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510(k) Data Aggregation

    K Number
    K183316
    Device Name
    Dr J Spinal and Epidural Needles
    Manufacturer
    Dr. Japan Co., Ltd.
    Date Cleared
    2019-08-12

    (255 days)

    Product Code
    BSP
    Regulation Number
    868.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dr. Japan Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dr. J Spinal and Epidural Needles are intended to be used for injection of local anesthetics into a patient to provide regional anesthesia
    Device Description
    Dr. J Spinal and Epidural Needles are intended to be used for injection of local anesthetics into a patient to provide regional anesthesia. The Dr. J Spinal and Epidural Needles are supplied sterile, intended to be single use. Dr. J Spinal Needles are composed of a stainless-steel cannula, a hub, a stainless-steel stylet and plunger. A guide needle may be attached to this product. The spinal needle is supplied in either the Quincke Point (=K-3 Point) or the Pencil Point. The Dr. J Epidural Needle is composed of a stainless-steel cannula with depth marker, a hub, a stainlesssteel stylet, a plunger and a wing. The Dr J Epidural Needle is supplied in Detachable wing type which has a curved needle tip design to protect the catheter from damage during catheterization.
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