FDA 510(k) Application Details - K140945

Device Classification Name	Catheter, Straight   More FDA Info for this Device
510(K) Number	K140945
Device Name	Catheter, Straight
Applicant	COMPACTCATH INC 3924 CASCADE BEACH ROAD LUTSEN, MN 55612 US Other 510(k) Applications for this Company
Contact	GREGORY MATHISON 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	04/14/2014
Decision Date	08/22/2014
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