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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 K053235
Device Name NSK PRECISION APEX LOCATOR (PAL)
Applicant
Medicsense USA
291 Hillside Ave.
Somerset,  MA  02726
Applicant Contact George Hattub
Correspondent
Medicsense USA
291 Hillside Ave.
Somerset,  MA  02726
Correspondent Contact George Hattub
Classification Product Code
LQY  
Date Received11/18/2005
Decision Date 01/24/2006
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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