K-number	K210851
Device name	DiLumen Endolumenal Interventional Platform (DiLumen)
Applicant	Lumendi, LLC
Product code	FDF
Device class	Class II
Decision date	Apr 21, 2021
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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DiLumen Endolumenal Interventional Platform (DiLumen)

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