Vial2Bag Advanced 20mm Admixture Device

Set, I.v. Fluid Transfer

West Pharmaceutical Services AZ, Inc.

The following data is part of a premarket notification filed by West Pharmaceutical Services Az, Inc. with the FDA for Vial2bag Advanced 20mm Admixture Device.

Pre-market Notification Details

Device IDK201415
510k NumberK201415
Device Name:Vial2Bag Advanced 20mm Admixture Device
ClassificationSet, I.v. Fluid Transfer
Applicant West Pharmaceutical Services AZ, Inc. 14677 North 74th Street Scottsdale,  AZ  85260
ContactElena Mack
CorrespondentDi Wu
West Pharmaceutical Services, Inc. 530 Herman O West Drive Exton,  PA  19341
Product CodeLHI  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-29
Decision Date2020-10-21

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