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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 K063377
Device Name POWERPORT POLYMETRIC PORT WITH 8 FR S/L CHRONOFLEX CATHETER
Applicant
C.R. BARD, INC.
5425 WEST AMELIA EARHART DR.
SALT LAKE CITY,  UT  84116
Applicant Contact MICHAELA RIVKOWICH
Correspondent
C.R. BARD, INC.
5425 WEST AMELIA EARHART DR.
SALT LAKE CITY,  UT  84116
Correspondent Contact MICHAELA RIVKOWICH
Regulation Number880.5965
Classification Product Code
LJT  
Date Received11/08/2006
Decision Date 01/25/2007
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
Recalls CDRH Recalls
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