FDA 510(k) Application Details - K211842

Device Classification Name	Set, Perfusion, Kidney, Disposable   More FDA Info for this Device
510(K) Number	K211842
Device Name	Set, Perfusion, Kidney, Disposable
Applicant	S.A.L.F. spa Via Marconi 2 Cenate Sotto 32069 IT Other 510(k) Applications for this Company
Contact	Carmelo Gagliano Other 510(k) Applications for this Contact
Regulation Number	876.5880   More FDA Info for this Regulation Number
Classification Product Code	KDL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/15/2021
Decision Date	12/20/2021
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