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

    MARLIN CONTACT LENS CASE

    K Number: K851497 · Decision May 16, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    73
    Applicant Total
    3
    Review Days
    31

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    Basic Information

    Device Name
    MARLIN CONTACT LENS CASE
    K Number
    K851497
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Marlin Industries
    Date Received
    April 15, 1985
    Decision Date
    May 16, 1985
    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 Marlin Industries

    K Number Device Name
    K850983 MARLIN SOFT LENS TWEEZER
    K850984 MARLIN SOFT LENS HANDLER