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
Other 510(k) Applications for this Company
Contact LARRY GETLIN
Other 510(k) Applications for this Contact
Regulation Number

  More FDA Info for this Regulation Number
Classification Product Code OKP
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact