Vented Vial Adapter 20mm

Set, I.v. Fluid Transfer

West Pharma Services IL, Ltd.

The following data is part of a premarket notification filed by West Pharma Services Il, Ltd. with the FDA for Vented Vial Adapter 20mm.

Pre-market Notification Details

Device IDK213513
510k NumberK213513
Device Name:Vented Vial Adapter 20mm
ClassificationSet, I.v. Fluid Transfer
Applicant West Pharma Services IL, Ltd. 4 Hasheizaf St Ra'anana,  IL 4366411
ContactLlanit Goldgraber
CorrespondentFred Cowdery
West Pharmaceutical Services, Inc. 530 Hermon O. West Drive Exton,  PA  19341
Product CodeLHI  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-11-02
Decision Date2022-08-31

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