FDA 510(k) Application Details - K121833

Device Classification Name	Irrigator, Ostomy   More FDA Info for this Device
510(K) Number	K121833
Device Name	Irrigator, Ostomy
Applicant	COLOPLAST A/S 1601 WEST RIVER ROAD N MINNEAPOLIS, MN 55411 US Other 510(k) Applications for this Company
Contact	TIM CRABTREE Other 510(k) Applications for this Contact
Regulation Number	876.5895   More FDA Info for this Regulation Number
Classification Product Code	EXD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/22/2012
Decision Date	07/16/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review