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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 K203546
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  
Subsequent Product Code
QAK  
Date Received12/04/2020
Decision Date 02/12/2021
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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