FDA 510(k) Application Details - K213174

Device Classification Name	More FDA Info for this Device
510(K) Number	K213174
Device Name	Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection
Applicant	Cardinal Health 3651 Birchwood Drive Waukegan, IL 60085 US Other 510(k) Applications for this Company
Contact	Nivedita Namjoshi Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PIF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2021
Decision Date	05/19/2022
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