Clearance Summary
CONMED BEAMER SYSTEM C600 received FDA 510(k) clearance under submission number K081678, sponsored by Kls Martin GmbH + Co. KG. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2008-07-29.
- Submission: K081678
- Applicant / Sponsor: Kls Martin GmbH + Co. KG
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2008-07-29
Classification & Regulation
This clearance is catalogued under FDA product code GEI and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.