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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Control, Pump Speed, Cardiopulmonary Bypass
510(k) Number K070286
Device Name BIO-CONSOLE, MODEL 560
Applicant
Medtronic
7611 Northland Dr.
Minneapolis,  MN  55428
Applicant Contact CHERYL NORTON
Correspondent
Medtronic
7611 Northland Dr.
Minneapolis,  MN  55428
Correspondent Contact CHERYL NORTON
Regulation Number870.4380
Classification Product Code
DWA  
Date Received01/29/2007
Decision Date 05/22/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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