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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 K240940
Device Name Vial2Bag Advanced® 20mm Admixture Device
Applicant
West Pharmaceutical Services, Inc.
530 Herman O. W. Dr.
Exton,  PA  19431
Applicant Contact Fred Cowdery
Correspondent
West Pharmaceutical Services, Inc.
530 Herman O. W. Dr.
Exton,  PA  19431
Correspondent Contact Fred Cowdery
Regulation Number880.5440
Classification Product Code
LHI  
Date Received04/05/2024
Decision Date 05/03/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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