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510(k) Data Aggregation

    K Number
    K960811
    Device Name
    PHACOSCOPE
    Manufacturer
    SAINT JOHN'S PLAZA MEDICAL GROUP
    Date Cleared
    1996-10-02

    (218 days)

    Product Code
    HQC
    Regulation Number
    886.4670
    Why did this record match?
    Applicant Name (Manufacturer) :

    SAINT JOHN'S PLAZA MEDICAL GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Provide illumination at surgical site.
    Device Description
    Phacofragmentation system containing fiber optic light guides directed through fluid channels, and through infusion sleeve.
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