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510(k) Data Aggregation

    K Number
    K991958
    Device Name
    KLOUT SHAMPOO AND LICE COMBING PRETREATMENT KIT
    Manufacturer
    KIEL LABORATORIES, INC.
    Date Cleared
    1999-08-13

    (64 days)

    Product Code
    LJL
    Regulation Number
    880.5960
    Why did this record match?
    Applicant Name (Manufacturer) :

    KIEL LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    the removal of head lice and their eggs (nits) from hair
    Device Description
    The kit consists of two components, the combing pretreatment shampoo. The comb is stainless steel with the teeth set to 0.3 mm (300 micron) spacing and capable of removing nits which are greater than 0.3 mm when attached to the hair. The second element is a shampoo that contains no pesticides but does facilitate lice removal and allows for rinsing and combing the nits out of the hair.
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