BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    SUNTOUCH EYE SPEAR

    K Number: K132796 · Decision Oct 30, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    78
    Same Product Code
    46
    Applicant Total
    22
    Review Days
    54

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    Basic Information

    Device Name
    SUNTOUCH EYE SPEAR
    K Number
    K132796
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4790
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Huizhou Foryou Medical Devices Co., Ltd.
    Date Received
    September 6, 2013
    Decision Date
    October 30, 2013
    Product Code
    HOZ
    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
    HOZ Sponge, Ophthalmic

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