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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Access Overtube, Gastroenterology-Urology
510(k) Number K030438
Device Name BARD AQUAGUIDE URETERAL CONDUIT
Applicant
C.R. Bard, Inc.
8195 Industrial Blvd.
Covington,  GA  30014
Applicant Contact FRAN HARRISON
Correspondent
Citech
5200 Butler Pike
Plymouth Meeting,  PA  19462
Correspondent Contact ROBERT MOSENKIS
Regulation Number876.1500
Classification Product Code
FED  
Date Received02/11/2003
Decision Date 03/17/2003
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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