K781411 is an FDA 510(k) clearance for the CORNEAL CUTTER AND ACCESSORIES. This device is classified as a Trephine, Manual, Ophthalmic (Class I - General Controls, product code HRH).
Submitted by Codman & Shurtleff, Inc. (Walker, US). The FDA issued a Cleared decision on September 20, 1978, 36 days after receiving the submission on August 15, 1978.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4350.
| 510(k) Number | K781411 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 15, 1978 |
| Decision Date | September 20, 1978 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | - |
| Product Code | HRH - Trephine, Manual, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4350 |