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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enteral Syringes With Enteral Specific Connectors
510(k) Number K142128
Device Name KANGAROO ENTERAL FEEDING SYRINGES WITH ENFIT CONNECTOR
Applicant
COVIDIEN
15 HAMPSHIRE STREET
MANSFIELD,  MA  02048
Applicant Contact SHANNON GREEN
Correspondent
COVIDIEN
15 HAMPSHIRE STREET
MANSFIELD,  MA  02048
Correspondent Contact SHANNON GREEN
Regulation Number876.5980
Classification Product Code
PNR  
Date Received08/04/2014
Decision Date 02/23/2015
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
Predetermined Change
Control Plan Authorized		 No
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