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510(k) K170826

Perfadex Plus by Xvivo Perfusion AB — Product Code KDN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2018
Date Received
March 20, 2017
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

Other clearances by Xvivo Perfusion AB

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  • K091989 — PERFADEX AND PERFADEX WITH THAM (October 1, 2010)

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