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510(k) Data Aggregation

    K Number
    K082415
    Device Name
    PRODIGY NPWT SYSTEM MODEL PRODIGY 800V
    Manufacturer
    PREMCO MEDICAL SYSTEMS, INC.
    Date Cleared
    2008-11-25

    (96 days)

    Product Code
    OMP
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    PREMCO MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Prodigy™ 800V NPWT System is indicated for use in patients that would benefit from a suction device particularly as the device may promote wound healing or for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious material from a patients airway or respiratory support system either during surgery or at the patients bedside.
    Device Description
    Not Found
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