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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 K032743
Device Name APEX NRG
Applicant
Medicnrg , Ltd.
Pob 367
Ramat Hasharon,,  IL 47103
Applicant Contact ADI ICKOWICZ
Correspondent
Medicnrg , Ltd.
Pob 367
Ramat Hasharon,,  IL 47103
Correspondent Contact ADI ICKOWICZ
Classification Product Code
LQY  
Date Received09/04/2003
Decision Date 03/15/2004
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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