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JUSTWO MODEL TME-601 ROOT APEX LOCATOR

K022020 Special
Decision Date
2002-07-02
Sponsor / Applicant
Toei Electric Co., Ltd.

Technical Specification

510(k) Submission ID K022020
Product Code LQY
Medical Specialty / Panel Unknown
Decision Date 2002-07-02
Clearance Pathway Special

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

JUSTWO MODEL TME-601 ROOT APEX LOCATOR received FDA 510(k) clearance under submission number K022020, sponsored by Toei Electric Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 2002-07-02.

Classification & Regulation

This clearance is catalogued under FDA product code LQY , within the Unknown review panel as a device.