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510(k) Data Aggregation

    K Number
    K042900
    Device Name
    K.E.P. CONNECTOR AND CLIP
    Manufacturer
    Date Cleared
    2004-11-05

    (17 days)

    Product Code
    Regulation Number
    876.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    K.E.P., LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The K.E.P. Connector and Clip is intended to secure the position of the outlet tubing of single-use peritoneal dialysis sets on any solid surface.
    Device Description
    The K.E.P. Connector and Clip comprises three major components: (1) the rightangle barbed tubing connector (outlet), (2) the wire frame, and (3) the suction cup. This device is provided to the user as an assembled device. The K.E.P Connector and Clip enables free flow of waste dialysate in a safe and hygienic manner. The suction cup is designed to adhere to ceramic or any other non-porous surface, unless intentionally released by the "A tab." The K.E.P. Connector and Clip has been designed with an air gap between the distal end of the connector and the discharge site (drain), thereby making it impossible for any fluid to back flow or to be restricted; this air gap is consistent with ASME designs for plumbing fixtures.
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