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

    UNIVERSAL DISPOSABLE INFUSION SET (CODE 0205F)

    K Number: K861518 · Decision May 27, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    7
    Review Days
    34

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    Basic Information

    Device Name
    UNIVERSAL DISPOSABLE INFUSION SET (CODE 0205F)
    K Number
    K861518
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Jufrey Multimed Corp.
    Date Received
    April 23, 1986
    Decision Date
    May 27, 1986
    Product Code
    FPA
    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
    FPA Set, Administration, Intravascular

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    Other Clearances by Jufrey Multimed Corp.

    K Number Device Name
    K861519 UNIVERSAL DISPOSABLE INFUSION SET (CODE 0330F)
    K861521 UNIVERSAL DISPOSABLE INFUSION SET (CODE 0330)
    K861520 UNIVERSAL DISPOSABLE INFUSION SET (CODE 0205)
    K861523 STANDARD BLOOD TRANSFUSION FILTER SET (CODE 1025)
    K853527 JUFREY CORP. UNIV. DISPOS. SCALP VEIN INFUSION SET
    K853327 JUFREY CORP. UNIVERSAL DISPOS. SCALP VEIN INFUSION