GALILEOS FAMILY— 510(k) K123070
Substantially EquivalentSirona Dental Systems GmbH
FDA 510(k) clearance K123070 for GALILEOS FAMILY, Substantially Equivalent on 2013-03-15. Applicant: Sirona Dental Systems GmbH. Device class: 2.
Clearance details
- Applicant
- Sirona Dental Systems GmbH
- Product code
- Code OAS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bensheim, DE
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