K844553 is an FDA 510(k) clearance for the MICRA DIAMOND KNIFE MICRA ADJUSTABLE KNIFE. This device is classified as a Knife, Ophthalmic (Class I - General Controls, product code HNN).
Submitted by Codman & Shurtleff, Inc. (Randolph, US). The FDA issued a Cleared decision on December 11, 1984, 20 days after receiving the submission on November 21, 1984.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4350.
| 510(k) Number | K844553 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 1984 |
| Decision Date | December 11, 1984 |
| Days to Decision | 20 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 |