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

    REFRACTIVE SURGERY BLADES

    K Number: K001806 · Decision Sep 12, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    82
    Applicant Total
    5
    Review Days
    89

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    Basic Information

    Device Name
    REFRACTIVE SURGERY BLADES
    K Number
    K001806
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4370
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Millennium Biomedical, Inc.
    Date Received
    June 15, 2000
    Decision Date
    September 12, 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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    Other Clearances by Millennium Biomedical, Inc.

    K Number Device Name
    K041110 MB 105 MILLENNIUM BLADES
    K020122 MB 102 MILLENNIUM BLADES
    K011833 MB 103 MILLENNIUM BLADES
    K003143 MILLENNIUM BLADES, MODEL MB101