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510(k) K192869

SherpaPak Lung Preservation System , SherpaPak Liver Transport System by Pragonix Technologies — Product Code KDN

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
January 16, 2020
Date Received
October 7, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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