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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
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