FDA 510(k) Application Details - K191440

Device Classification Name	System, Perfusion, Kidney   More FDA Info for this Device
510(K) Number	K191440
Device Name	System, Perfusion, Kidney
Applicant	Paragonix Technologies Suite 408, 639 Granite St. Braintree, MA 02184 US Other 510(k) Applications for this Company
Contact	Lisa M. Anderson 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	05/30/2019
Decision Date	12/20/2019
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