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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache
510(k) Number K162797
Device Name SpringTMS
Applicant
eNeura Inc.
715 North Pastoria Avenue
Sunnyvale,  CA  94085
Applicant Contact Larry W. Getlin
Correspondent
Larry W. Geltin
715 North Pastoria Avenue
Sunnyvale,  CA  94085
Correspondent Contact Larry W. Getlin
Regulation Number882.5808
Classification Product Code
OKP  
Date Received10/04/2016
Decision Date 06/26/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT02357381
Reviewed by Third Party No
Combination Product No
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