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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, urethral
510(k) Number K163179
Device Name Onli Intermittent Catheter
Applicant
HOLLISTER INCORPORATED
2000 HOLLISTER DRIVE
LIBERTYVILLE,  IL  60048
Applicant Contact JEANNE LEE
Correspondent
HOLLISTER INCORPORATED
2000 HOLLISTER DRIVE
LIBERTYVILLE,  IL  60048
Correspondent Contact JEANNE LEE
Regulation Number876.5130
Classification Product Code
GBM  
Date Received11/14/2016
Decision Date 01/26/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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