FDA 510(k) Application Details - K040048

Device Classification Name	Enteroscope And Accessories   More FDA Info for this Device
510(K) Number	K040048
Device Name	Enteroscope And Accessories
Applicant	FUJINON, INC. P.O. BOX 2156 HUNTINGTON, CT 06484 US Other 510(k) Applications for this Company
Contact	JOSEPH M AZARY Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FDA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/12/2004
Decision Date	06/07/2004
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