K930446 is an FDA 510(k) clearance for the MARCO TRIAL SETS. This device is classified as a Set, Lens, Trial, Ophthalmic (Class I - General Controls, product code HPC).
Submitted by Marco Ophthalmic, Inc. (Jacksonville, US). The FDA issued a Cleared decision on July 6, 1993, 161 days after receiving the submission on January 26, 1993.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1405.
| 510(k) Number | K930446 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 26, 1993 |
| Decision Date | July 06, 1993 |
| Days to Decision | 161 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HPC — Set, Lens, Trial, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1405 |