The following data is part of a premarket notification filed by Cook Ireland Ltd with the FDA for Echotip Ultra Endobronchial High Definition Ultasound Needle, Model: Echo-hd-22-ebus-o.
| Device ID | K093195 |
| 510k Number | K093195 |
| Device Name: | ECHOTIP ULTRA ENDOBRONCHIAL HIGH DEFINITION ULTASOUND NEEDLE, MODEL: ECHO-HD-22-EBUS-O |
| Classification | Biopsy Needle |
| Applicant | COOK IRELAND LTD O'HALLORAN ROAD NATIONAL TECHNOLOGY PARK Limerick, IE |
| Contact | Jacinta Kilmartin |
| Correspondent | Jacinta Kilmartin COOK IRELAND LTD O'HALLORAN ROAD NATIONAL TECHNOLOGY PARK Limerick, IE |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-09 |
| Decision Date | 2010-01-21 |
| Summary: | summary |