BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇩🇪 Germany

    GLANDOSANE (SALIVART) SYNTHETIC SALIVA

    K Number: K874106 · Decision Apr 15, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    40
    Same Product Code
    49
    Applicant Total
    38
    Review Days
    189

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    Basic Information

    Device Name
    GLANDOSANE (SALIVART) SYNTHETIC SALIVA
    K Number
    K874106
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Fresenius USA, Inc.
    Date Received
    October 9, 1987
    Decision Date
    April 15, 1988
    Product Code
    LFD
    Advisory Committee
    Unknown
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LFD Saliva, Artificial

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