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

    TUBING, DIALYSATE (AND CONNECTOR)

    K Number: K022068 · Decision Sep 23, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    2
    Applicant Total
    7
    Review Days
    90

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    Basic Information

    Device Name
    TUBING, DIALYSATE (AND CONNECTOR)
    K Number
    K022068
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Molded Products, Inc.
    Date Received
    June 25, 2002
    Decision Date
    September 23, 2002
    Product Code
    FID
    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
    FID Tubing, Dialysate

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