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510(k) Data Aggregation

    K Number
    K031788
    Device Name
    PATHFINDER
    Date Cleared
    2004-09-02

    (450 days)

    Product Code
    Regulation Number
    886.1850
    Why did this record match?
    Applicant Name (Manufacturer) :

    MASSIE RESEARCH LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For general ophthalmic imaging, visualization, and fluorescein angiography including anterior and posterior segments of the eye.
    Device Description
    Not Found
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    K Number
    K001275
    Device Name
    RETCAM II
    Date Cleared
    2000-07-13

    (84 days)

    Product Code
    Regulation Number
    886.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    MASSIE RESEARCH LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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