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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 K161663
Device Name sTMS mini
Applicant
ENEURA INC
715 NORTH PASTORIA AVENUE
SUNNYVALE,  CA  94085
Applicant Contact CYNTHIA MERRELL
Correspondent
LARRY W. GETLIN
2690 PHEASANT ROAD
ORONO,  MN  55331
Correspondent Contact LARRY W. GETLIN
Regulation Number882.5808
Classification Product Code
OKP  
Date Received06/16/2016
Decision Date 08/23/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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