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

    DISPOSABLE STORAGE CAP

    K Number: K010366 · Decision Nov 28, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    130
    Applicant Total
    7
    Review Days
    294

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    Basic Information

    Device Name
    DISPOSABLE STORAGE CAP
    K Number
    K010366
    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
    February 7, 2001
    Decision Date
    November 28, 2001
    Product Code
    FJI
    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
    FJI Dialyzer, Capillary, Hollow Fiber

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    Other Clearances by Molded Products, Inc.

    K Number Device Name
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    K010712 DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES
    K003712 MODIFICATION TO MALE TO MALE LUER ADAPTER
    K925978 MPC-80 TRANSDUCER
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    K925927 MPC-1000 INJECTION CAP/PLUG