Alpha Pure— 510(k) K163117
Substantially EquivalentKoroad America
FDA 510(k) clearance K163117 for Alpha Pure, Substantially Equivalent on 2017-05-09. Applicant: Koroad America. Device class: 2.
Clearance details
- Applicant
- Koroad America
- Product code
- Code NJM
- Device class
- Class 2
- Regulation
- 21 CFR 872.5470
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newport Beach, CA, US
Recent devices under product code NJM
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