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

    U-TOP ENTERPRISE CO SPECTACLE FRAMES & SUNGLASSES

    K Number: K942119 · Decision Jul 15, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    1549
    Registration Numbers
    1550
    Same Product Code
    645
    Applicant Total
    1
    Review Days
    73

    Basic Information

    Device Name
    U-TOP ENTERPRISE CO SPECTACLE FRAMES & SUNGLASSES
    K Number
    K942119
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.5850
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    U-TOP ENTERPRISE CO., LTD.
    Date Received
    May 3, 1994
    Decision Date
    July 15, 1994
    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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