Clearance Summary
MODEL 80-1765 ELECTROSURGICAL UNIT received FDA 510(k) clearance under submission number K791415, sponsored by Cameron-Miller, Inc.. 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 1979-10-11.
- Submission: K791415
- Applicant / Sponsor: Cameron-Miller, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 1979-10-11
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.