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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 K063843
Device Name APEXNRG XFR
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 Received12/26/2006
Decision Date 01/03/2007
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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