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

    STOPCOCKS & EXTENSION TUBES

    K Number: K840394 · Decision Mar 19, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    88
    Applicant Total
    64
    Review Days
    49

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    Basic Information

    Device Name
    STOPCOCKS & EXTENSION TUBES
    K Number
    K840394
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    American Pharmaseal Div. Ahsc
    Date Received
    January 30, 1984
    Decision Date
    March 19, 1984
    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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