FDA 510(k) Application Details - K170279

Device Classification Name	Injector And Syringe, Angiographic   More FDA Info for this Device
510(K) Number	K170279
Device Name	Injector And Syringe, Angiographic
Applicant	Union Medical Shenzhen Co., Ltd. Room 603, Building 3, Fantasia MIC Plaza, Nanhai Avenue Nanshan District Shenzhen 518062 CN Other 510(k) Applications for this Company
Contact	Wenguo Zhang 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	01/30/2017
Decision Date	12/12/2017
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