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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 K101177
Device Name APEXNRG RIDER
Applicant
Medicnrg , Ltd.
291 Hillside Ave.
Somerset,  MA  02726
Applicant Contact George Hattub
Correspondent
Medicnrg , Ltd.
291 Hillside Ave.
Somerset,  MA  02726
Correspondent Contact George Hattub
Classification Product Code
LQY  
Date Received04/27/2010
Decision Date 10/08/2010
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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