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510(k) Data Aggregation

    K Number
    K161421
    Device Name
    Single Use Surgical Suction Irrigator
    Manufacturer
    JIANGSU HAIZE MEDICAL SCIENTIFIC DEVELOPMENT CO.,LTD.
    Date Cleared
    2016-06-24

    (32 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    JIANGSU HAIZE MEDICAL SCIENTIFIC DEVELOPMENT CO.,LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Single Use Surgical Suction is indicated to provide suction and irrigation functions in general surgery and laparoscopic surgery to help remove dropsy, hematocele and tissue debris by vacuum aspiration and deliver irrigation fluids to surgical site.
    Device Description
    Single Use Surgical Suction Irrigator, models: JM-CX1A, JM-CX4, JM-CX4B
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