FDA 510(k) Application Details - K102648

Device Classification Name	Syringe, Balloon Inflation   More FDA Info for this Device
510(K) Number	K102648
Device Name	Syringe, Balloon Inflation
Applicant	SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD BLDG 11 LISHAN INDUSTRIAL PARK XINGHAI AVE, NANSHAN DISTRICT SHENZHEN, GUANGDONG 518052 CN Other 510(k) Applications for this Company
Contact	LYNN FU 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	09/14/2010
Decision Date	07/01/2011
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