ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube

Tubes, Gastrointestinal (and Accessories)

Envizion Medical Ltd.

The following data is part of a premarket notification filed by Envizion Medical Ltd. with the FDA for Envizion Medical Envue System, Envizion Medical Enteral Feeding Tube.

Pre-market Notification Details

Device IDK191387
510k NumberK191387
Device Name:ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant Envizion Medical Ltd. 7 Haarad St. Tel Aviv,  IL 6971060
ContactDoron Besser
CorrespondentClay Anselmo
Shriner & Associates 429 Whitepine Creek Road Trout Creek,  MT  59872
Product CodeKNT  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-24
Decision Date2019-06-14

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