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

    PRISM MEDICAL CUSTOM DIALYSIS KIT

    K Number: K941803 · Decision Jan 30, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    181
    Applicant Total
    1
    Review Days
    293

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    Basic Information

    Device Name
    PRISM MEDICAL CUSTOM DIALYSIS KIT
    K Number
    K941803
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Medical Device Support Services
    Date Received
    April 12, 1994
    Decision Date
    January 30, 1995
    Product Code
    KOC
    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
    KOC Accessories, Blood Circuit, Hemodialysis

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