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)— 510(k) K172140

Name: FDA 510(k) clearance K172140
Creator: U.S. Food and Drug Administration
Published: 2017-08-11

Substantially Equivalent

Polynovo Biomaterials Pty, Ltd.

FDA 510(k) clearance K172140 for 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), Substantially Equivalent on 2017-08-11. 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: 2017-07-17
Decision date: 2017-08-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Port Melbourne, AU

Download summary PDF View on FDA.gov ↗

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