Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
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
|
|
Correspondent Contact |
Jacinta Kilmartin |
Regulation Number | 876.5010
|
Classification Product Code |
|
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
|
|
|