COOK IRELAND ECHOBRUSH— 510(k) K052279
Substantially EquivalentCook Ireland, Ltd.
FDA 510(k) clearance K052279 for COOK IRELAND ECHOBRUSH, Substantially Equivalent on 2005-10-11. Applicant: Cook Ireland, Ltd.. Device class: 2.
Clearance details
- Applicant
- Cook Ireland, Ltd.
- Product code
- Code FDX
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Limerick, IE
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Data sourced from openFDA. This site is unofficial and independent of the FDA.