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510(k) Data Aggregation

    K Number
    K993463
    Device Name
    INTRAVASCULAR ADMINISTRATION SET
    Date Cleared
    2000-01-04

    (83 days)

    Product Code
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    CUSTOM ASSEMBLIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Indicated as a single use, sterile device for use in I.V. therapy when an extended fluid path is required for administration. Environment of use: Hospital, Emergency Medical Services, Home care settings wherever I.V. fluid administration may be indicated.
    Device Description
    The Custom Assemblies Extension Set is a tubing set with various connectors, and accessories, such as drip chambers, infusion line filters, clamps, integral check valves, spikes, Y-site injection sits used as an extension of a fluid pathway for I.V. administration.
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