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510(k) K121613

AGILIA INFUSION SYSTEM by Fresenius Kabi AG — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2013
Date Received
June 1, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

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