The following data is part of a premarket notification filed by Cook Ireland with the FDA for Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set.
| Device ID | K180868 |
| 510k Number | K180868 |
| Device Name: | Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | Cook Ireland O'Halloran Road National Technology Park Limerick, IE |
| Contact | Jacinta Kilmartin |
| Correspondent | Jacinta Kilmartin Cook Ireland O'Halloran Road National Technology 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 | 2018-04-03 |
| Decision Date | 2018-07-06 |
| Summary: | summary |