FDA 510(k) Application Details - K072696

Device Classification Name	Injector And Syringe, Angiographic   More FDA Info for this Device
510(K) Number	K072696
Device Name	Injector And Syringe, Angiographic
Applicant	SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD SUITE 8D, ZHONGXIN ZHONGSHAN NO.19, LANE 999 ZHONGSHAN NO.2 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	09/24/2007
Decision Date	05/02/2008
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