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

    I.V. SKY-HOOK

    K Number: K912010 · Decision Aug 19, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    278
    Registration Numbers
    278
    Same Product Code
    35
    Applicant Total
    1
    Review Days
    105

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    Basic Information

    Device Name
    I.V. SKY-HOOK
    K Number
    K912010
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6990
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Dina - Industria, Comercio E Exportacao , Ltd.
    Date Received
    May 6, 1991
    Decision Date
    August 19, 1991
    Product Code
    FOX
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FOX Stand, Infusion

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