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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 K854133
Device Name BIO MEDICUS BIO CONSOLE 540
Applicant
Bio Medicus, Inc.
9600 W. 76 St.
Eden Prairie,  MN  55344
Applicant Contact JOHN R DALPEE
Correspondent
Bio Medicus, Inc.
9600 W. 76 St.
Eden Prairie,  MN  55344
Correspondent Contact JOHN R DALPEE
Regulation Number870.4380
Classification Product Code
DWA  
Date Received10/10/1985
Decision Date 01/08/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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