FDA 510(k) Application Details - K043044

Device Classification Name	Tubes, Gastrointestinal (And Accessories)   More FDA Info for this Device
510(K) Number	K043044
Device Name	Tubes, Gastrointestinal (And Accessories)
Applicant	VIASYS MEDSYSTEMS 100 CHADDICK DR. WHEELING, IL 60090 US Other 510(k) Applications for this Company
Contact	STEPHANIE WASIELEWSKI 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	11/04/2004
Decision Date	05/06/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review