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    K Number
    K100803
    Device Name
    OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1
    Manufacturer
    KEYMED, INC.
    Date Cleared
    2010-04-22

    (31 days)

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

    KEYMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Olympus Flushing Pump OFP is indicated for use during GI endoscopy, when blood, faeces or other organic matter obscure the endoscopic view, to wash the site being visualized.
    Device Description
    The Olympus Flushing Pump is peristaltic pump which facilitates direct washing of debris from the observation site during endoscopic examinations. The peristaltic pump and associated tubing allow irrigation water to be controlled and directed to the observation site to remove blood, faeces or other organic matter that may be obstructing the endoscopic view.
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