EVOLUTION BILIARY STENT SYSTEM


Device Classification Name

catheter, biliary, diagnostic

510(k) Number K121430
Device Name EVOLUTION BILIARY STENT SYSTEM
Applicant
COOK IRELAND LTD
o halloran road
national technology park
limerick, 

IE

000

Applicant Contact jacinta kilmartin
Correspondent
COOK IRELAND LTD
o halloran road
national technology park
limerick, 

IE

000

Correspodent Contact jacinta kilmartin
Regulation Number 876.5010
Classification Product Code
FGE  
Date Received 05/14/2012
Decision Date 03/01/2013
Decision

se – with limitations

(SESU)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No