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FDA 510(k) Application Details - K051303
Device Classification Name
Control, Pump Speed, Cardiopulmonary Bypass
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510(K) Number
K051303
Device Name
Control, Pump Speed, Cardiopulmonary Bypass
Applicant
MEDTRONIC PERFUSION SYSTEMS
7611 NORTHLAND DR. N
MINNEAPOLIS, MN 55428 US
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Contact
DAWN M STENSTROM
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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
05/19/2005
Decision Date
06/10/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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