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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 K910318
Device Name BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETER
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
MJC  
Date Received01/24/1991
Decision Date 08/18/1994
Decision Substantially Equivalent (SESE)
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
Recalls CDRH Recalls
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