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FDA 510(k) Application Details - K041244
Device Classification Name
Device, Biofeedback
More FDA Info for this Device
510(K) Number
K041244
Device Name
Device, Biofeedback
Applicant
MEDTRONIC VASCULAR
4000 LEXINGTON AVE., NORTH
SHOREVIEW, MN 55126-2893 US
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Contact
JULIE GOODE
Other 510(k) Applications for this Contact
Regulation Number
882.5050
More FDA Info for this Regulation Number
Classification Product Code
HCC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/11/2004
Decision Date
08/12/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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