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510(k) Data Aggregation

    K Number
    K993190
    Device Name
    ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT SYSTEMS (SIS)
    Manufacturer
    SURGICAL INSTRUMENT SYSTEMS (SIS), LTD
    Date Cleared
    2000-02-10

    (140 days)

    Product Code
    HNO
    Regulation Number
    886.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    SURGICAL INSTRUMENT SYSTEMS (SIS), LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SIS, Ltd., ACCM microkeratome is a precision-manufactured instrument indicated for lamellar resection of the cornea.
    Device Description
    The SIS, Ltd ACCM Microkeratome is a precision-manufactured instrument designed for cutting a precise corneal disc of preselected thickness and diameter. The design, material and operating principle are very similar to those of the predicate devices.
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