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510(k) Data Aggregation

    K Number
    K961934
    Device Name
    PURITAN FOAM TIP SWAB MODEL 2197
    Manufacturer
    HARDWOOD PRODUCTS CO., LP
    Date Cleared
    1996-07-09

    (53 days)

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

    HARDWOOD PRODUCTS CO., LP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Puritan Foam Tip Swab is used to obtain a Pap smear sample from the endocervix.
    Device Description
    The Puritan Foam Tip Swab consists of a polyurethane foam tip bonded to a high impact polystyrene shaft with hot melt adhesive. The device is for single use only and non-sterile.
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