K813156 is an FDA 510(k) clearance for the ULTRA-WIDE SAFETY SPECTACLE FRAME. This device is classified as a Frame, Spectacle (Class I - General Controls, product code HQZ).
Submitted by Zee Medical Products Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on December 14, 1981, 38 days after receiving the submission on November 6, 1981.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5842.
| 510(k) Number | K813156 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 06, 1981 |
| Decision Date | December 14, 1981 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HQZ — Frame, Spectacle |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.5842 |