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510(k) K121736

PERF-GEN PULSATILE PERFUSION SOLUTION by Waters Medical Systems, LLC — Product Code KDL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2013
Date Received
June 13, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Perfusion, Kidney, Disposable
Device Class
Class II
Regulation Number
876.5880
Review Panel
GU
Submission Type

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