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FDA 510(k) Application Details - K100631
Device Classification Name
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
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510(K) Number
K100631
Device Name
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Applicant
MEDTRONIC INC.
7611 NORTHLAND DRIVE
MINNEAPOLIS, MN 55428 US
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SUE FIDLER
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Regulation Number
870.4360
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Classification Product Code
KFM
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Date Received
03/05/2010
Decision Date
06/22/2010
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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