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

    HARD CONTACT LENS CASE

    K Number: K831973 · Decision Oct 19, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    73
    Applicant Total
    2
    Review Days
    121

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    Basic Information

    Device Name
    HARD CONTACT LENS CASE
    K Number
    K831973
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Moonbeam International, Inc.
    Date Received
    June 20, 1983
    Decision Date
    October 19, 1983
    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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    Other Clearances by Moonbeam International, Inc.

    K Number Device Name
    K840115 SWISS OPTICAL PRODUCTS-CONTACT CASE