FDA 510(k) Application Details - K182289

Device Classification Name	Injector And Syringe, Angiographic   More FDA Info for this Device
510(K) Number	K182289
Device Name	Injector And Syringe, Angiographic
Applicant	Shenzhen Baoan Medical Supplies Co., Ltd No.6, Shenkeng Road, Shenkeng Industrial Zone Liuyue Community, Henggang Shenzhen 518173 CN Other 510(k) Applications for this Company
Contact	Mingan Mu 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	08/23/2018
Decision Date	10/10/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review