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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 K191340
Device Name CORTRAK* 2 Equilateral Enteral Access System
Applicant
Avanos Medical, Inc.
5405 Windward Pkwy.
Alpharetta,  GA  30004
Applicant Contact Monica King
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number876.5980
Classification Product Code
KNT  
Date Received05/20/2019
Decision Date 06/04/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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