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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 K172270
Device Name gammaCore-2
Applicant
eletroCore, LLC
150 Allen Road, Suite 201
Basking Ridge,  NJ  07920
Applicant Contact Mike Romaniw
Correspondent
eletroCore, LLC
150 Allen Road, Suite 201
Basking Ridge,  NJ  07920
Correspondent Contact Mike Romaniw
Regulation Number882.5892
Classification Product Code
PKR  
Date Received07/28/2017
Decision Date 12/07/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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