BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇩🇪 Germany

    SupraSDRM Biodegradable Matrix Wound Dressing

    K Number: K170213 · Decision Jun 28, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    18
    Applicant Total
    2
    Review Days
    155

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    Basic Information

    Device Name
    SupraSDRM Biodegradable Matrix Wound Dressing
    K Number
    K170213
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Polymedics Innovations, GmbH
    Date Received
    January 24, 2017
    Decision Date
    June 28, 2017
    Product Code
    QSZ
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QSZ Absorbable Synthetic Wound Dressing

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    Other Clearances by Polymedics Innovations, GmbH

    K Number Device Name
    K090160 SUPRATHEL WOUND AND BURN DRESSING