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510(k) Data Aggregation

    K Number
    K033457
    Device Name
    M2 COMPATIBLE MICROKERATOME BLADE
    Date Cleared
    2004-05-25

    (208 days)

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

    MICRO SPECIALTIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Model 700700 M2 Compatible Microkeratome Blade is intended to be used as a replacement blade for the Moria M2 non-disposable Microkeratome K002191
    Device Description
    The MICROspecialties, Inc. disposable M2 compatible Microkeratome blade is a replacement stainless steel blade for the Moria M2 Microkeratome blade. Both blades are made of 400 series stainless steel and they are packaged and shipped using the same methods. Both blades are single-use, sterile, and disposable blades.
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