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    K Number
    K172807
    Device Name
    Silicone Foley Catheter for single use
    Manufacturer
    Changzhou Rongxin Medicine Minimal Invasion Technology
    Date Cleared
    2018-06-04

    (259 days)

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

    Changzhou Rongxin Medicine Minimal Invasion Technology

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Two-way Disposable Silicone Foley Catheterization for bladder drainage and urological use only; the indwelling time is no more than 30 days. Three-way Disposable Silicone Foley Catheterization for bladder drainage and bladder irrigation for urological use only; the indwelling time is no more than 30 days.
    Device Description
    The Silicone Foley Catheter for single use is designed as an intermittent pathway for drainage and irrigation of the bladder. The device is made of silicone. The catheter is provided sterile in a variety of lengths and sizes.
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