FDA 510(k) Application Details - K220588

Device Classification Name	Tubes, Gastrointestinal (And Accessories)   More FDA Info for this Device
510(K) Number	K220588
Device Name	Tubes, Gastrointestinal (And Accessories)
Applicant	Avanos Medical Inc 5405 Windward Parkway Alpharetta, GA 30004 US Other 510(k) Applications for this Company
Contact	Nikin Desai Other 510(k) Applications for this Contact
Regulation Number	876.5980   More FDA Info for this Regulation Number
Classification Product Code	KNT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/01/2022
Decision Date	04/22/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review