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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name container, transport, kidney
510(k) Number K053169
Device Name RM3 RENAL PRESERVATION SYSTEM
Applicant
WATERS INSTRUMENTS, INC.
2112 15TH ST. N.W., SUITE A
ROCHESTER,  MN  55901
Applicant Contact DAVE SCHOLLMAN
Correspondent
WATERS INSTRUMENTS, INC.
2112 15TH ST. N.W., SUITE A
ROCHESTER,  MN  55901
Correspondent Contact DAVE SCHOLLMAN
Regulation Number876.5880
Classification Product Code
KDK  
Subsequent Product Code
KDN  
Date Received11/14/2005
Decision Date 01/17/2006
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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