K873385 is an FDA 510(k) clearance for the OPHTHALMIC PHACO-BLADE. 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 21, 1987, 28 days after receiving the submission on August 24, 1987.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4350.
| 510(k) Number | K873385 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 24, 1987 |
| Decision Date | September 21, 1987 |
| Days to Decision | 28 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 |