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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 K971571
Device Name RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT
Applicant
WATERS INSTRUMENTS, INC.
2411 SEVENTH ST. N.W.
P.O. BOX 6117
ROCHESTER,  MN  55903 -6117
Applicant Contact DAVE SCHOLLMAN
Correspondent
WATERS INSTRUMENTS, INC.
2411 SEVENTH ST. N.W.
P.O. BOX 6117
ROCHESTER,  MN  55903 -6117
Correspondent Contact DAVE SCHOLLMAN
Regulation Number876.5880
Classification Product Code
KDN  
Date Received04/30/1997
Decision Date 07/29/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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