Clearance Summary
SOM 6VI (SURGICAL OPERATING MICROSCOPE) received FDA 510(k) clearance under submission number K926288, sponsored by Jedmed Instrument Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1993-10-12.
- Submission: K926288
- Applicant / Sponsor: Jedmed Instrument Co.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4700
- Decision date: 1993-10-12
Classification & Regulation
This clearance is catalogued under FDA product code FSO and 21 CFR 878.4700, within the General, Plastic Surgery review panel as a Class I device.