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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 K142635
Device Name Medline Silicone Foley Catheter
Applicant
MEDLINE INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDLELEIN,  IL  60060
Applicant Contact Matt Clausen
Correspondent
MEDLINE INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDLELEIN,  IL  60060
Correspondent Contact Matt Clausen
Regulation Number876.5130
Classification Product Code
EZL  
Date Received09/17/2014
Decision Date 01/09/2015
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
Recalls CDRH Recalls
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