K801466 is an FDA 510(k) clearance for the LEIGH MEASURING SCALE #7725. This device is classified as a Gauge, Lens, Ophthalmic (Class I - General Controls, product code HLN).
Submitted by Edward Weck, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 28, 1980, 34 days after receiving the submission on June 24, 1980.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1420.
| 510(k) Number | K801466 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 1980 |
| Decision Date | July 28, 1980 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HLN — Gauge, Lens, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1420 |