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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stent, Ureteral
510(k) Number K022447
Device Name BARD ER URETERAL STENT WITH SUTURE
Applicant
C.R. Bard, Inc.
8195 Industrial Blvd.
Covington,  GA  30014
Applicant Contact DONNA J WILSON
Correspondent
Citech
5200 Butler Pike
Plymouth Meeting,  PA  19462 -1298
Regulation Number876.4620
Classification Product Code
FAD  
Date Received07/26/2002
Decision Date 01/23/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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