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

    BOSTON SCIENTIFIC SURGICAL MESH

    K Number: K081275 · Decision Aug 27, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    19
    Applicant Total
    432
    Review Days
    114

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    Basic Information

    Device Name
    BOSTON SCIENTIFIC SURGICAL MESH
    K Number
    K081275
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston Scientific Corp
    Date Received
    May 5, 2008
    Decision Date
    August 27, 2008
    Product Code
    PAH
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling

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