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

    scaffolene CL100 Bioresorbable Collagen Matrix

    K Number: K192346 · Decision Feb 28, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    134
    Registration Numbers
    134
    Same Product Code
    187
    Applicant Total
    1
    Review Days
    183

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    Basic Information

    Device Name
    scaffolene CL100 Bioresorbable Collagen Matrix
    K Number
    K192346
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Freudenberg Technology Innovation SE & Co. KG
    Date Received
    August 29, 2019
    Decision Date
    February 28, 2020
    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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