FDA 510(k) Application Details - K221387

Device Classification Name	Set, Perfusion, Kidney, Disposable   More FDA Info for this Device
510(K) Number	K221387
Device Name	Set, Perfusion, Kidney, Disposable
Applicant	Institut Georges Lopez Parc Tertiaire du Bois Dieu, 1 Allee des Chevreuils Lissieu 69380 FR Other 510(k) Applications for this Company
Contact	Matthieu Porteau 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	05/13/2022
Decision Date	06/14/2022
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