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510(k) Data Aggregation

    K Number
    K201789
    Device Name
    CT-STOR
    Manufacturer
    Energy Delivery Solutions
    Date Cleared
    2021-09-20

    (447 days)

    Product Code
    NDS
    Regulation Number
    876.5885
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    Applicant Name (Manufacturer) :

    Energy Delivery Solutions

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CT-STOR is a liquid culture media intended for ex vivo cell and tissue processing applications
    Device Description
    CT-STOR is a tissue culture media intended for human ex vivo tissue and cell culture processing applications. AIM-V® is the predicate device and is also a tissue culture media intended for human ex vivo tissue and cell culture processing applications. CT-STOR and AIM-V® are composed of chemically defined nutrient materials in solution (with or without supplements) that are essential for the survival and development of tissue or cells of human or other animal origin. These nutrients are provided in liquid form for use in supporting the growth or maintenance of human tissue and cells.
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