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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 K080113
Device Name APEX DAL ELECTRONIC APEX LOCATOR
Applicant
Medicnrg , Ltd.
291 Hillside Ave.
Somerset,  MA  02726
Applicant Contact GEORGE J HATTUB
Correspondent
Medicnrg , Ltd.
291 Hillside Ave.
Somerset,  MA  02726
Correspondent Contact GEORGE J HATTUB
Classification Product Code
LQY  
Date Received01/16/2008
Decision Date 02/15/2008
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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