FDA 510(k) Application Details - K183032

Device Classification Name	Enteroscope And Accessories   More FDA Info for this Device
510(K) Number	K183032
Device Name	Enteroscope And Accessories
Applicant	FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-Gun 258-8538 JP Other 510(k) Applications for this Company
Contact	Randy Vader Vader 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	11/01/2018
Decision Date	06/24/2019
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