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

    BLOOD TUBING SET

    K Number: K832103 · Decision Aug 12, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    181
    Applicant Total
    8
    Review Days
    50

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    Basic Information

    Device Name
    BLOOD TUBING SET
    K Number
    K832103
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Lee Medical Intl., Inc.
    Date Received
    June 23, 1983
    Decision Date
    August 12, 1983
    Product Code
    KOC
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KOC Accessories, Blood Circuit, Hemodialysis

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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
    K832104 STERILE DISP. BUTTERFLY INFUSION SET
    K832101 STERILE DISPOSABLE SYRINGE
    K832102 STERILE DISPOSABLE NEEDLES