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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
510(k) Number K852698
Device Name BIO MEDICUS BIO PUMP MODEL BP-80
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 Number870.4360
Classification Product Code
KFM  
Date Received06/26/1985
Decision Date 09/30/1985
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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