BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CENEFOM PVA SURGICAL SPEAR

    K Number: K082460 · Decision Dec 15, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    78
    Same Product Code
    46
    Applicant Total
    1
    Review Days
    111

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    Basic Information

    Device Name
    CENEFOM PVA SURGICAL SPEAR
    K Number
    K082460
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4790
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Longtek Scientific Co., Ltd.
    Date Received
    August 26, 2008
    Decision Date
    December 15, 2008
    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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