FDA 510(k) Application Details - K191340

Device Classification Name	Tubes, Gastrointestinal (And Accessories)   More FDA Info for this Device
510(K) Number	K191340
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	Monica King 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	05/20/2019
Decision Date	06/04/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	Y
Expedited Review