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    K Number
    K181750
    Device Name
    SITZMARKS
    Manufacturer
    Konsyl Pharmaceuticals
    Date Cleared
    2018-11-15

    (136 days)

    Product Code
    FFX
    Regulation Number
    876.1725
    Why did this record match?
    Applicant Name (Manufacturer) :

    Konsyl Pharmaceuticals

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SITZMARKS capsule is a diagnostic test inding in the evaluation of colonic motility in patients with severe constipation, as diagnosed by your healthcare professional, but otherwise negative GI evaluations. SITZMARKS capsule, for use in adult and pediatric patients (at least 2 years old), is to be dispensed only by physicians to patients for oral intake.
    Device Description
    Not Found
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