FDA 510(k) Application Details - K201395

Device Classification Name	Injector And Syringe, Angiographic   More FDA Info for this Device
510(K) Number	K201395
Device Name	Injector And Syringe, Angiographic
Applicant	Youwo (Guangzhou) Medical Device Co., Ltd. Kaiyuan Avenue, High-Tech Industrial Development Zone Guangzhou 510530 CN Other 510(k) Applications for this Company
Contact	Meijin Song 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	05/27/2020
Decision Date	10/28/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review