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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 K111521
Device Name WAVES
Applicant
Waters Medical Systems, LLC
2112 15th St. NW, Suite A
Rochester,  MN  55901
Applicant Contact ROBERT WARREN
Correspondent
Waters Medical Systems, LLC
2112 15th St. NW, Suite A
Rochester,  MN  55901
Correspondent Contact ROBERT WARREN
Regulation Number876.5880
Classification Product Code
KDN  
Date Received06/01/2011
Decision Date 02/16/2012
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
Recalls CDRH Recalls
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