BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SERI SURGICAL SCAFFOLD

    K Number: K123128 · Decision Apr 25, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    7
    Applicant Total
    6
    Review Days
    203

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    Basic Information

    Device Name
    SERI SURGICAL SCAFFOLD
    K Number
    K123128
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Allergan
    Date Received
    October 4, 2012
    Decision Date
    April 25, 2013
    Product Code
    OXF
    Advisory Committee
    General, Plastic Surgery
    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
    OXF Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery

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