PreXion3D Excelsior— 510(k) K173878
Substantially EquivalentPrexion Corporation
FDA 510(k) clearance K173878 for PreXion3D Excelsior, Substantially Equivalent on 2018-01-19. Applicant: Prexion Corporation. Device class: 2.
Clearance details
- Applicant
- Prexion Corporation
- 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
- Special
- Location
- Chiyoda-Ku, JP
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