HYDROGUM SOFT— 510(k) K043118
Substantially EquivalentZhermack S.P.A.
FDA 510(k) clearance K043118 for HYDROGUM SOFT, Substantially Equivalent on 2005-01-24. Applicant: Zhermack S.P.A.. Device class: 2.
Clearance details
- Applicant
- Zhermack S.P.A.
- Product code
- Product code ELW
- Device class
- Class 2
- Regulation
- 21 CFR 872.3660
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bend, OR, US
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