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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 S St.ate St.
Sandy,  UT  84070
Applicant Contact LESLIE WOOD
Correspondent
Becton Dickinson Infusion Therapy Systems, Inc.
9450 S St.ate St.
Sandy,  UT  84070
Correspondent Contact LESLIE WOOD
Regulation Number880.5440
Classification Product Code
FPA  
Date Received01/28/2005
Decision Date 04/07/2005
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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