BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇮🇹 Italy

    SCULPTURE

    K Number: K971609 · Decision Aug 14, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    116
    Same Product Code
    156
    Applicant Total
    2
    Review Days
    105

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    Basic Information

    Device Name
    SCULPTURE
    K Number
    K971609
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Servizi Medico Estetici Italinai Srl.
    Date Received
    May 1, 1997
    Decision Date
    August 14, 1997
    Product Code
    LFL
    Advisory Committee
    Unknown
    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
    LFL Instrument, Ultrasonic Surgical

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    Other Clearances by Servizi Medico Estetici Italinai Srl.

    K Number Device Name
    K980301 IP-16