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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. NW
P.O. Box 6117
Rochester,  MN  55903
Applicant Contact DAVE SCHOLLMAN
Correspondent
Waters Instruments, Inc.
2411 Seventh St. NW
P.O. Box 6117
Rochester,  MN  55903
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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