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510(k) Data Aggregation

    K Number
    K993122
    Device Name
    MSP M/K BLADE
    Date Cleared
    2000-03-16

    (178 days)

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

    MEDICAL STERILE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MSP/MK Blade (#507-0028) is designed as a replacement blade for the Chiron Hansatome #507-0036-01 microkeratome for lamellar resection of the cornea.
    Device Description
    The microkeratome blades are manufactured either with a prefixed plastic post or have a slot/holes in the blade. The plastic post fits into a slot within the microkeratome instrument and the slot/holes in the blade are used to affix the blades to a stainless steel post on the microkeratome. The steel used for the blade in either configuration is the same, as well as the packaging and sterilization method. The blades are designed to be used in pre-existing, on the market, microkeratomes that presently use comparable disposable microkeratome blades. The microkeratome blades are single-use disposable. The blades are packaged in a plastic clamshell case and the case is packaged in a tyvek pouch. The blades are provided sterile.
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