The following data is part of a premarket notification filed by Cook Ireland Ltd with the FDA for Cook Ireland Sonnet Polypectomy Snare.
| Device ID | K050294 |
| 510k Number | K050294 |
| Device Name: | COOK IRELAND SONNET POLYPECTOMY SNARE |
| Classification | Snare, Flexible |
| 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 | FDI |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-07 |
| Decision Date | 2005-03-31 |
| Summary: | summary |