K926288 is an FDA 510(k) clearance for the SOM 6VI (SURGICAL OPERATING MICROSCOPE). This device is classified as a Microscope, Surgical, General & Plastic Surgery (Class I - General Controls, product code FSO).
Submitted by Jedmed Instrument Co. (St.Louis, US). The FDA issued a Cleared decision on October 12, 1993, 302 days after receiving the submission on December 14, 1992.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4700.
| 510(k) Number | K926288 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 14, 1992 |
| Decision Date | October 12, 1993 |
| Days to Decision | 302 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | FSO — Microscope, Surgical, General & Plastic Surgery |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4700 |