BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CoStorSol plus G

    K Number: K151728 · Decision Sep 18, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    42
    Applicant Total
    6
    Review Days
    84

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    Basic Information

    Device Name
    CoStorSol plus G
    K Number
    K151728
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5880
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Preservation Solutions, Inc.
    Date Received
    June 26, 2015
    Decision Date
    September 18, 2015
    Product Code
    KDN
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KDN System, Perfusion, Kidney

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    Other Clearances by Preservation Solutions, Inc.

    K Number Device Name
    K091245 COSTORSOL
    K083453 COSTORSOL
    K080432 MAPERSOL
    K073693 COSTORSOL
    K022826 CLEAR-IT ANTI-FOG, MODEL PS003