The following data is part of a premarket notification filed by Cook Ireland Ltd with the FDA for Marathon Stent With Fusion Technology.
| Device ID | K060624 |
| 510k Number | K060624 |
| Device Name: | MARATHON STENT WITH FUSION TECHNOLOGY |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | COOK IRELAND LTD O'HOLLORAN ROAD NATIONAL TECHNOLOGICAL PARK Limerick, IE |
| Contact | Emmett Devereux |
| Correspondent | Emmett Devereux COOK IRELAND LTD O'HOLLORAN ROAD NATIONAL TECHNOLOGICAL PARK Limerick, IE |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-08 |
| Decision Date | 2006-08-04 |
| Summary: | summary |