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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 Ave. N, Suite 102
Plymouth,  MN  55441
Applicant Contact DAVE SCHOLLMAN
Correspondent
Waters Instruments, Inc.
13705 26th Ave. N, Suite 102
Plymouth,  MN  55441
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
Predetermined Change
Control Plan Authorized		 No
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