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510(k) Data Aggregation

    K Number
    K983527
    Device Name
    MICROENDOSCOPE, MINIATURIZED BIOPSY SCOPE
    Manufacturer
    DOFI TECHNOLOGIES, INC.
    Date Cleared
    1999-01-19

    (103 days)

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

    DOFI TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Indications for this device use is for medical practitioner needing visualization of soft tissue, either through a natural orifice or incision. 'Use for visualization inside the human body to view surgical procedure(s), by physician. '
    Device Description
    The design of SOLOS ENDOSCOPY made/marketed endoscope K983538 is identical in every way as the scope approved for intended uses that are listed in this document. The physical characteristics, except for miniaturization, are identical as the approved device and this predicate device has been accepted with respect to: performance specifications, composition, intended use, technology employed, biocompatibility, manufacturing, QC, physical testing, etc.
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