FDA 510(k) Application Details - K083785

Device Classification Name	Pouch, Colostomy   More FDA Info for this Device
510(K) Number	K083785
Device Name	Pouch, Colostomy
Applicant	CONVATEC 200 HEADQUARTERS PARK DR. SKILLMAN, NJ 08558 US Other 510(k) Applications for this Company
Contact	MARILYN KONICKY Other 510(k) Applications for this Contact
Regulation Number	876.5900   More FDA Info for this Regulation Number
Classification Product Code	EZQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/19/2008
Decision Date	04/02/2010
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