FUJINON COLONOSCOPES


Device Classification Name

colonoscope and accessories, flexible/rigid

510(k) Number K112391
Device Name FUJINON COLONOSCOPES
Applicant
FUJINON, INC.
10 high point dr.
wayne, 
NJ 
07470

Applicant Contact gina walljasper
Correspondent
FUJINON, INC.
10 high point dr.
wayne, 
NJ 
07470

Correspodent Contact gina walljasper
Regulation Number 876.1500
Classification Product Code
FDF  
Date Received 08/19/2011
Decision Date 07/26/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No