PuraStat-RM— 510(k) K261504

Substantially Equivalent

3-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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