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510(k) K213744

Avoset Infusion Pump System by Eitan Medical , Ltd. — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2023
Date Received
November 29, 2021
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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