FDA 510(k) Application Details - K993704

Device Classification Name	Enteroscope And Accessories   More FDA Info for this Device
510(K) Number	K993704
Device Name	Enteroscope And Accessories
Applicant	FUJINON, INC. 399 PARK AVE. NEW YORK, NY 10022-4689 US Other 510(k) Applications for this Company
Contact	GARY ADLER 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	11/02/1999
Decision Date	02/11/2000
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