FDA 510(k) Application Details - K100878

Device Classification Name	Catheter, Straight   More FDA Info for this Device
510(K) Number	K100878
Device Name	Catheter, Straight
Applicant	COLOPLAST MANUFACTURING US, LLC 1601 WEST RIVER ROAD MINNEAPOLIS, MN 55411 US Other 510(k) Applications for this Company
Contact	BRIAN SCHMIDT Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	EZD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/30/2010
Decision Date	05/26/2010
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