BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇹🇼 Taiwan

    MAGNIFYING SPECTACLES W/PLASTIC LENSES

    K Number: K844716 · Decision Jan 3, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    664
    Registration Numbers
    664
    Same Product Code
    10
    Applicant Total
    2
    Review Days
    30

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    Basic Information

    Device Name
    MAGNIFYING SPECTACLES W/PLASTIC LENSES
    K Number
    K844716
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.5840
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Gazelle Corp.
    Date Received
    December 4, 1984
    Decision Date
    January 3, 1985
    Product Code
    HOI
    Advisory Committee
    Ophthalmic
    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
    HOI Spectacle, Magnifying

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