BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇹 Italy

    LEM SUNGLASSES & FRAMES DIFF. COLORS AND DESIGNS

    K Number: K870219 · Decision Apr 16, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    1390
    Registration Numbers
    1390
    Same Product Code
    645
    Applicant Total
    2
    Review Days
    85

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    Basic Information

    Device Name
    LEM SUNGLASSES & FRAMES DIFF. COLORS AND DESIGNS
    K Number
    K870219
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.5850
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Lem Srl.
    Date Received
    January 21, 1987
    Decision Date
    April 16, 1987
    Product Code
    HQY
    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
    HQY Sunglasses (Non-Prescription Including Photosensitive)

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    K870220 LEM SPECTACLE FRAMES DIFFERENT COLORS AND DESIGNS