BTM Wound Dressing— 510(k) K142879

Name: FDA 510(k) clearance K142879
Creator: U.S. Food and Drug Administration
Published: 2015-12-23

Substantially Equivalent

Polynovo Biomaterials Pty, Ltd.

FDA 510(k) clearance K142879 for BTM Wound Dressing, Substantially Equivalent on 2015-12-23. Applicant: Polynovo Biomaterials Pty, Ltd.. Device class: Unclassified.

Clearance details

Applicant: Polynovo Biomaterials Pty, Ltd.
Product code: Code QSZ
Device class: Unclassified
Advisory panel: Unknown
Date received: 2014-10-02
Decision date: 2015-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Melbourne, AU

Download summary PDF View on FDA.gov ↗

Recent devices under product code QSZ

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K254256 — LUOFUCON® Wound Matrix2026-08-18
K260020 — Redermo Wound Matrix2026-04-16
K251567 — NovoSorb BTM2025-06-20
K242149 — NovoSorb® MTX2025-03-05

More clearances from Polynovo Biomaterials Pty, Ltd.

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K221686 — NovoSorb Matrix2022-09-15
K172140 — NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm)2017-08-11
K132936 — NOVOPORE DRESSING2014-03-04

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