BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇳🇱 Netherlands

    AONGEN COLLAGEN MATRIX

    K Number: K080868 · Decision May 14, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    134
    Registration Numbers
    134
    Same Product Code
    187
    Applicant Total
    3
    Review Days
    412

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    Basic Information

    Device Name
    AONGEN COLLAGEN MATRIX
    K Number
    K080868
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aeon Astron Europe B.V.
    Date Received
    March 28, 2008
    Decision Date
    May 14, 2009
    Product Code
    KGN
    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
    KGN Wound Dressing With Animal-Derived Material(S)

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    Other Clearances by Aeon Astron Europe B.V.

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