K-number	K182915
Device name	ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube
Applicant	Envizion Medical , Ltd.
Product code	KNT
Device class	Class II
Decision date	Feb 13, 2019
Decision	Substantially Equivalent
Regulation	876.5980

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Source

View the full FDA submission: accessdata.fda.gov

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ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube

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