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FDA 510(k) Application Details - K140094
Device Classification Name
More FDA Info for this Device
510(K) Number
K140094
Device Name
SPRINGTMS TOTAL MIGRAINE SYSTEM
Applicant
ENEURA THERAPEUTICS, LLC
2690 PHEASANT ROAD
ORONO, MN 55331 US
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Contact
LARRY GETLIN
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Regulation Number
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Classification Product Code
OKP
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Date Received
01/14/2014
Decision Date
05/21/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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