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

    DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES

    K Number: K010712 · Decision Sep 27, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    2
    Applicant Total
    7
    Review Days
    202

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    Basic Information

    Device Name
    DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES
    K Number
    K010712
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Molded Products, Inc.
    Date Received
    March 9, 2001
    Decision Date
    September 27, 2001
    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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