FDA 510(k) Application Details - K140943

Device Classification Name	Syringe, Balloon Inflation   More FDA Info for this Device
510(K) Number	K140943
Device Name	Syringe, Balloon Inflation
Applicant	BEIJING DEMAX MEDICAL TECHNOLOGY CO., LTD. 7TH FLOOR, JINGUI BUSINESS BUILDING, NO 982, CONGYUN ROAD BAIYUN DISTRICT GUANGZHOU 510420 CN Other 510(k) Applications for this Company
Contact	MIKE GU Other 510(k) Applications for this Contact
Regulation Number	870.1650   More FDA Info for this Regulation Number
Classification Product Code	MAV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/14/2014
Decision Date	03/05/2015
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