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 IDK203133
510k NumberK203133
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
CorrespondentJohn Mann
Evergreen Research, Inc. 433 Park Point Drive, Suite 140 Golden,  CO  80401
Product CodeKNT  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-19
Decision Date2021-03-24

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