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

    ELCAM STOPCOCKS AND MANIFOLDS

    K Number: K022895 · Decision Oct 18, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    88
    Applicant Total
    14
    Review Days
    45

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    Basic Information

    Device Name
    ELCAM STOPCOCKS AND MANIFOLDS
    K Number
    K022895
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medical Device Consultants, Inc.
    Date Received
    September 3, 2002
    Decision Date
    October 18, 2002
    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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