BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MELANITE I

    K Number: K872506 · Decision Jul 27, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    638
    Registration Numbers
    640
    Same Product Code
    55
    Applicant Total
    2
    Review Days
    33

    Basic Information

    Device Name
    MELANITE I
    K Number
    K872506
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.5844
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    AURA LENS PRODUCTS
    Date Received
    June 24, 1987
    Decision Date
    July 27, 1987
    Product Code
    HQG
    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
    HQG Lens, Spectacle, Non-Custom (Prescription)

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