K-number	K240127
Device name	PlumeSafe X5 Smoke Management System
Applicant	Conmed Corporation
Product code	FYD
Device class	Class II
Decision date	Aug 5, 2024
Decision	Substantially Equivalent
Regulation	878.5070

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Source

View the full FDA submission: accessdata.fda.gov

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PlumeSafe X5 Smoke Management System

Everything you need for a 510(k) submission. Nothing you don't.