BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    CAPD PREP KIT

    K Number: K833780 · Decision Feb 9, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    104

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    Basic Information

    Device Name
    CAPD PREP KIT
    K Number
    K833780
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Professional Dialysis Products
    Date Received
    October 28, 1983
    Decision Date
    February 9, 1984
    Product Code
    FKG
    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
    FKG Tray, Start/Stop (Including Contents), Dialysis

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