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

    CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER

    K Number: K041038 · Decision Dec 21, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    86
    Registration Numbers
    86
    Same Product Code
    116
    Applicant Total
    12
    Review Days
    243

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    Basic Information

    Device Name
    CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER
    K Number
    K041038
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    880.5025
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Churchill Medical Systems, Inc.
    Date Received
    April 22, 2004
    Decision Date
    December 21, 2004
    Product Code
    KPE
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KPE Container, I.V.

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