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510(k) Data Aggregation

    K Number
    K142076
    Device Name
    CLAVEGUARD FREEDOM SURGICAL LIGHT
    Manufacturer
    DICKSON & DICKSON HEALTHCARE (US), INC
    Date Cleared
    2014-09-30

    (61 days)

    Product Code
    FSY
    Regulation Number
    878.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    **DICKSON **& **DICKSON **HEALTHCARE (US), INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Claveguard Freedom Surgical Light is designed to illuminate the surgical site in Operating theatres
    Device Description
    The ClaveGuard Freedom surgical lights are suitable for all types of surgical procedures in operating rooms. The light is based on Light Emitting Diodes (LEDs) in combination with adaptive focus and shadow free illumination. It operates at a distance of 70-140cm from the surgical site. A light system may consist of 1 to 3 light heads supported by pivoting suspension system that is mounted to Healthcare facility's ceiling. The system may include optional monitor extension arms, monitor mounts, and in-light video camera.
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    K Number
    K091758
    Device Name
    BD SPINAL NEEDLE 27G
    Manufacturer
    BECTON DICKSON & CO.
    Date Cleared
    2009-10-09

    (115 days)

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

    BECTON **DICKSON **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.
    Device Description
    The BD Spinal needle consists of a non-lubricated stainless steel cannula attached to the needle hub using an insert molding process. When appropriate for the procedure, this needle includes a stylet. This stylet consists of nonlubricated stainless steel. The stainless steel stylet is attached to the stylet handle using an insert molding process. The needle assembly is protected with a polypropylene shield. The Spinal needle is packaged appropriately for either sterile or non-sterile, single use, purposes.
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