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510(k) Data Aggregation

    K Number
    K971887
    Device Name
    BREATH TAKER
    Manufacturer
    HOFA LLC.
    Date Cleared
    1997-06-10

    (20 days)

    Product Code
    LCN
    Regulation Number
    872.6855
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOFA LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Breath Taker is intended to be used for the manual removal of bacteria from the human tongue for the purpose of freshening the breath, enhancing taste and improving oral hygiene. It is used by placing the selected scraping edge on the back of the extended tongue then pulling forward with sufficient pressure to scrape the tongue and remove bacteria. The Breath Taker is intended for over-the-counter use as a personal hygiene tool by men and women of all ages and physical conditions.
    Device Description
    The Breath Taker is intended to be used for the manual removal of bacteria from the human tongue for the purpose of freshening the breath, enhancing taste and improving oral hygiene. It is used by placing the selected scraping edge on the back of the extended tongue then pulling forward with sufficient pressure to scrape the tongue and remove bacteria.
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