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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handle, Instrument, Dental
510(k) Number K023367
Device Name DETECTAR, MODEL N123-MI
Applicant
Neks Technologies
103 Nolen Ln.
Chapel Hill,  NC  27516
Applicant Contact CHARLES H KYPER
Correspondent
Neks Technologies
103 Nolen Ln.
Chapel Hill,  NC  27516
Correspondent Contact CHARLES H KYPER
Regulation Number872.4565
Classification Product Code
EJB  
Subsequent Product Code
NBL  
Date Received10/08/2002
Decision Date 06/25/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
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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