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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 K172204
Device Name BD Intima II PLUS Closed IV Catheter System
Applicant
Becton, Dickinson and Company
9450 S. State St.
Sandy,  UT  84070
Applicant Contact Henry Boland
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received07/21/2017
Decision Date 08/17/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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