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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name infusion safety management software
510(k) Number K141474
Device Name BECTON DICKINSON INTELLIPORT SYSTEM
Applicant
BECTON DICKINSON & CO.
11665 AVENA PLACE, SUITE 203
SAN DIEGO,  CA  92128
Applicant Contact DANIEL OLIVIER
Correspondent
BECTON DICKINSON & CO.
11665 AVENA PLACE, SUITE 203
SAN DIEGO,  CA  92128
Correspondent Contact DANIEL OLIVIER
Regulation Number880.5725
Classification Product Code
PHC  
Subsequent Product Code
FPA  
Date Received06/03/2014
Decision Date 12/18/2014
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
Recalls CDRH Recalls
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