K-number	K183112
Device name	DiLumen Endolumenal Interventional Knife (DiLumen IK)
Applicant	Lumendi, LLC
Product code	GEI
Device class	Class II
Decision date	Aug 2, 2019
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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DiLumen Endolumenal Interventional Knife (DiLumen IK)

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DiLumen Endolumenal Interventional Knife (DiLumen IK)