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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 K110443
Device Name BD INSYTE AUTOGUARD BC
Applicant
Becton, Dickinson & CO
9450 S St.ate St.
Sandy,  UT  84070
Applicant Contact RAND PUGMIRE
Correspondent
Becton, Dickinson & CO
9450 S St.ate St.
Sandy,  UT  84070
Correspondent Contact RAND PUGMIRE
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received02/16/2011
Decision Date 07/19/2011
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
Predetermined Change
Control Plan Authorized		 No
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