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510(k) Data Aggregation

    K Number
    K972781
    Device Name
    OT-1
    Manufacturer
    PRISM THERAPEUTICS, LLC.
    Date Cleared
    1997-09-19

    (56 days)

    Product Code
    FED
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRISM THERAPEUTICS, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To be used with an endoscope when repeated endoscopic intubation is anticipated; e.g. change of endoscopes or removal of multiple foreign bodies.
    Device Description
    OT-1 Endoscopic Overtube
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