FDA 510(k) Application Details - K073718

Device Classification Name	Tube, Gastro-Enterostomy   More FDA Info for this Device
510(K) Number	K073718
Device Name	Tube, Gastro-Enterostomy
Applicant	MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE MUNDELEIN, IL 60060 US Other 510(k) Applications for this Company
Contact	MATT CLAUSEN Other 510(k) Applications for this Contact
Regulation Number	876.5980   More FDA Info for this Regulation Number
Classification Product Code	KGC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/31/2007
Decision Date	03/19/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review