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

    NORMOCARD 25 (STERILE BICARBONATE RENAL DIALYSIS CONCENTRATE)

    K Number: K050827 · Decision Aug 22, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    122
    Applicant Total
    1
    Review Days
    143

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    Basic Information

    Device Name
    NORMOCARD 25 (STERILE BICARBONATE RENAL DIALYSIS CONCENTRATE)
    K Number
    K050827
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dialysis Solutions, Inc.
    Date Received
    April 1, 2005
    Decision Date
    August 22, 2005
    Product Code
    KPO
    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
    KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

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