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

    SULCUS BLUE

    K Number: K111978 · Decision Oct 13, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    35
    Applicant Total
    2
    Review Days
    93

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    Basic Information

    Device Name
    SULCUS BLUE
    K Number
    K111978
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Produits Dentaires Pierre Rolland
    Date Received
    July 12, 2011
    Decision Date
    October 13, 2011
    Product Code
    MVL
    Advisory Committee
    Unknown
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MVL Cord, Retraction

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    Other Clearances by Produits Dentaires Pierre Rolland

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