Clearance Summary
SORING GMBH, ARCO 3000, ARCO 2000, ARCO 1000, MBC 601, MBC 600 received FDA 510(k) clearance under submission number K993265, sponsored by Soring GmbH Medizintechnik. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1999-10-22.
- Submission: K993265
- Applicant / Sponsor: Soring GmbH Medizintechnik
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 1999-10-22
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.