FDA 510(k) Application Details - K190923

Device Classification Name	More FDA Info for this Device
510(K) Number	K190923
Device Name	Salem Sump Dual Lumen Stomach Tube with ENFit Connection
Applicant	Cardinal Health 777 West Street Mansfield, MA 02048 US Other 510(k) Applications for this Company
Contact	Alexis Erazo 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	04/09/2019
Decision Date	11/07/2019
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