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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K203150
Device Name Cool-tip RF Ablation System E Series
Applicant
Covidien, LLC
5920 Longbow Dr.
Boulder,  CO  80301
Applicant Contact Liron Bar Yaakov
Correspondent
Covidien, LLC
5920 Longbow Dr.
Boulder,  CO  80301
Correspondent Contact Liron Bar Yaakov
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/22/2020
Decision Date 02/25/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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