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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 K150514
Device Name Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters
Applicant
C.R. Bard, Inc.
Salt Lake City,  UT  84116
Applicant Contact James R. Davis
Correspondent
C.R. Bard, Inc.
Bard Access Systems, Inc.
Salt Lake City,  UT  84116
Correspondent Contact James R. Davis
Regulation Number880.5965
Classification Product Code
LJT  
Date Received02/27/2015
Decision Date 11/20/2015
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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