K812097 is an FDA 510(k) clearance for the KOI LACREMAL HOOK & DILATOR. This device is classified as a Dilator, Lachrymal (Class I - General Controls, product code HNW).
Submitted by Koi, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 18, 1981, 25 days after receiving the submission on July 24, 1981.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4350.
| 510(k) Number | K812097 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 24, 1981 |
| Decision Date | August 18, 1981 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HNW — Dilator, Lachrymal |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4350 |