K820254 is an FDA 510(k) clearance for the GOLD FOIL ERG ELECTRODES. This device is classified as a Electrode, Corneal (Class II - Special Controls, product code HLZ).
Submitted by Cadwell Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 9, 1982, 67 days after receiving the submission on February 1, 1982.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1220.
| 510(k) Number | K820254 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 1982 |
| Decision Date | April 09, 1982 |
| Days to Decision | 67 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HLZ — Electrode, Corneal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1220 |