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

    STERILE INSULIN DISPOS. NEEDLE/GREEN

    K Number: K840083 · Decision Feb 21, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    8
    Review Days
    42

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    Basic Information

    Device Name
    STERILE INSULIN DISPOS. NEEDLE/GREEN
    K Number
    K840083
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Lee Medical Intl., Inc.
    Date Received
    January 10, 1984
    Decision Date
    February 21, 1984
    Product Code
    FMF
    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
    FMF Syringe, Piston

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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
    K832105 ADMINISTRATIVE IV SET
    K832104 STERILE DISP. BUTTERFLY INFUSION SET
    K832101 STERILE DISPOSABLE SYRINGE
    K832102 STERILE DISPOSABLE NEEDLES
    K832103 BLOOD TUBING SET