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510(k) Data Aggregation

    K Number
    K993651
    Device Name
    O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER
    Manufacturer
    SC HENNIG ENTERPRISES EUROPE SRL
    Date Cleared
    1999-12-23

    (55 days)

    Product Code
    GBM
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    SC HENNIG ENTERPRISES EUROPE SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The O'Neil Sterile Field Intermittent Urinary Catheter is a pre-lubricated urinary catheter with a specially designed silicone tip which is used to facilitate the urethral introduction of the catheter.
    Device Description
    The O'Neil Sterile Field Intermittent Urinary Catheter is a pre-lubricated urinary catheter with a specially designed silicone tip.
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