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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 K072549
Device Name TITANIUM POWERPORT ISP IMPLANTED PORT WITH 6 FR CHRONOFLEX POLYURETHANE CATHETER
Applicant
C.R. BARD, INC.
605 N 5600 W
SALT LAKE CITY,  UT  84116
Applicant Contact SUSAN D SCOTT
Correspondent
C.R. BARD, INC.
605 N 5600 W
SALT LAKE CITY,  UT  84116
Correspondent Contact SUSAN D SCOTT
Regulation Number880.5965
Classification Product Code
LJT  
Date Received09/10/2007
Decision Date 11/14/2007
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
Recalls CDRH Recalls
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