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    K Number
    K031404
    Device Name
    DIGNITY OPHTHALMIC SURGICAL SYSTEM
    Manufacturer
    PHACOR INC., A SANTEN COMPANY
    Date Cleared
    2003-05-22

    (17 days)

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

    PHACOR INC., A SANTEN COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Dignity™ Ophthalmic Surgical System is a Phacofragmentation device intended for use in cataract surgery to emulsify, and extract the cataract.
    Device Description
    The Dignity™ Ophthalmic Surgical System is used by ophthalmic surgeons to perform cataract surgery. The system utilizes accessories connected to the console to perform the cataract surgery.
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