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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, administration, intravascular
510(K) Number K050207
Device Name BD POSIFLOW POSITIVE DISPLACEMENT VALVE
Applicant
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
9450 south state st.
sandy,  UT  84070
Contact leslie wood
Regulation Number880.5440
Classification Product Code
FPA  
Date Received01/28/2005
Decision Date 04/07/2005
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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