FDA 510(k) Application Details - K023039

Device Classification Name	Set, Blood Transfusion   More FDA Info for this Device
510(K) Number	K023039
Device Name	Set, Blood Transfusion
Applicant	TUTA HEALTHCARE PTY LIMITED 318-332 BURNS BAY ROAD LANE COVE SYDNEY NSW 2066 AU Other 510(k) Applications for this Company
Contact	OMID SOURESRAFIL 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	09/12/2002
Decision Date	11/07/2002
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