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510(k) Data Aggregation

    K Number
    K052759
    Device Name
    DAN MONOPOLAR LAP ACCESSORIES
    Manufacturer
    DANNORITZER MEDIZINTECHNIK GMBH & CO. KG
    Date Cleared
    2006-06-14

    (257 days)

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

    **DANNORITZER MEDIZINTECHNIK GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DAN Monopolar Lap Accessories are reusable devices (forceps and electrodes) intended to be used in general laparoscopic surgical procedures requiring the use of electrosurgical cutting and/or coagulation.
    Device Description
    DAN Monopolar Lap Accessories consist of Standard insulated monopolar handles Insulated shafts Class I inserts (forceps, scissors, biopsy cups, needle holders) Electrodes The device is reusable and provided non-sterile. It must be cleaned and sterilized before use.
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