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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
Original Applicant
WATERS MEDICAL SYSTEMS, LLC
2112 15th st. n.w.
rochester,  MN  55901
Original 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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