K970327 is an FDA 510(k) clearance for the SCLERAL SHELL. This device is classified as a Shell, Scleral (Class II - Special Controls, product code HQT).
Submitted by Southwest Artificial Eyes, Inc. (San Antonio, US). The FDA issued a Cleared decision on July 7, 1997, 160 days after receiving the submission on January 28, 1997.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.3800.
| 510(k) Number | K970327 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 28, 1997 |
| Decision Date | July 07, 1997 |
| Days to Decision | 160 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HQT — Shell, Scleral |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.3800 |