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

    PARCOMPLAST COMPENSATING FILTER FOR RADIATION THERAPY

    K Number: K021987 · Decision Dec 27, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    50
    Applicant Total
    2
    Review Days
    192

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    Basic Information

    Device Name
    PARCOMPLAST COMPENSATING FILTER FOR RADIATION THERAPY
    K Number
    K021987
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5710
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    S&S Par Scientific
    Date Received
    June 18, 2002
    Decision Date
    December 27, 2002
    Product Code
    IXI
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IXI Block, Beam-Shaping, Radiation Therapy

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