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510(k) Data Aggregation

    K Number
    K991229
    Device Name
    K-SYSTEMS WORK STATIONS, TYPE L-13W, L-13E, L-13ES, L-13ET, L-13EM, L-23, L-23E, L-24, L-24E, L-25, L-25E, L-26, L-26E,L
    Manufacturer
    HENNING KNUDSEN ENGINEERING A/S
    Date Cleared
    1999-06-29

    (78 days)

    Product Code
    MQG
    Regulation Number
    884.6120
    Why did this record match?
    Applicant Name (Manufacturer) :

    HENNING KNUDSEN ENGINEERING A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The K-SYSTEMS Work Station is intended for maintaining temperature of gametes and/or embryos at or near body temperature. The work station also includes features to humidify and maintain a constant pH environment for the gametes and/or embryos. Additionally the work station is flushed with steribenair.
    Device Description
    Not Found
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