BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DISPOSABLE H-PE MICROKERATOME BLADES

    K Number: K001464 · Decision Oct 2, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    82
    Applicant Total
    2
    Review Days
    145

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    Basic Information

    Device Name
    DISPOSABLE H-PE MICROKERATOME BLADES
    K Number
    K001464
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4370
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Oasis
    Date Received
    May 10, 2000
    Decision Date
    October 2, 2000
    Product Code
    HNO
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HNO Keratome, Ac-Powered

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