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510(k) Data Aggregation

    K Number
    K072334
    Device Name
    SIALO DRAIN
    Manufacturer
    SIALO TECHNOLOGY, LTD.
    Date Cleared
    2008-07-18

    (333 days)

    Product Code
    OAJ
    Regulation Number
    878.4200
    Why did this record match?
    Product Code :

    OAJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sialo Drain is a medical device for use by qualified surgeons in the treatment of salivary gland diseases for the purpose of drainage. The Sialo Drain is an intraoral/extraoral drainage catheter, intended to allow continuous drainage of saliva and/or fluid irrigation of the salivary duct by temporary insertion into the salivary gland, whether orally or through the cheek.
    Device Description
    The Sialo drain is a flexible, single lumen, sterile, single use, disposable cannula made of biocompatible radio-opaque polyurethane material.
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