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510(k) Data Aggregation
K Number
K201789Device Name
CT-STOR
Manufacturer
Energy Delivery Solutions
Date Cleared
2021-09-20
(447 days)
Product Code
NDS
Regulation Number
876.5885Why did this record match?
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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