BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇹 Italy

    SAFTE ORIONE HERNIA BELT ITEMS NO. 316, 515, 536

    K Number: K901922 · Decision Oct 26, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    179

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    Basic Information

    Device Name
    SAFTE ORIONE HERNIA BELT ITEMS NO. 316, 515, 536
    K Number
    K901922
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5970
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Safte S.P.A.
    Date Received
    April 30, 1990
    Decision Date
    October 26, 1990
    Product Code
    EXN
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EXN Support, Hernia