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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name non-invasive vagus nerve stimulator - headache
510(k) Number K173442
Device Name gammaCore-S
Applicant
electroCore, LLC
150 Allen Road, Suite 201
basking ridge,  NJ  07920
Applicant Contact mike romaniw
Correspondent
electroCore, LLC
150 Allen Road, Suite 201
basking ridge,  NJ  07920
Correspondent Contact mike romaniw
Regulation Number882.5892
Classification Product Code
PKR  
Subsequent Product Code
QAK  
Date Received11/06/2017
Decision Date 01/23/2018
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
summary summary
Type Traditional
Clinical Trials NCT02686034
Reviewed by Third Party No
Combination Product No
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