ENA CEM— 510(k) K062355
Substantially EquivalentMicerium S.P.A.
FDA 510(k) clearance K062355 for ENA CEM, Substantially Equivalent on 2006-12-27. Applicant: Micerium S.P.A.. Device class: 2.
Clearance details
- Applicant
- Micerium S.P.A.
- Product code
- Code EMA
- Device class
- Class 2
- Regulation
- 21 CFR 872.3275
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Avegno, Genoa, IT
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