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510(k) Data Aggregation

    K Number
    K110900
    Device Name
    DISPOSABLE THYROID COLLAR
    Manufacturer
    BLOXR CORPORATION
    Date Cleared
    2011-06-24

    (85 days)

    Product Code
    KPY
    Regulation Number
    892.6500
    Why did this record match?
    Product Code :

    KPY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Thyroid Collar is intended for use as a radiation shield against scatter radiation. It is intended to be placed around the neck of the user who remains outside of the primary radiation beam.
    Device Description
    The Disposable Thyroid Collar is a radiation protective shield for the thyroid intended to be used in various medical procedures where X-ray radiation is used. It is a non-sterile device, designed for single use. The device is constructed with environmentally friendly radiation attenuating materials, which do not contain lead or heavy metals. The radiation attenuating material is encased in a medical grade polypropylene (PP) non-woven drape material. The device is available in three sizes, small, medium, and large. The device blocks radiation in a similar manner to lead - via absorption of the photon energy from ionizing radiation. This photon energy is dissipated as phonon energy within the atomic lattice structure of the radiation attenuating material, in a manner identical to lead.
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    K Number
    K962622
    Device Name
    INTRA-ORAL THERMOPLASTIC SHIELD
    Manufacturer
    MEDTEC, INC.
    Date Cleared
    1996-10-01

    (88 days)

    Product Code
    KPY
    Regulation Number
    892.6500
    Why did this record match?
    Product Code :

    KPY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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