ENvizion Medical ENvue; 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; Envizion Medical Enteral Feeding Tube.

Pre-market Notification Details

Device IDK182915
510k NumberK182915
Device Name:ENvizion Medical ENvue; 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  59874
Product CodeKNT  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-10-18
Decision Date2019-02-13
Summary:summary

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