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FDA 510(k) Application Details - K073339
Device Classification Name
Set, Blood Transfusion
More FDA Info for this Device
510(K) Number
K073339
Device Name
Set, Blood Transfusion
Applicant
FENWAL, INC.
THREE CORPORATE DRIVE
LAKE ZURICH, IL 60047 US
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Contact
TAMMY DAVIS
Other 510(k) Applications for this Contact
Regulation Number
880.5440
More FDA Info for this Regulation Number
Classification Product Code
BRZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/28/2007
Decision Date
03/03/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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