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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 K201415
Device Name Vial2Bag Advanced 20mm Admixture Device
Applicant
West Pharmaceutical Services AZ, Inc.
14677 North 74th Street
Scottsdale,  AZ  85260
Applicant Contact Elena Mack
Correspondent
West Pharmaceutical Services, Inc.
530 Herman O West Drive
Exton,  PA  19341
Correspondent Contact Di Wu
Regulation Number880.5440
Classification Product Code
LHI  
Date Received05/29/2020
Decision Date 10/21/2020
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
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