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510(k) Data Aggregation

    K Number
    K964920
    Device Name
    RPI DUAL PORT IRRIGATION ADAPTER
    Date Cleared
    1997-07-09

    (212 days)

    Product Code
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    RIDGE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The use of this device is to gain additional access to an Enteral Gastrostomy Tube or Nasogastric Tube for the purpose of irrigation or the administration of medications without having to disconnect the Enteral Feeding Administration Set from the patients feeding tube. The consistent connection or reconnection to a feeding tube each time a patient must be medicated or irrigated can not only cause patient discomfort, but also can cause the feeding tube to leak at the connection due to wear.
    Device Description
    RPI DUAL PORT IRRIGATION ADAPTER
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