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 Other 510(k) Applications for this Company
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