BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS

    K Number: K130117 · Decision Oct 29, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    78
    Same Product Code
    46
    Applicant Total
    1
    Review Days
    286

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    Basic Information

    Device Name
    NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS
    K Number
    K130117
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4790
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Network Medical Products, Ltd.
    Date Received
    January 16, 2013
    Decision Date
    October 29, 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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