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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 K140094
Device Name SPRINGTMS TOTAL MIGRAINE SYSTEM
Applicant
ENEURA THERAPEUTICS, LLC
2690 PHEASANT ROAD
ORONO,  MN  55331
Applicant Contact LARRY GETLIN
Correspondent
ENEURA THERAPEUTICS, LLC
2690 PHEASANT ROAD
ORONO,  MN  55331
Correspondent Contact LARRY GETLIN
Regulation Number882.5808
Classification Product Code
OKP  
Date Received01/14/2014
Decision Date 05/21/2014
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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