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

    MODIFICATION TO MALE TO MALE LUER ADAPTER

    K Number: K003712 · Decision May 16, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    181
    Applicant Total
    7
    Review Days
    166

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    Basic Information

    Device Name
    MODIFICATION TO MALE TO MALE LUER ADAPTER
    K Number
    K003712
    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
    December 1, 2000
    Decision Date
    May 16, 2001
    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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    Other Clearances by Molded Products, Inc.

    K Number Device Name
    K022068 TUBING, DIALYSATE (AND CONNECTOR)
    K010366 DISPOSABLE STORAGE CAP
    K010712 DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES
    K925978 MPC-80 TRANSDUCER
    K925930 MPC-150 MALE TO MALE LUER ADAPTER
    K925927 MPC-1000 INJECTION CAP/PLUG