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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 K181718
Device Name BD FlowSmart Set/MiniMed Pro-Set
Applicant
Becton, Dickinson and Company
1 Becton Drive
Franklin Lakes,  NJ  07417
Applicant Contact Meriam Youssef
Correspondent
Becton, Dickinson and Company
1 Becton Drive
Franklin Lakes,  NJ  07417
Correspondent Contact Meriam Youssef
Regulation Number880.5440
Classification Product Code
FPA  
Subsequent Product Code
FPK  
Date Received06/29/2018
Decision Date 10/18/2018
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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