FDA 510(k) Application Details - K092250

Device Classification Name	Catheter, Ureteral, Gastro-Urology   More FDA Info for this Device
510(K) Number	K092250
Device Name	Catheter, Ureteral, Gastro-Urology
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	876.5130   More FDA Info for this Regulation Number
Classification Product Code	EYB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/28/2009
Decision Date	01/21/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review