The following data is part of a premarket notification filed by Cook Ireland Ltd with the FDA for Resonance Metallic Ureteral Stent.
| Device ID | K063742 |
| 510k Number | K063742 |
| Device Name: | RESONANCE METALLIC URETERAL STENT |
| Classification | Stent, Ureteral |
| Applicant | COOK IRELAND LTD O'HALLORAN ROAD NATIONAL TECHNOLOGY PARK Limerick, IE |
| Contact | Sinead Burke |
| Correspondent | Sinead Burke COOK IRELAND LTD O'HALLORAN ROAD NATIONAL TECHNOLOGY PARK Limerick, IE |
| Product Code | FAD |
| CFR Regulation Number | 876.4620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-18 |
| Decision Date | 2007-05-08 |
| Summary: | summary |