K830430 is an FDA 510(k) clearance for the EYELID SPECULUM. This device is classified as a Specula, Ophthalmic (Class I - General Controls, product code HNC).
Submitted by Douglas C. Mckee & Co. (Mchenry, US). The FDA issued a Cleared decision on June 10, 1983, 121 days after receiving the submission on February 9, 1983.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4350.
| 510(k) Number | K830430 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 09, 1983 |
| Decision Date | June 10, 1983 |
| Days to Decision | 121 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HNC — Specula, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4350 |