FDA 510(k) Application Details - K040110

Device Classification Name	Rod, Colostomy   More FDA Info for this Device
510(K) Number	K040110
Device Name	Rod, Colostomy
Applicant	TOOLS FOR SURGERY, LLC 1339 STONY BROOK ROAD STONY BROOK, NY 11790 US Other 510(k) Applications for this Company
Contact	ARNOLD R LEIBOFF 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	01/20/2004
Decision Date	03/24/2004
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