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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
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