FDA 510(k) Application Details - K023344

Device Classification Name	Tubes, Gastrointestinal (And Accessories)   More FDA Info for this Device
510(K) Number	K023344
Device Name	Tubes, Gastrointestinal (And Accessories)
Applicant	BOWEL MANAGEMENT SYSTEMS, LLC 1886 SOUTH 14TH ST. SUITE 6 FERNANDINA BEACH, FL 32034 US Other 510(k) Applications for this Company
Contact	CHAD A COBERLY 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	10/07/2002
Decision Date	11/06/2002
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