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

    STERI-TRACT

    K Number: K811863 · Decision Sep 21, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    112
    Applicant Total
    1
    Review Days
    82

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    Basic Information

    Device Name
    STERI-TRACT
    K Number
    K811863
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Rogo Ent.
    Date Received
    July 1, 1981
    Decision Date
    September 21, 1981
    Product Code
    KDJ
    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
    KDJ Set, Administration, For Peritoneal Dialysis, Disposable

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