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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 K090512
Device Name POWERPORT DUO M.R.I. IMPLANTED PORT WITH 9.5 FR. DUAL LUMEN CHRONOFLEX POLYURETHANE CATHETER
Applicant
C.R. Bard, Inc.
605 N. 5600 W.
Salt Lake Ciy,,  UT  84116
Applicant Contact ANGELA M BRADY
Correspondent
C.R. Bard, Inc.
605 N. 5600 W.
Salt Lake Ciy,,  UT  84116
Correspondent Contact ANGELA M BRADY
Regulation Number880.5965
Classification Product Code
LJT  
Date Received02/26/2009
Decision Date 03/27/2009
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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