K833669 is an FDA 510(k) clearance for the IMAGE DEFLECTOR. This device is classified as a Frame, Trial, Ophthalmic (Class I — General Controls, product code HPA).
Submitted by Michael Onufryk (Mchenry, US). The FDA issued a Cleared decision on March 27, 1984, 161 days after receiving the submission on October 18, 1983.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1415.
| 510(k) Number | K833669 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 18, 1983 |
| Decision Date | March 27, 1984 |
| Days to Decision | 161 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HPA — Frame, Trial, Ophthalmic |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 886.1415 |