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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 (antimicrobial) and accessories
510(k) Number K040658
Device Name BARDEX I.C. LATEX FOLEY CATHETER
Applicant
C.R. BARD, INC.
8195 INDUSTRIAL BLVD.
COVINGTON,  GA  30014
Applicant Contact JOHN C KNORPP
Correspondent
C.R. BARD, INC.
8195 INDUSTRIAL BLVD.
COVINGTON,  GA  30014
Correspondent Contact JOHN C KNORPP
Regulation Number876.5130
Classification Product Code
MJC  
Date Received03/12/2004
Decision Date 09/29/2004
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
Recalls CDRH Recalls
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