FDA 510(k) Application Details - K082439

Device Classification Name	Injector And Syringe, Angiographic   More FDA Info for this Device
510(K) Number	K082439
Device Name	Injector And Syringe, Angiographic
Applicant	SHANDONG WEIGAO MEDICAL POLYMER CO., LTD SUITE 8D, NO.19, LANE 999, ZHONGSHAN NO.2 ROAD(S) SHANGHAI 200030 CN Other 510(k) Applications for this Company
Contact	Diana Hong Other 510(k) Applications for this Contact
Regulation Number	870.1650   More FDA Info for this Regulation Number
Classification Product Code	DXT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/25/2008
Decision Date	03/23/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review