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510(k) Data Aggregation

    K Number
    K964779
    Device Name
    MODEL I 100 RF PASSIVE ATTENUATOR/SPLITTER AND MODEL QL 10 LOOP ELECTRODE
    Manufacturer
    QUANTUM LOOP, INC.
    Date Cleared
    1997-08-27

    (273 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUANTUM LOOP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The RF Passive Attenuator/Splitter Model I 100 I 200 and Cutting/Coagulating Electrode Model R 10 is indicated for the cutting and coagulation of the tissue. This device is intended for use by qualified medical personnel in the use of electrosurgery.
    Device Description
    RF Passive Attenuator/Splitter Model I 100, I 200 and Cutting/Coagulating Electrode Model R 10.
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