K945392 is an FDA 510(k) clearance for the SPECTACLE FRAME. This device is classified as a Frame, Spectacle (Class I - General Controls, product code HQZ).
Submitted by Seo Han Corp., Ltd. (Daegu, KR). The FDA issued a Cleared decision on December 15, 1994, 42 days after receiving the submission on November 3, 1994.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5842.
| 510(k) Number | K945392 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 03, 1994 |
| Decision Date | December 15, 1994 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HQZ — Frame, Spectacle |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.5842 |