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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 K173815
Device Name Allergan Botox Needle Electrode
Applicant
Natus Manufacturing Limited
Ida Business Park
Gort,  IE h91 pd92
Applicant Contact Maria Connolly
Correspondent
Natus Manufacturing Limited
Ida Business Park
Gort,  IE h91 pd92
Correspondent Contact Martha Kennedy
Regulation Number890.1385
Classification Product Code
IKT  
Date Received12/15/2017
Decision Date 06/29/2018
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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