Kangaroo Enteral Feeding Tube Extension Set With ENFit Small Bore Connectors

Gastrointestinal Tubes With Enteral Specific Connectors

Covidien

The following data is part of a premarket notification filed by Covidien with the FDA for Kangaroo Enteral Feeding Tube Extension Set With Enfit Small Bore Connectors.

Pre-market Notification Details

Device IDK143018
510k NumberK143018
Device Name:Kangaroo Enteral Feeding Tube Extension Set With ENFit Small Bore Connectors
ClassificationGastrointestinal Tubes With Enteral Specific Connectors
Applicant Covidien 15 Hampshire Street Mansfeild,  MA  02048
ContactWei Zhao
CorrespondentWei Zhao
Covidien 15 Hampshire Street Mansfeild,  MA  02048
Product CodePIF  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-10-20
Decision Date2015-04-02
Summary:summary

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