Clearance Summary
MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC) received FDA 510(k) clearance under submission number K081698, sponsored by Image Stream Medical, Inc.. 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 2008-07-30.
- Submission: K081698
- Applicant / Sponsor: Image Stream Medical, Inc.
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4580
- Decision date: 2008-07-30
Classification & Regulation
This clearance is catalogued under FDA product code FTA and 21 CFR 878.4580, within the General, Plastic Surgery review panel as a Class II device.