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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Blood Transfusion
510(k) Number K073339
Device Name BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR
Applicant
Fenwal, Inc.
Three Corporate Dr.
Lake Zurich,  IL  60047
Applicant Contact TAMMY DAVIS
Correspondent
Fenwal, Inc.
Three Corporate Dr.
Lake Zurich,  IL  60047
Correspondent Contact TAMMY DAVIS
Regulation Number880.5440
Classification Product Code
BRZ  
Date Received11/28/2007
Decision Date 03/03/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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