K812010 is an FDA 510(k) clearance for the KOI LACRIMAL INTUBATION SYSTEM. This device is classified as a Cannula, Ophthalmic (Class I - General Controls, product code HMX).
Submitted by Koi, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 28, 1981, 11 days after receiving the submission on July 17, 1981.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4350.
| 510(k) Number | K812010 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 17, 1981 |
| Decision Date | July 28, 1981 |
| Days to Decision | 11 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HMX — Cannula, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4350 |