K913230 is an FDA 510(k) clearance for the UNIDIRECTIONAL OCCLUDER. This device is classified as a Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) (Class I - General Controls, product code HOY).
Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on October 2, 1991, 72 days after receiving the submission on July 22, 1991.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4750.
| 510(k) Number | K913230 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 22, 1991 |
| Decision Date | October 02, 1991 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HOY — Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4750 |