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

    STERILE DISP. BUTTERFLY INFUSION SET

    K Number: K832104 · Decision Sep 12, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    8
    Review Days
    81

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    Basic Information

    Device Name
    STERILE DISP. BUTTERFLY INFUSION SET
    K Number
    K832104
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Lee Medical Intl., Inc.
    Date Received
    June 23, 1983
    Decision Date
    September 12, 1983
    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 Lee Medical Intl., Inc.

    K Number Device Name
    K840081 IV ADMINISTRATION SET
    K840082 STERILE INSULIN DISPOS. NEEDLE/SYRINGE
    K840083 STERILE INSULIN DISPOS. NEEDLE/GREEN
    K832105 ADMINISTRATIVE IV SET
    K832101 STERILE DISPOSABLE SYRINGE
    K832102 STERILE DISPOSABLE NEEDLES
    K832103 BLOOD TUBING SET