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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name gastrointestinal tubes with enteral specific connectors
510(k) Number K143018
Device Name Kangaroo Enteral Feeding Tube Extension Set with ENFit Small Bore Connectors
Applicant
Covidien
15 Hampshire Street
Mansfeild,  MA  02048
Applicant Contact Wei Zhao
Correspondent
Covidien
15 Hampshire Street
Mansfeild,  MA  02048
Correspondent Contact Wei Zhao
Regulation Number876.5980
Classification Product Code
PIF  
Date Received10/20/2014
Decision Date 04/02/2015
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
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