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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
510(k) Number K883956
Device Name BIO-MEDICUS TUBING CONNECTORS
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 Number870.4290
Classification Product Code
DTL  
Date Received09/19/1988
Decision Date 10/28/1988
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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