FDA 510(k) Application Details - K240650

Device Classification Name	System, Perfusion, Kidney   More FDA Info for this Device
510(K) Number	K240650
Device Name	System, Perfusion, Kidney
Applicant	Traferox Technologies Inc. 3505 Laird Rd. Unit 16 Mississauga L5L5Y7 CA Other 510(k) Applications for this Company
Contact	Nicole Baker Other 510(k) Applications for this Contact
Regulation Number	876.5880   More FDA Info for this Regulation Number
Classification Product Code	KDN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/07/2024
Decision Date	11/26/2024
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