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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 K933713
Device Name VENOUS RESERVIOR/CARDIOTOMY AUTOTRANSFUSION FILTER WITH DURAFLO II HEPARIN TREATMENT
Applicant
Baxter Healthcare Corp
17511 Armstrong Ave.
P.O.Box 19522
Irvine,  CA  92713 -9522
Applicant Contact LORI GLASTETTER
Correspondent
Baxter Healthcare Corp
17511 Armstrong Ave.
P.O.Box 19522
Irvine,  CA  92713 -9522
Correspondent Contact LORI GLASTETTER
Regulation Number870.4400
Classification Product Code
DTN  
Subsequent Product Code
DTP  
Date Received07/30/1993
Decision Date 03/01/1994
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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