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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, therapeutic, short-term less than 30 days
510(k) Number K143610
Device Name BD INTIMA II CLOSED IV CATHETER
Applicant
Becton Dickinson Infusion Therapy Systems Inc.
9450 South State Street
Sandy,  UT  84070
Applicant Contact John Roberts
Correspondent
Becton Dickinson Infusion Therapy Systems Inc.
9450 South State Street
Sandy,  UT  84070
Correspondent Contact John Roberts
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received12/19/2014
Decision Date 04/09/2015
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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