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510(k) Data Aggregation

    K Number
    K042758
    Device Name
    POLYTECH PULMONARY FUNCTION FILTER
    Manufacturer
    POLYTECHNIC RESOURCES, INC.
    Date Cleared
    2005-08-29

    (329 days)

    Product Code
    BZG
    Regulation Number
    868.1840
    Why did this record match?
    Applicant Name (Manufacturer) :

    POLYTECHNIC RESOURCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Polytech filter is a disposable, single-patient session filter for spirometric and pulmonary function testing. The Polytech filter is designed to reduce cross contamination in pulmonary function equipment. The filter is to be used with children and adult subjects, but it is not indicated for use with neonatal subjects. It is to be used under the direction of a physician.
    Device Description
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