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510(k) Data Aggregation

    K Number
    K021443
    Device Name
    56 SERIES JET NEBULIZER
    Manufacturer
    PROJECT MARKETING
    Date Cleared
    2002-10-21

    (168 days)

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

    PROJECT MARKETING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 56 Series Jet Nebulizer is a pneumatic nebulizer, which nebulizes specific drugs for inhalation by a patient.
    Device Description
    The 56 Series Jet Nebulizer is a pneumatic nebulizer, which nebulizes specific drugs for inhalation by a patient.
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    K Number
    K980074
    Device Name
    56 SERIES AEROSOL GENERATOR
    Manufacturer
    PROJECT MARKETING
    Date Cleared
    1998-06-12

    (155 days)

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

    PROJECT MARKETING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 56 series Aerosol Generator is for the production of compressed air to operate a nebulizer for the production of medical aerosol for respiratory disorders. The 56 series Aerosol Generator requires a nebulizer and medication for operation. The use of the 56 series Aerosol Generator is for the sole purpose of compressed air production and requires the order of a physician for medical use.
    Device Description
    Not Found
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