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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, administration, intravascular
510(k) Number K160651
Device Name BD FlowSmart Set, MiniMed Pro-Set
Applicant
BECTON, DICKINSON AND COMPANY
1 BECTON DRIVE
Franklin Lakes,  NJ  07666
Applicant Contact Matthew Trachtenberg
Correspondent
BECTON, DICKINSON AND COMPANY
1 BECTON DRIVE
Franklin Lakes,  NJ  07666
Correspondent Contact Matthew Trachtenberg
Regulation Number880.5440
Classification Product Code
FPA  
Subsequent Product Code
FPK  
Date Received03/08/2016
Decision Date 04/07/2016
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
Recalls CDRH Recalls
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