K-number	K200796
Device name	Emprint Ablation System with Thermosphere Technology
Applicant	Covidien, LLC
Product code	NEY
Device class	Class II
Decision date	Aug 26, 2020
Decision	Substantially Equivalent
Regulation	878.4400

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Source

View the full FDA submission: accessdata.fda.gov

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Emprint Ablation System with Thermosphere Technology

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