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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 K060812
Device Name POWERPORT(TM)IMPLANTED TITANIUM PORT W/8 FR. CHRONOFLEX CATHETER-MULTIPLE
Applicant
C.R. BARD, INC.
5425 WEST AMELIA EARHART DR.
SALT LAKE CITY,  UT  84116
Applicant Contact SUSAN SCOTT
Correspondent
C.R. BARD, INC.
5425 WEST AMELIA EARHART DR.
SALT LAKE CITY,  UT  84116
Correspondent Contact SUSAN SCOTT
Regulation Number880.5965
Classification Product Code
LJT  
Subsequent Product Code
FPA  
Date Received03/24/2006
Decision Date 07/14/2006
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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