FDA 510(k) Application Details - K083349

Device Classification Name	Set, Blood Transfusion   More FDA Info for this Device
510(K) Number	K083349
Device Name	Set, Blood Transfusion
Applicant	SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS STE.8D, ZHONGXIN ZHONGSHAN MANSION,NO.19, LANE 999, ZHONG SHAN NAN ER RD., SHANGHAI 200030 CN Other 510(k) Applications for this Company
Contact	Diana Hong 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	11/13/2008
Decision Date	04/10/2009
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