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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 K241185
Device Name CORGRIP* SR NG/NI Tube Retention System
Applicant
Avanos Medical, Inc.
5404 Windward Parkway
Alpharetta,  GA  30004
Applicant Contact Lauren Prock
Correspondent
Avanos Medical, Inc.
5404 Windward Parkway
Alpharetta,  GA  30004
Correspondent Contact Lauren Prock
Regulation Number876.5980
Classification Product Code
KNT  
Date Received04/29/2024
Decision Date 10/25/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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