K-number	K243091
Device name	Over-tube (TR-1108A)
Applicant	Fujifilm Corporation
Product code	FED
Device class	Class II
Decision date	Nov 1, 2024
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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Over-tube (TR-1108A)

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