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510(k) K230464

MixJect® Transfer Device by West Pharma Services Il, Ltd. — Product Code LHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2023
Date Received
February 21, 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

Other clearances by West Pharma Services Il, Ltd.

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  • K232875 — Vial Adapter 20mm (December 14, 2023)
  • K230988 — Vial2Bag Advanced® 13mm Admixture Device (December 1, 2023)
  • K213513 — Vented Vial Adapter 20mm (August 31, 2022)

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