The following data is part of a premarket notification filed by Cook Ireland Ltd with the FDA for Evolution Colonic Stent System.
| Device ID | K113510 |
| 510k Number | K113510 |
| Device Name: | EVOLUTION COLONIC STENT SYSTEM |
| Classification | Stent, Colonic, Metallic, Expandable |
| Applicant | COOK IRELAND LTD O'HALLORAN ROAD NATIONAL TECHNOLOGY PARK Limerick, IE Ei |
| Contact | Jacinta Kilmartin |
| Correspondent | Jacinta Kilmartin COOK IRELAND LTD O'HALLORAN ROAD NATIONAL TECHNOLOGY PARK Limerick, IE Ei |
| Product Code | MQR |
| CFR Regulation Number | 878.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-28 |
| Decision Date | 2012-05-17 |
| Summary: | summary |