Gabriel 3 Way EnFit Valve

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 3 Way Enfit Valve.

Pre-market Notification Details

Device IDK201741
510k NumberK201741
Device Name:Gabriel 3 Way EnFit Valve
ClassificationGastrointestinal Tubes With Enteral Specific Connectors
Applicant Syncro Medical Innovations, Inc. 515 Mulberry Street Macon,  GA  31201 -6308
ContactSabry Gabriel
CorrespondentSabry Gabriel
Syncro Medical Innovations, Inc. 515 Mulberry Street Macon,  GA  31201 -6308
Product CodePIF  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-25
Decision Date2020-11-05

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