K900091 is an FDA 510(k) clearance for the MODIFIED OPHTHALMIC OPIR ONUFRYK IMAGE DEFLECTOR. This device is classified as a Lens, Spectacle, Non-custom (prescription) (Class I - General Controls, product code HQG).
Submitted by Onufryk Low Vision Ent. (Fairport, US). The FDA issued a Cleared decision on April 4, 1990, 89 days after receiving the submission on January 5, 1990.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5844.
| 510(k) Number | K900091 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 05, 1990 |
| Decision Date | April 04, 1990 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HQG — Lens, Spectacle, Non-custom (prescription) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.5844 |