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510(k) K232987

FlowArt Valve for Vial Access by Asset Medikal Tasarim Sanayi VE Ticaret A.S. — Product Code LHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2024
Date Received
September 22, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, I.V. Fluid Transfer
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

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