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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Retention Type, Balloon
510(k) Number K951103
Device Name SILASTIC BRAND FOLEY CATHETER
Applicant
C.R. Bard, Inc.
C.R. Bard, Inc.
8195 Industrial Blvd.
Covington,  GA  30209
Applicant Contact CAROL VIERLING
Correspondent
C.R. Bard, Inc.
C.R. Bard, Inc.
8195 Industrial Blvd.
Covington,  GA  30209
Correspondent Contact CAROL VIERLING
Regulation Number876.5130
Classification Product Code
EZL  
Date Received03/10/1995
Decision Date 04/28/1995
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
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