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

    BREAST BOLSTER

    K Number: K020624 · Decision Sep 12, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    175
    Applicant Total
    2
    Review Days
    198

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    Basic Information

    Device Name
    BREAST BOLSTER
    K Number
    K020624
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1710
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Beekley Corp.
    Date Received
    February 26, 2002
    Decision Date
    September 12, 2002
    Product Code
    IZH
    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
    IZH System, X-Ray, Mammographic

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