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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Radiofrequency Lesion
510(k) Number K203066
Device Name COOLIEF Cooled Radiofrequency Kit Advanced
Applicant
Avanos Medical, Inc.
5405 Windward Parkway, Suite 100
Alpharetta,  GA  30004
Applicant Contact Christian Supina
Correspondent
Accelerated Device Approval Services
6800 S.W. 40th Street, Ste. 403
Ludlum,  FL  33155
Correspondent Contact Rafael Aguila
Regulation Number882.4725
Classification Product Code
GXI  
Date Received10/09/2020
Decision Date 12/22/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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