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510(k) K233021

BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device by Care Fusion — Product Code LHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 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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