FDA 510(k) Application Details - K193005

Device Classification Name	Dialyzer, High Permeability With Or Without Sealed Dialysate System   More FDA Info for this Device
510(K) Number	K193005
Device Name	Dialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant	Dialco Medical Inc. 135 The West Mall, Unit 2 Toronto M9C1C2 CA Other 510(k) Applications for this Company
Contact	Danijela Domljanovic Other 510(k) Applications for this Contact
Regulation Number	876.5860   More FDA Info for this Regulation Number
Classification Product Code	KDI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/28/2019
Decision Date	08/28/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review