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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Ablation, Microwave And Accessories
510(k) Number K193232
Device Name Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology
Applicant
Covidien LLC
6135 Gunbarrel Ave
Boulder,  CO  80301
Applicant Contact Hilla Debby
Correspondent
Covidien LLC
6135 Gunbarrel Ave
Boulder,  CO  80301
Correspondent Contact Hilla Debby
Regulation Number878.4400
Classification Product Code
NEY  
Date Received11/25/2019
Decision Date 02/13/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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