Salem Sump Dual Lumen Stomach Tube With ENFit Connection

Gastrointestinal Tubes With Enteral Specific Connectors

Cardinal Health

The following data is part of a premarket notification filed by Cardinal Health with the FDA for Salem Sump Dual Lumen Stomach Tube With Enfit Connection.

Pre-market Notification Details

Device IDK190923
501k NumberK190923
Device Name:Salem Sump Dual Lumen Stomach Tube With ENFit Connection
ClassificationGastrointestinal Tubes With Enteral Specific Connectors
Applicant Cardinal Health 777 West Street Mansfield,  MA  02048
ContactAlexis Erazo
CorrespondentAlexis Erazo
Cardinal Health 777 West Street Mansfield,  MA  02048
Product CodePIF  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGastroenterology/Urology
501k Review PanelGastroenterology/Urology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-09
Decision Date2019-11-07

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