FDA 510(k) Application Details - K012113

Device Classification Name	Tubes, Gastrointestinal (And Accessories)   More FDA Info for this Device
510(K) Number	K012113
Device Name	Tubes, Gastrointestinal (And Accessories)
Applicant	BOWEL MANAGEMENT SYSTEMS, LLC 7992 CASTEWAY DR. INDIANAPOLIS, IN 46250 US Other 510(k) Applications for this Company
Contact	COLLEEN J HITTLE Other 510(k) Applications for this Contact
Regulation Number	876.5980   More FDA Info for this Regulation Number
Classification Product Code	KNT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/06/2001
Decision Date	05/03/2002
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