K900478 is an FDA 510(k) clearance for the WOODLYN FULL APERTURE TRIAL LENS SET. This device is classified as a Set, Lens, Trial, Ophthalmic (Class I - General Controls, product code HPC).
Submitted by Woodlyn, Inc. (Arlington Heights, US). The FDA issued a Cleared decision on February 21, 1990, 20 days after receiving the submission on February 1, 1990.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1405.
| 510(k) Number | K900478 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 1990 |
| Decision Date | February 21, 1990 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HPC — Set, Lens, Trial, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1405 |