K-number	K222880
Device name	Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)
Applicant	Endolumik, Inc.
Product code	KNT
Device class	Class II
Decision date	Mar 3, 2023
Decision	Substantially Equivalent
Regulation	876.5980

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Source

View the full FDA submission: accessdata.fda.gov

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Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)

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