510(k) K053169

Device: RM3 RENAL PRESERVATION SYSTEM
Applicant: WATERS INSTRUMENTS, INC.
510(k) number: K053169
Product code: KDK
Decision: Substantially Equivalent (SESE)
Decision date: 2006-01-17
Date received: 2005-11-14
Regulation: 876.5880
Classification name: Container, Transport, Kidney
Medical specialty: Gastroenterology/Urology
Review panel: Gastroenterology/Urology
Device class: 2
Clearance type: Special
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: DAVE SCHOLLMAN
Address: 2112 15th St. NW, Suite A Rochester MN US 55901 55901

Source Documents#

Other 510(k) Records For Product Code KDK #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K911577	HYPOTRANS MODEL 750	Martin Mclane Medical	1992-07-08
K801899	KEITHLEY LYMPHOCYTE DEPLETION CART	Keithley Development Co.	1980-09-26

Legacy Summary#

summary

FDA Review#

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