Gabriel Feeding Tube With Balloon, And EnFit Connector

Gastrointestinal Tubes With Enteral Specific Connectors

Syncro Medical Innovations, Inc.

The following data is part of a premarket notification filed by Syncro Medical Innovations, Inc. with the FDA for Gabriel Feeding Tube With Balloon, And Enfit Connector.

Pre-market Notification Details

Device IDK191784
501k NumberK191784
Device Name:Gabriel Feeding Tube With Balloon, And EnFit Connector
ClassificationGastrointestinal Tubes With Enteral Specific Connectors
Applicant Syncro Medical Innovations, Inc. 515 Mulberry St Suite 200 Macon,  GA  31201 -6308
ContactSabry Gabriel
CorrespondentSabry Gabriel
Syncro Medical Innovations, Inc. 515 Mulberry St Suite 200 Macon,  GA  31201 -6308
Product CodePIF  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical SpecialtyGastroenterology/Urology
501k Review PanelGastroenterology/Urology
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2019-07-03
Decision Date2019-11-15

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