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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, Non-Implanted
510(k) Number K030268
Device Name NIAGARA TEMPORARY DUAL LUMEN CATHETERS; FLEXXICON II TEMPORARY DUAL LUMEN CATHETERS
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
MPB  
Date Received01/27/2003
Decision Date 07/30/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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