ESTEYA— 510(k) K132092
Substantially EquivalentNucletron B.V.
FDA 510(k) clearance K132092 for ESTEYA, Substantially Equivalent on 2013-09-26. Applicant: Nucletron B.V.. Device class: 2.
Clearance details
- Applicant
- Nucletron B.V.
- Product code
- Code JAD
- Device class
- Class 2
- Regulation
- 21 CFR 892.5900
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rice Lake, WI, US
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