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510(k) K211224

RM4 Control Unit by Institut Georges Lopez — Product Code KDN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2021
Date Received
April 23, 2021
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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