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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Urological
510(k) Number K922527
Device Name BARD URODYNAMIC CATHETERIZATION PROCEDURE TRAY
Applicant
C.R. Bard, Inc.
8195 Industrial Blvd.
Covington,  GA  30014
Applicant Contact DONNA J WILSON
Correspondent
C.R. Bard, Inc.
8195 Industrial Blvd.
Covington,  GA  30014
Correspondent Contact DONNA J WILSON
Regulation Number876.5130
Classification Product Code
KOD  
Date Received05/28/1992
Decision Date 04/14/1994
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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