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510(k) Data Aggregation

    K Number
    K042666
    Device Name
    LUTH-ALL SUB-Q NEEDLE SET
    Date Cleared
    2004-12-21

    (83 days)

    Product Code
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUTH-ALL MEDICAL PRODUCTS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Luth-All Safety Sub-Q Needle Set is a device intended to administer drugs to a patient from a container by infusion subcutaneously. It operates as a standard safety needle with the addition of a built in active safety feature which when activated the device is designed to aid in reducing the possibility of accidental needle sticks.
    Device Description
    The Luth-All Safety Sub-Q Needle Set is a needle and administration set with a needlestick prevention feature, designed for use with a vascular access infusion system. It is manufactured with conventional medical grade, biocompatible materials. It operates as a standard safety needle with the addition of a built in active safety feature, which when activated the device is designed to aid in reducing the possibility of accidental needle sticks. It is supplied sterile for single use only.
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