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510(k) Data Aggregation

    K Number
    K991548
    Device Name
    HAL SCOPE HOLDER SYSTEM
    Manufacturer
    NOVED MEDICAL
    Date Cleared
    1999-06-23

    (51 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOVED MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The HAL Scope Holder System is intended for use during medical procedure where sterile barrier is required on manipulating/ movable arms. It is for single use only.
    Device Description
    The HAL Scope Holder System is used to provide a sterile barrier for re-usable manipulating arm. The disposable cover includes a sterile quick release scope adapter and sterile drape assembly. The device will be installed to an existing re-usable manipulating arm before a medical procedure to act as a barrier between the sterile field and the non-sterile re-usable manipulating arm. The device is single use only and can be used with Noved Medical Universal Arm.
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