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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, I.V. Fluid Transfer
510(k) Number K230988
Device Name Vial2Bag Advanced® 13mm Admixture Device
Applicant
West Pharma Services Il, Ltd.
4 Hasheizaf St.
Ra'Anana,  IL 4366411
Applicant Contact llanit Goldgraber
Correspondent
West Pharmaceutical Services, Inc.
530 Hermon O. W. Dr.
Exton,  PA  19341
Correspondent Contact Lynn Lundy
Regulation Number880.5440
Classification Product Code
LHI  
Date Received04/06/2023
Decision Date 12/01/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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