FDA 510(k) Application Details - K182819

Device Classification Name	Set, I.V. Fluid Transfer   More FDA Info for this Device
510(K) Number	K182819
Device Name	Set, I.V. Fluid Transfer
Applicant	Gcmedica Enterprise Ltd., (WUXI) Loujin Industrial Park, Shuofang Wuxi 214143 CN Other 510(k) Applications for this Company
Contact	Mona Zhang Other 510(k) Applications for this Contact
Regulation Number	880.5440   More FDA Info for this Regulation Number
Classification Product Code	LHI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/04/2018
Decision Date	12/02/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review