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510(k) K070286

BIO-CONSOLE, MODEL 560 by Medtronic — Product Code DWA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2007
Date Received
January 29, 2007
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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