NovoSorb® MTX— 510(k) K242149

Substantially Equivalent

Polynovo Biomaterials Pty, Ltd.

FDA 510(k) clearance K242149 for NovoSorb® MTX, Substantially Equivalent on 2025-03-05. Applicant: Polynovo Biomaterials Pty, Ltd..

Clearance details

Applicant: Polynovo Biomaterials Pty, Ltd.
Product code: Code QSZ
Advisory panel: Unknown
Date received: 2024-07-23
Decision date: 2025-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melbourne, AU

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