a Shell, Scleral (Class II - Special Controls, product code HQT).
Submitted by Midwest Eye Laboratories, Inc. (Minneapolis, US). The FDA issued a Cleared decision on August 30, 1991, 298 days after receiving the submission on November 5, 1990.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.3800.
| 510(k) Number | K904961 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 1990 |
| Decision Date | August 30, 1991 |
| Days to Decision | 298 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HQT — Shell, Scleral |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.3800 |