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510(k) Data Aggregation

    K Number
    K020702
    Device Name
    O'REGAN DISPOSABLE ANOSCOPE
    Manufacturer
    CANADIAN THEATRE PRODUCTS LTD.
    Date Cleared
    2002-03-29

    (25 days)

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

    CANADIAN THEATRE PRODUCTS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The O'Regan Disposable Anoscope is intended for physician use to examine the anal sphincter and anus, and, using additional accessories, to perform various diagnostic and therapeutic procedures.
    Device Description
    Similar to device's marketed prior to or after May 28, 1976. The O'Regan Disposable Anoscope is identical to other legal marketed devices such as the Dispos-A-Scope in terms of material, disposability, non-powered, design, and usage. The O'Regan Disposable Anoscope is constructed from a Medical Grade-Atohass Medical SG& 101PH material, and is FDA certified. The O'Regan Disposable Anoscope is for single patient use only, thus disposable eliminating the risk of cross infection and nullifying the need for sterilization. The O'Regan Disposable Anoscope is non-powered. It does not conduct electricity and is nonthermogenic. The O'Regan Disposable Anoscope has a distal and proximal port enabling precise isolation and accuracy of tissue or pathology. The O'Regan Disposable Anoscope has an ergonomic handle facilitating accurate physician manipulation. The O'Regan Disposable Anoscope will not crack or craze during normal one time usage.
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