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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Hemodialysis, Implanted
510(k) Number K090101
Device Name EQUISTREAM LONG-TERM HEMODIALYSIS CATHETERS
Applicant
C.R. BARD, INC.
605 N 5600 W
SALT LAKE CITY,  UT  84116
Applicant Contact JESSICA AGNELLO
Correspondent
C.R. BARD, INC.
605 N 5600 W
SALT LAKE CITY,  UT  84116
Correspondent Contact JESSICA AGNELLO
Regulation Number876.5540
Classification Product Code
MSD  
Date Received01/15/2009
Decision Date 02/10/2009
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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