510(k) K213513

Vented Vial Adapter 20mm by West Pharma Services Il, Ltd. — Product Code LHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2022
Date Received
November 2, 2021
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