Clearance Summary
MAGNA TEK ESU-400 received FDA 510(k) clearance under submission number K003471, sponsored by Huttinger Medizintechnik GmbH & CO KG. 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 2000-11-20.
- Submission: K003471
- Applicant / Sponsor: Huttinger Medizintechnik GmbH & CO KG
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2000-11-20
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.