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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tubes, gastrointestinal (and accessories)
510(k) Number K163002
Device Name Kangaroo Feeding Tube with IRIS Technology
Covidien (dba Medtronic)
15 Hampshire St
Mansfield,  MA  02048
Applicant Contact Alexis Erazo
Covidien (dba Medtronic)
15 Hampshire St
Mansfield,  MA  02048
Correspondent Contact Alexis Erazo
Regulation Number876.5980
Classification Product Code
Subsequent Product Code
Date Received10/28/2016
Decision Date 05/16/2017
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