FDA 510(k) Application Details - K100366

Device Classification Name	Tubes, Gastrointestinal (And Accessories)   More FDA Info for this Device
510(K) Number	K100366
Device Name	Tubes, Gastrointestinal (And Accessories)
Applicant	MAXTER CATHETERS VILLAGE D'ENTREPRISES SAINT HENRI II, RUE ANNE GACON MARSEILLE 13016 FR Other 510(k) Applications for this Company
Contact	M. BERNARD DAURELLE 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	02/12/2010
Decision Date	06/14/2010
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