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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 K051748
Device Name HEMOGLIDE SERIES AND HEMOGLIDE STAR SERIES XK LONG-TERM HEMODIALYSIS CATHETERS
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 Number876.5540
Classification Product Code
MSD  
Date Received06/29/2005
Decision Date 08/12/2005
Decision Substantially Equivalent (SESE)
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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