Encore System— 510(k) K201238
Substantially EquivalentSiesta Medical, Inc.
FDA 510(k) clearance K201238 for Encore System, Substantially Equivalent on 2020-10-02. Applicant: Siesta Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Siesta Medical, Inc.
- Product code
- Code ORY
- Device class
- Class 2
- Regulation
- 21 CFR 872.5570
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Los Gatos, CA, US
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