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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion, Enteral
510(k) Number K153074
Device Name Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal
Applicant
COVIDIEN
15 HAMPSHIRE STREET
MANSFILED,  MA  02048
Applicant Contact Karin Desjardins
Correspondent
COVIDIEN
15 HAMPSHIRE STREET
MANSFILED,  MA  02048
Correspondent Contact Karin Desjardins
Regulation Number880.5725
Classification Product Code
LZH  
Date Received10/22/2015
Decision Date 07/06/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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