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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, long-term greater than 30 days
510(k) Number K051194
Device Name BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER, MODELS 384647, 384667, 384687, 384648, 384668, 384688, 384649, 384669
Applicant
BECTON DICKINSON & CO.
9450 SOUTH STATE STREET
SANDY,  UT  84070
Applicant Contact LESLIE WOOD
Correspondent
BECTON DICKINSON & CO.
9450 SOUTH STATE STREET
SANDY,  UT  84070
Correspondent Contact LESLIE WOOD
Regulation Number880.5970
Classification Product Code
LJS  
Date Received05/10/2005
Decision Date 07/25/2005
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
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