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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K220588
Device Name Avanos* CORTRAK* 2 Enteral Access System (EAS)
Applicant
Avanos Medical, Inc.
5405 Windward Pkwy.
Alpharetta,  GA  30004
Applicant Contact Nikin Desai
Correspondent
Avanos Medical, Inc.
5405 Windward Pkwy.
Alpharetta,  GA  30004
Correspondent Contact Angela Cushman
Regulation Number876.5980
Classification Product Code
KNT  
Date Received03/01/2022
Decision Date 04/22/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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