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510(k) Data Aggregation

    K Number
    K973103
    Device Name
    CHARTERMED TPN-EVA BAGS
    Manufacturer
    CHARTERMED, INC.
    Date Cleared
    1997-11-24

    (97 days)

    Product Code
    KPE
    Regulation Number
    880.5025
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHARTERMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Empty bags made from ethyl vinyl acetate (EVA) film intended to contain total parenteral nutrition (TPN) solutions and compatible medications.
    Device Description
    empty TPN bags made from EVA (ethylene vinyl acetate) plastic film in sizes ranging from 100mL to 3000mL in capacity
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