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

    HESUNG'S BLOOD DONOR SETS

    K Number: K841561 · Decision Aug 30, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    29
    Applicant Total
    6
    Review Days
    48

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    Basic Information

    Device Name
    HESUNG'S BLOOD DONOR SETS
    K Number
    K841561
    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
    July 13, 1984
    Decision Date
    August 30, 1984
    Product Code
    BRZ
    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
    BRZ Set, Blood Transfusion

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    Other Clearances by Amkor Trading Co.

    K Number Device Name
    K841562 HESUNG BLOOD TRANSFUSION SETS
    K841565 HESUNG'S HYPERDERMIC NEEDLES
    K841564 HESUNG SCALP VEIN SET
    K841563 HESUNG'S SOLUTION INFUSION SETS
    K841566 HESUNG DISPOSABLE SYRINGE