Clearance Summary
BERGEN MODEL 500 ELECTROSURGERY GENERATOR received FDA 510(k) clearance under submission number K972299, sponsored by Bergen Mfg.. 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 1997-08-27.
- Submission: K972299
- Applicant / Sponsor: Bergen Mfg.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 1997-08-27
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.