K770389 is an FDA 510(k) clearance for the LENS SET, MENTOR TRIAL. This device is classified as a Set, Lens, Trial, Ophthalmic (Class I - General Controls, product code HPC).
Submitted by Codman & Shurtleff, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 14, 1977, 14 days after receiving the submission on February 28, 1977.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1405.
| 510(k) Number | K770389 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 1977 |
| Decision Date | March 14, 1977 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | - |
| Product Code | HPC - Set, Lens, Trial, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1405 |