Device Classification Name |
stents, drains and dilators for the biliary ducts
|
510(k) Number |
K060624 |
Device Name |
MARATHON STENT WITH FUSION TECHNOLOGY |
Applicant |
COOK IRELAND LTD |
O'HOLLORAN ROAD |
NATIONAL TECHNOLOGICAL PARK |
LIMERICK,
IE
|
|
Applicant Contact |
EMMETT DEVEREUX |
Correspondent |
COOK IRELAND LTD |
O'HOLLORAN ROAD |
NATIONAL TECHNOLOGICAL PARK |
LIMERICK,
IE
|
|
Correspondent Contact |
EMMETT DEVEREUX |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 03/08/2006 |
Decision Date | 08/04/2006 |
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
|
|
|