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

    POLARIS 100/200

    K Number: K123776 · Decision Mar 8, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    60
    Same Product Code
    28
    Applicant Total
    1
    Review Days
    88

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    Basic Information

    Device Name
    POLARIS 100/200
    K Number
    K123776
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Drager Medical GmbH
    Date Received
    December 10, 2012
    Decision Date
    March 8, 2013
    Product Code
    FTD
    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
    FTD Lamp, Surgical

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