FDA 510(k) Application Details - K242479

Device Classification Name	Accessories, Blood Circuit, Hemodialysis   More FDA Info for this Device
510(K) Number	K242479
Device Name	Accessories, Blood Circuit, Hemodialysis
Applicant	Nikkiso Co., LTD. 20-3, Ebisu 4-Chome Shibuya-ku 150-6022 JP Other 510(k) Applications for this Company
Contact	Satoko Hina Other 510(k) Applications for this Contact
Regulation Number	876.5820   More FDA Info for this Regulation Number
Classification Product Code	KOC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/21/2024
Decision Date	05/15/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review