PuraStat— 510(k) K253923
Substantially Equivalent3-D Matrix Europe SAS
FDA 510(k) clearance K253923 for PuraStat, Substantially Equivalent on 2026-01-07. Applicant: 3-D Matrix Europe SAS. Device class: Unclassified.
Clearance details
- Applicant
- 3-D Matrix Europe SAS
- Product code
- Code PHN
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Caluire Et Cuire, FR
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