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510(k) K080824

BIO-CONSOLE 560 by Medtronic Perfusion Systems — Product Code DWA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 2008
Date Received
March 24, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, Pump Speed, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4380
Review Panel
CV
Submission Type

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