BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇪 Ireland

    DUET

    K Number: K934970 · Decision Dec 10, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    53

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    Basic Information

    Device Name
    DUET
    K Number
    K934970
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.3750
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Trulife , Ltd.
    Date Received
    October 18, 1993
    Decision Date
    December 10, 1993
    Product Code
    GBJ
    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
    GBJ Prosthesis, Adhesive, External

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