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LMT NOMAG IC 3.0

K062052 Class II Traditional
Decision Date
2006-07-31
Sponsor / Applicant
Lmt Lammers Medical Technology GmbH

Technical Specification

510(k) Submission ID K062052
Product Code FPL
Medical Specialty / Panel General Hospital
Regulation Citation 21 CFR 880.5410
Decision Date 2006-07-31
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

LMT NOMAG IC 3.0 received FDA 510(k) clearance under submission number K062052, sponsored by Lmt Lammers Medical Technology GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2006-07-31.

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.