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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 K182369
Device Name gammaCore Sapphire
Applicant
Electrocore, Inc.
150 Allen Road, Suite 201
basking ridge,  NJ  07920
Applicant Contact mike romaniw
Correspondent
Electrocore, Inc.
150 Allen Road, Suite 201
basking ridge,  NJ  07920
Correspondent Contact mike romaniw
Regulation Number882.5892
Classification Product Code
PKR  
Date Received08/31/2018
Decision Date 11/27/2018
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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