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510(k) Data Aggregation

    K Number
    K993558
    Device Name
    EZFLOW MAX, MODEL 1007
    Date Cleared
    1999-11-12

    (23 days)

    Product Code
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    PIPER MEDICAL PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To be used to convert liquid medication into aerosol for inhalation by patient.
    Device Description
    Not Found
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    K Number
    K990384
    Device Name
    EZFLOW CONTINUOUS NEBULIZER,MODEL 1005
    Date Cleared
    1999-04-26

    (77 days)

    Product Code
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    PIPER MEDICAL PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To be used under proper medical supervision to deliver medicinal aerosol and diagnostic formulation.
    Device Description
    EZflow Continuous Nebulizer™ Model 1005
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    K Number
    K982408
    Device Name
    AEROTEE, MODEL # 1001
    Date Cleared
    1998-09-14

    (66 days)

    Product Code
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    PIPER MEDICAL PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For use with pneumatic small volume nebulizers to deliver aerosolized medication.
    Device Description
    Not Found
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