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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, perfusion, kidney
510(k) Number K042224
Device Name RM3 RENAL PRESERVATION SYSTEM
Applicant
WATERS INSTRUMENTS, INC.
13705 26TH AVENUE N.
SUITE 102
MINNEAPOLIS,  MN  55441 -3644
Applicant Contact DAVE SCHOLLMAN
Correspondent
WATERS INSTRUMENTS, INC.
13705 26TH AVENUE N.
SUITE 102
MINNEAPOLIS,  MN  55441 -3644
Correspondent Contact DAVE SCHOLLMAN
Regulation Number876.5880
Classification Product Code
KDN  
Date Received08/17/2004
Decision Date 10/22/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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