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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, perfusion, kidney, disposable
510(k) Number K121736
Device Name PERF-GEN PULSATILE PERFUSION SOLUTION
Applicant
WATERS MEDICAL SYSTEMS, LLC
2112 15TH ST. N.W.
ROCHESTER,  MN  55901
Applicant Contact ROBERT WARREN
Correspondent
WATERS MEDICAL SYSTEMS, LLC
2112 15TH ST. N.W.
ROCHESTER,  MN  55901
Correspondent Contact ROBERT WARREN
Regulation Number876.5880
Classification Product Code
KDL  
Date Received06/13/2012
Decision Date 08/16/2013
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
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