FDA 510(k) Application Details - K150711

Device Classification Name	More FDA Info for this Device
510(K) Number	K150711
Device Name	Salem Sump Dual Lumen Stomach Tube with Multi-functional Port
Applicant	COVIDIEN 15 HAMPSHIRE STREET MANSFILED, MA 02048 US Other 510(k) Applications for this Company
Contact	Jim Welsh 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	03/19/2015
Decision Date	10/08/2015
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