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

    HESUNG BLOOD TRANSFUSION SETS

    K Number: K841562 · Decision Jul 23, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    6
    Review Days
    97

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    Basic Information

    Device Name
    HESUNG BLOOD TRANSFUSION SETS
    K Number
    K841562
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Amkor Trading Co.
    Date Received
    April 17, 1984
    Decision Date
    July 23, 1984
    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 Amkor Trading Co.

    K Number Device Name
    K841561 HESUNG'S BLOOD DONOR SETS
    K841565 HESUNG'S HYPERDERMIC NEEDLES
    K841564 HESUNG SCALP VEIN SET
    K841563 HESUNG'S SOLUTION INFUSION SETS
    K841566 HESUNG DISPOSABLE SYRINGE