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

    VILET VILET QUICK

    K Number: K120556 · Decision May 23, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    147
    Applicant Total
    27
    Review Days
    89

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    Basic Information

    Device Name
    VILET VILET QUICK
    K Number
    K120556
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    878.4493
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Riverpoint Medical
    Date Received
    February 24, 2012
    Decision Date
    May 23, 2012
    Product Code
    GAM
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

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