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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 K150699
Device Name Bard LubriGuard Foley Catheter
Applicant
C.R. Bard, Inc.
8195 Industrial Blvd
Covington,  GA  30014
Applicant Contact Michele Davis
Correspondent
C.R. Bard, Inc.
8195 Industrial Blvd
Covington,  GA  30014
Correspondent Contact Michele Davis
Regulation Number876.5130
Classification Product Code
EZL  
Date Received03/18/2015
Decision Date 07/28/2015
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
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