Clearance Summary
LMT NOMAG IC 1,5 received FDA 510(k) clearance under submission number K033565, sponsored by Lmt Lammers Medical Technology GmbH. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2003-11-21.
- Submission: K033565
- Applicant / Sponsor: Lmt Lammers Medical Technology GmbH
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5410
- Decision date: 2003-11-21
Classification & Regulation
This clearance is catalogued under FDA product code FPL and 21 CFR 880.5410, within the General Hospital review panel as a Class II device.