Emprint Ablation System With Thermosphere Technology

System, Ablation, Microwave And Accessories

Covidien LLC

The following data is part of a premarket notification filed by Covidien Llc with the FDA for Emprint Ablation System With Thermosphere Technology.

Pre-market Notification Details

Device IDK200796
510k NumberK200796
Device Name:Emprint Ablation System With Thermosphere Technology
ClassificationSystem, Ablation, Microwave And Accessories
Applicant Covidien LLC 5920 Longbow Drive Boulder,  CO  80301
ContactLiron Bar Yaakov
CorrespondentLiron Bar Yaakov
Covidien LLC 5920 Longbow Drive Boulder,  CO  80301
Product CodeNEY  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-26
Decision Date2020-08-26

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