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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name port & catheter, implanted, subcutaneous, intravascular
510(k) Number K034065
Device Name MODIFICATION TO X-PORT DUO PORT
Applicant
C.R. BARD, INC.
5425 west amelia earhart dr.
salt lake city,  UT  84116
Applicant Contact angela brady
Correspondent
C.R. BARD, INC.
5425 west amelia earhart dr.
salt lake city,  UT  84116
Correspodent Contact angela brady
Regulation Number880.5965
Classification Product Code
LJT  
Date Received12/29/2003
Decision Date 01/15/2004
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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