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

    GLISLENS

    K Number: K823528 · Decision Dec 22, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    73
    Applicant Total
    1
    Review Days
    22

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    Basic Information

    Device Name
    GLISLENS
    K Number
    K823528
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Bio-Products, Inc.
    Date Received
    November 30, 1982
    Decision Date
    December 22, 1982
    Product Code
    HPX
    Advisory Committee
    Unknown
    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
    HPX Lens, Contact (Polymethylmethacrylate)

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