Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K172057 |
Device Name |
Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set |
Applicant |
Cook Ireland Ltd. |
O' Halloran Road, National Technology Park, |
Limerick,
IE
|
|
Applicant Contact |
Orla Gunning |
Correspondent |
Cook Ireland Ltd. |
O' Halloran Road, National Technology Park, |
Limerick,
IE
|
|
Correspondent Contact |
Orla Gunning |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 07/06/2017 |
Decision Date | 03/09/2018 |
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
|
|
|