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

    THE ULTRA-MATE LENS

    K Number: K854218 · Decision Nov 12, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    602
    Registration Numbers
    602
    Same Product Code
    55
    Applicant Total
    2
    Review Days
    26

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    Basic Information

    Device Name
    THE ULTRA-MATE LENS
    K Number
    K854218
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.5844
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Optical Systems Intl., Inc.
    Date Received
    October 17, 1985
    Decision Date
    November 12, 1985
    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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