FDA 510(k) Application Details - K052229

Device Classification Name	Rod, Colostomy   More FDA Info for this Device
510(K) Number	K052229
Device Name	Rod, Colostomy
Applicant	COLOPLAST CORP. 1940 COMMERCE DR. NORTH MANKATO, MN 56003 US Other 510(k) Applications for this Company
Contact	ELIZABETH BOOTS Other 510(k) Applications for this Contact
Regulation Number	876.4270   More FDA Info for this Regulation Number
Classification Product Code	EZP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/16/2005
Decision Date	10/13/2006
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