K931284 is an FDA 510(k) clearance for the MICRODYNE OFFICE SURGICAL MICROSCOPE. This device is classified as a Microscope, Surgical (Class I - General Controls, product code EPT).
Submitted by Microdyne, Inc. (Valley Center, US). The FDA issued a Cleared decision on November 18, 1993, 280 days after receiving the submission on February 11, 1993.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4700.
| 510(k) Number | K931284 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 1993 |
| Decision Date | November 18, 1993 |
| Days to Decision | 280 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | EPT — Microscope, Surgical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4700 |