OLYMPUS XCHF TYPE B180Y1


Device Classification Name

choledochoscope and accessories, flexible/rigid

510(k) Number K080586
Device Name OLYMPUS XCHF TYPE B180Y1
Applicant
OLYMPUS MEDICAL SYSTEMS CORPORATION
3500 corporate parkway
po box 610
center valley, 
PA 
18034 -0610

Applicant Contact laura storms-tyler
Correspondent
OLYMPUS MEDICAL SYSTEMS CORPORATION
3500 corporate parkway
po box 610
center valley, 
PA 
18034 -0610

Correspodent Contact laura storms-tyler
Regulation Number 876.1500
Classification Product Code
FBN  
Date Received 03/03/2008
Decision Date 05/06/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No