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

    OPTIKEM PMMA CONTACT LENS

    K Number: K895411 · Decision Feb 27, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    73
    Applicant Total
    1
    Review Days
    174

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    Basic Information

    Device Name
    OPTIKEM PMMA CONTACT LENS
    K Number
    K895411
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Optikem Polymers, Inc.
    Date Received
    September 6, 1989
    Decision Date
    February 27, 1990
    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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