EVOLUTION ESOPHAGEAL STENT SYSTEM


Device Classification Name

prosthesis, esophageal

510(k) Number K080359
Device Name EVOLUTION ESOPHAGEAL STENT SYSTEM
Applicant
COOK IRELAND LTD
o’halloran road
national technology park
limerick, 

IE

Applicant Contact noreen barry
Correspondent
COOK IRELAND LTD
o’halloran road
national technology park
limerick, 

IE

Correspodent Contact noreen barry
Regulation Number 878.3610
Classification Product Code
ESW  
Date Received 02/11/2008
Decision Date 05/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No