FDA 510(k) Application Details - K222718

Device Classification Name	Set, I.V. Fluid Transfer   More FDA Info for this Device
510(K) Number	K222718
Device Name	Set, I.V. Fluid Transfer
Applicant	Hangzhou Qiantang Longyue Biotechnology Co., LTD 302,building 12, building 1,619 WangMei Road,Linping street, Linping DIstrict, Hangzhou Hangzhou 311199 CN Other 510(k) Applications for this Company
Contact	Zhengxu Xiang 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	09/08/2022
Decision Date	03/10/2023
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