FDA 510(k) Application Details - K111521

Device Classification Name	System, Perfusion, Kidney   More FDA Info for this Device
510(K) Number	K111521
Device Name	System, Perfusion, Kidney
Applicant	WATERS MEDICAL SYSTEMS, LLC 2112 15TH ST. N.W., SUITE A ROCHESTER, MN 55901-0716 US Other 510(k) Applications for this Company
Contact	ROBERT WARREN 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	06/01/2011
Decision Date	02/16/2012
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