SINGLE USE BILIARY DRAINAGE STENT V


Device Classification Name

catheter, biliary, diagnostic

510(k) Number K103478
Device Name SINGLE USE BILIARY DRAINAGE STENT V
Applicant
OLYMPUS MEDICAL SYSTEMS CORPORATION
3500 corporate parkway
po box 610
center valley, 
PA 
18034 -0610

Applicant Contact stacy abbatiello kluesner
Correspondent
OLYMPUS MEDICAL SYSTEMS CORPORATION
3500 corporate parkway
po box 610
center valley, 
PA 
18034 -0610

Correspodent Contact stacy abbatiello kluesner
Regulation Number 876.5010
Classification Product Code
FGE  
Date Received 11/26/2010
Decision Date 02/24/2011
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