Clearance Summary
DORNIER THERMAFOCUS 360 FIBER received FDA 510(k) clearance under submission number K950996, sponsored by Daimler-Benz Aerospace. 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 1995-10-03.
- Submission: K950996
- Applicant / Sponsor: Daimler-Benz Aerospace
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 1995-10-03
Classification & Regulation
This clearance is catalogued under FDA product code GEX and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.