FDA 510(k) Application Details - K053169

Device Classification Name	Container, Transport, Kidney   More FDA Info for this Device
510(K) Number	K053169
Device Name	Container, Transport, Kidney
Applicant	WATERS INSTRUMENTS, INC. 2112 15TH ST. N.W., SUITE A ROCHESTER, MN 55901 US Other 510(k) Applications for this Company
Contact	DAVE SCHOLLMAN Other 510(k) Applications for this Contact
Regulation Number	876.5880   More FDA Info for this Regulation Number
Classification Product Code	KDK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/14/2005
Decision Date	01/17/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review