NovoSorb BTM— 510(k) K251567

Substantially Equivalent

Polynovo Biomaterials Pty, Ltd.

FDA 510(k) clearance K251567 for NovoSorb BTM, Substantially Equivalent on 2025-06-20. Applicant: Polynovo Biomaterials Pty, Ltd..

Clearance details

Applicant: Polynovo Biomaterials Pty, Ltd.
Product code: Code QSZ
Advisory panel: Unknown
Date received: 2025-05-22
Decision date: 2025-06-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Melbourne, AU

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Data sourced from openFDA. This site is unofficial and independent of the FDA.