PuraStat-RM— 510(k) K261504
Substantially Equivalent3-D Matrix, Inc.
FDA 510(k) clearance K261504 for PuraStat-RM, Substantially Equivalent on 2026-08-03. Applicant: 3-D Matrix, Inc.. Device class: Unclassified.
Clearance details
- Applicant
- 3-D Matrix, Inc.
- Product code
- Code PHN
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newton, MA, US
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