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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Repair, Catheter, Hemodialysis
510(k) Number K063446
Device Name CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
Applicant
C.R. Bard, Inc.
5425 W. Amelia Earhart Dr.
Salt Lake City,  UT  84116
Applicant Contact PEGGY KEIFFER
Correspondent
C.R. Bard, Inc.
5425 W. Amelia Earhart Dr.
Salt Lake City,  UT  84116
Correspondent Contact PEGGY KEIFFER
Regulation Number876.5540
Classification Product Code
NFK  
Date Received11/15/2006
Decision Date 12/15/2006
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
Predetermined Change
Control Plan Authorized		 No
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