K931678 is an FDA 510(k) clearance for the ORTHOMET LHMC FEMORAL STEM. This device is classified as a Monitor, Eye Movement, Diagnostic (Class II - Special Controls, product code HMC).
Submitted by Orthomet, Inc. (Minneapolis, US). The FDA issued a Cleared decision on October 14, 1994, 556 days after receiving the submission on April 6, 1993.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1510.
| 510(k) Number | K931678 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 1993 |
| Decision Date | October 14, 1994 |
| Days to Decision | 556 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HMC — Monitor, Eye Movement, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1510 |