FDA 510(k) Application Details - K170027

Device Classification Name	Syringe, Balloon Inflation   More FDA Info for this Device
510(K) Number	K170027
Device Name	Syringe, Balloon Inflation
Applicant	SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD. NO. 925 JINYUAN YI RD SHANGHAI 201803 CN Other 510(k) Applications for this Company
Contact	Xu Jianhai 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	01/03/2017
Decision Date	10/06/2017
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