BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    FLEXI-TY

    K Number: K832765 · Decision Jan 27, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    656
    Registration Numbers
    656
    Same Product Code
    99
    Applicant Total
    632
    Review Days
    164

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    Basic Information

    Device Name
    FLEXI-TY
    K Number
    K832765
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Bd Becton Dickinson Vacutainer Systems Preanalytic
    Date Received
    August 16, 1983
    Decision Date
    January 27, 1984
    Product Code
    GAD
    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
    GAD Retractor

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