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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 K984084
Device Name BARDEX LUBRI-SIL FOLEY CATHETER
Applicant
BARD MEDICAL DIV.
8195 INDUSTRIAL BLVD.
COVINGTON,  GA  30014
Applicant Contact DONNA J WILSON
Correspondent
BARD MEDICAL DIV.
8195 INDUSTRIAL BLVD.
COVINGTON,  GA  30014
Correspondent Contact DONNA J WILSON
Regulation Number876.5130
Classification Product Code
EZL  
Date Received11/16/1998
Decision Date 02/01/1999
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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