Cook Ireland, Ltd. · Class II · Cleared Nov 2, 2009
| K-number | K092359 |
| Device name | ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A |
| Applicant | Cook Ireland, Ltd. |
| Product code | FCG |
| Device class | Class II |
| Decision date | Nov 2, 2009 |
| Decision | Substantially Equivalent |
| Regulation | 876.1075 |
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