K855105 is an FDA 510(k) clearance for the SIMMONS SHELL. This device is classified as a Shell, Scleral (Class II - Special Controls, product code HQT).
Submitted by Mira, Inc. (Waltham, US). The FDA issued a Cleared decision on March 31, 1986, 98 days after receiving the submission on December 23, 1985.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.3800.
| 510(k) Number | K855105 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 1985 |
| Decision Date | March 31, 1986 |
| Days to Decision | 98 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 |