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    K Number
    K111681
    Device Name
    HISTOBRUSH
    Manufacturer
    PURITAN MEDICAL PRODUCTS COMPANY LLC
    Date Cleared
    2012-01-19

    (218 days)

    Product Code
    HHT
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    PURITAN MEDICAL PRODUCTS COMPANY LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To obtain endocervical cells for Pap smear cytology test
    Device Description
    The Puritan Histobrush consists of nylon bristles secured by stainless steel to a plastic handle. The device is used to obtain endocervical samples for Pap smear cytology. The device is for single use only and is non-sterile.
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