K890992 is an FDA 510(k) clearance for the WOODLYN OPHTHALMIC PROJECTOR. This device is classified as a Projector, Ophthalmic (Class I - General Controls, product code HOS).
Submitted by Woodlyn, Inc. (Arlington Heights, US). The FDA issued a Cleared decision on May 17, 1989, 79 days after receiving the submission on February 27, 1989.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1680.
| 510(k) Number | K890992 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 27, 1989 |
| Decision Date | May 17, 1989 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HOS — Projector, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1680 |