XTJF TYPE Q160VF1


Device Classification Name

duodenoscope and accessories, flexible/rigid

510(k) Number K080403
Device Name XTJF TYPE Q160VF1
Applicant
OLYMPUS MEDICAL SYSTEMS CORPORATION
3500 corporate parkway
po box 610
center valley, 
PA 
18034 -0610

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

Correspodent Contact laura storm-tyler
Regulation Number 876.1500
Classification Product Code
FDT  
Date Received 02/14/2008
Decision Date 05/20/2008
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