BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

    GORE BIO-A WOUND MATRIX

    K Number: K132397 · Decision May 7, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    18
    Applicant Total
    163
    Review Days
    279

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    Basic Information

    Device Name
    GORE BIO-A WOUND MATRIX
    K Number
    K132397
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    W. L. Gore & Associates, Inc.
    Date Received
    August 1, 2013
    Decision Date
    May 7, 2014
    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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