DENTRIa series— 510(k) K160140
Substantially EquivalentHdx Will Corp.
FDA 510(k) clearance K160140 for DENTRIa series, Substantially Equivalent on 2016-09-30. Applicant: Hdx Will Corp.. Device class: 2.
Clearance details
- Applicant
- Hdx Will Corp.
- 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
- Cheongju-Si, KR
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