FDA 510(k) Application Details - K233277

Device Classification Name	Filter, Infusion Line   More FDA Info for this Device
510(K) Number	K233277
Device Name	Filter, Infusion Line
Applicant	Hangzhou Qiantang Longyue Biotechnology Co., LTD 104, 301, 302, building 12, building 1,619 WangMei Roadinping Street, Linping District Hangzhou 311199 CN Other 510(k) Applications for this Company
Contact	Chunyu Wang Other 510(k) Applications for this Contact
Regulation Number	880.5440   More FDA Info for this Regulation Number
Classification Product Code	FPB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2023
Decision Date	05/10/2024
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