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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 K121618
Model BEL-GEN/US
Device Name BEL-GEN COLD STORAGE 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  
Subsequent Product Code
KDN  
Date Received06/01/2012
Decision Date 06/14/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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