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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 K111366
Model 383590, 383591, 383592, 383593, 383594, 383691, 383692, 383693, 383694, 383695
Device Name BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM
Original Applicant
BECTON DICKINSON AND COMPANY (BD)
9450 south state street
sandy,  UT  84070
Original Contact rachel leblanc
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received05/16/2011
Decision Date 09/30/2011
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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