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

    DESARA BLUE OV, DESARA BLUE SS

    K Number: K140843 · Decision Jul 1, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    64
    Applicant Total
    2
    Review Days
    90

    Basic Information

    Device Name
    DESARA BLUE OV, DESARA BLUE SS
    K Number
    K140843
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CALDERA MEDICAL
    Date Received
    April 2, 2014
    Decision Date
    July 1, 2014
    Product Code
    OTN
    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
    OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

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