K781465 is an FDA 510(k) clearance for the MICROSURGICAL KNIVES, 20, 30, 45. This device is classified as a Knife, Ophthalmic (Class I - General Controls, product code HNN).
Submitted by Codman & Shurtleff, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 20, 1978, 26 days after receiving the submission on August 25, 1978.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4350.
| 510(k) Number | K781465 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 1978 |
| Decision Date | September 20, 1978 |
| Days to Decision | 26 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 |