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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 K853126
Device Name BIO PACK MODEL 200
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 Received07/25/1985
Decision Date 10/11/1985
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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