BTM Wound Dressing— 510(k) K142879

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..

Clearance details

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

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