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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 K002033
Device Name BD INSYTE AUTOGUARD -P AND BD INSYTE AUTOGUARD -P WINGED IV CATHETERS
Applicant
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
9450 SOUTH STATE ST.
SANDY,  UT  84070
Applicant Contact LESLIE WOOD
Correspondent
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
9450 SOUTH STATE ST.
SANDY,  UT  84070
Correspondent Contact LESLIE WOOD
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received07/05/2000
Decision Date 07/26/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Special
Reviewed by Third Party No
Combination Product No
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