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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

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Device Classification Name non-invasive vagus nerve stimulator - headache
De Novo Number DEN150048
Device Name gammaCore Non-invasive Vagus Nerve Stimulator
electroCore, LLC
150 allen road, suite 201
basking ridge,  NJ  07920
Contact mike romaniw
Regulation Number882.5892
Classification Product Code
Date Received10/16/2015
Decision Date 04/14/2017
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct