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

    CHURCHILL MEDICAL SYSTEMS STOPCOCK

    K Number: K012157 · Decision Sep 11, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    88
    Applicant Total
    12
    Review Days
    62

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    Basic Information

    Device Name
    CHURCHILL MEDICAL SYSTEMS STOPCOCK
    K Number
    K012157
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Churchill Medical Systems, Inc.
    Date Received
    July 11, 2001
    Decision Date
    September 11, 2001
    Product Code
    FMG
    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
    FMG Stopcock, I.V. Set

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