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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reservoir, Blood, Cardiopulmonary Bypass
510(k) Number K896414
Device Name VENOUS RESERVOIR BAG MODEL NO. BMR-800 W/HEPARIN
Applicant
Baxter Healthcare Corp
P.O. Box 19522
Irvine,  CA  92713
Applicant Contact DONALD A RAIBLE
Correspondent
Baxter Healthcare Corp
P.O. Box 19522
Irvine,  CA  92713
Correspondent Contact DONALD A RAIBLE
Regulation Number870.4400
Classification Product Code
DTN  
Date Received11/08/1989
Decision Date 01/31/1990
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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