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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Needle, Diagnostic Electromyograph
510(k) Number K161430
Device Name Myoject Luer Lock Needle Electrode
Applicant
Natus Manufacturing Limited
Ida Business Park
Gort,  IE
Applicant Contact Michael Galvin
Correspondent
Natus Manufacturing Limited
Ida Business Park
Gort,  IE
Correspondent Contact Michael Galvin
Regulation Number890.1385
Classification Product Code
IKT  
Date Received05/23/2016
Decision Date 03/02/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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