FDA 510(k) Application Details - K151728

Device Classification Name	System, Perfusion, Kidney   More FDA Info for this Device
510(K) Number	K151728
Device Name	System, Perfusion, Kidney
Applicant	PRESERVATION SOLUTIONS, INC. 1099 PROCTOR DRIVE ELKHORN, WI 53121 US Other 510(k) Applications for this Company
Contact	GARY SWANSON 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	06/26/2015
Decision Date	09/18/2015
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