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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 K033294
Device Name HEMOSPLIT XK, HEMOSPLIT XK CATHETER, 16FR X 42 CM, KIT;16FR X 19 CM, KIT WITH MICROINTRODUCER
Applicant
C.R. Bard, Inc.
5425 W. Amelia Earhart Dr.
Salt Lake City,  UT  84116
Applicant Contact GLENN NORTON
Correspondent
C.R. Bard, Inc.
5425 W. Amelia Earhart Dr.
Salt Lake City,  UT  84116
Correspondent Contact GLENN NORTON
Regulation Number876.5540
Classification Product Code
MSD  
Date Received10/14/2003
Decision Date 11/26/2003
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
Predetermined Change
Control Plan Authorized		 No
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