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510(k) K213089

Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector by Ivenix, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 2021
Date Received
September 24, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Ivenix, Inc.

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