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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 K200891
Device Name BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System
Applicant
Becton, Dickinson and Company
9450 South State Street
Sandy,  UT  84070
Applicant Contact Kimberly Geisler
Correspondent
Becton, Dickinson and Company
9450 South State Street
Sandy,  UT  84070
Correspondent Contact Kimberly Geisler
Regulation Number880.5200
Classification Product Code
FOZ  
Subsequent Product Code
FPA  
Date Received04/03/2020
Decision Date 06/02/2021
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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