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

    UVASORB-400

    K Number: K854442 · Decision Feb 19, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    73
    Applicant Total
    2
    Review Days
    106

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    Basic Information

    Device Name
    UVASORB-400
    K Number
    K854442
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Optatint, Inc.
    Date Received
    November 5, 1985
    Decision Date
    February 19, 1986
    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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