K844409 is an FDA 510(k) clearance for the DTL ELECTRODE. This device is classified as a Electrode, Corneal (Class II - Special Controls, product code HLZ).
Submitted by Sauquoit Industries, Inc. (Scranton, US). The FDA issued a Cleared decision on February 14, 1985, 92 days after receiving the submission on November 14, 1984.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1220.
| 510(k) Number | K844409 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 1984 |
| Decision Date | February 14, 1985 |
| Days to Decision | 92 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 |