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FDA 510(k) Application Details - K070286
Device Classification Name
Control, Pump Speed, Cardiopulmonary Bypass
More FDA Info for this Device
510(K) Number
K070286
Device Name
Control, Pump Speed, Cardiopulmonary Bypass
Applicant
Medtronic
7611 NORTHLAND DRIVE
MINNEAPOLIS, MN 55428 US
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Contact
CHERYL NORTON
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Regulation Number
870.4380
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Classification Product Code
DWA
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More FDA Info for this Product Code
Date Received
01/29/2007
Decision Date
05/22/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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