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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 K151698
Device Name BD Angiocath IV Catheter, BD Insyte IV Catheter
Applicant
Becton Dickinson Infusion Therapy Systems, Inc.
9450 S St.ate 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 Received06/24/2015
Decision Date 07/27/2015
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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