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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 K101261
Device Name CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
Applicant
C.R. Bard, Inc.
605 N. 5600 W.
Salt Lake Ciy,,  UT  84116
Applicant Contact Mark Nelson
Correspondent
C.R. Bard, Inc.
605 N. 5600 W.
Salt Lake Ciy,,  UT  84116
Correspondent Contact Mark Nelson
Regulation Number876.5540
Classification Product Code
NFK  
Date Received05/05/2010
Decision Date 07/29/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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