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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Locator, Root Apex
510(k) Number K022020
Device Name JUSTWO MODEL TME-601 ROOT APEX LOCATOR
Applicant
Toei Electric Co., Ltd.
P.O. Box 7007
Deer Field,  IL  60015
Applicant Contact DANIEL KAMM
Correspondent
Toei Electric Co., Ltd.
P.O. Box 7007
Deer Field,  IL  60015
Correspondent Contact DANIEL KAMM
Classification Product Code
LQY  
Date Received06/20/2002
Decision Date 07/02/2002
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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