K863665 is an FDA 510(k) clearance for the THE ULTIMATE. This device is classified as a Knife, Ophthalmic (Class I - General Controls, product code HNN).
Submitted by Myocure, Inc. (Glendale, US). The FDA issued a Cleared decision on September 25, 1986, 7 days after receiving the submission on September 18, 1986.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4350.
| 510(k) Number | K863665 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 18, 1986 |
| Decision Date | September 25, 1986 |
| Days to Decision | 7 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HNN — Knife, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4350 |