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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 K180781
Device Name Bard Vertus Foley Catheter
Applicant
C. R. Bard, Inc.
8195 Industrial Blvd.
Covington,  GA  30014
Applicant Contact Sharon Lambert
Correspondent
C. R. Bard, Inc.
8195 Industrial Blvd.
Covington,  GA  30014
Correspondent Contact Sharon Lambert
Regulation Number876.5130
Classification Product Code
EZL  
Date Received03/26/2018
Decision Date 09/19/2018
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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