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510(k) Data Aggregation

    K Number
    K081990
    Device Name
    LUBRICANO STERILE GEL
    Manufacturer
    FARCO PHARMA GMBH
    Date Cleared
    2008-12-05

    (144 days)

    Product Code
    FHX
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    FHX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sterile gel for human use, e.g. in medical procedures - to aid the introduction of catheters and endoscopic instruments in transurethral examinations, and in intermittent catheterization - particularly for incontinence treatment.
    Device Description
    Lubricano® Sterile Gel is a sterile, water-soluble gel composed of hydroxyethylcellulose, glycerol, and purified water, which is contained in a 10 mL syringe. Lubricano® Sterile Gel is free from fats, latex, disinfectants and preservatives. Lubricano® Sterile Gel ensures that catheters and instruments move easily, and it adheres well to the mucosa.
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