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510(k) Data Aggregation

    K Number
    K984600
    Device Name
    METRA PS PROCEDURE KIT
    Manufacturer
    INLET MEDICAL, INC.
    Date Cleared
    1999-06-03

    (157 days)

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

    INLET MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This procedure kit is intended to facilitate passage of suture through the soft tissues of the body during laparoscopic surgery. It is to be used only by surgeons trained in laparoscopic surgery.
    Device Description
    The components of the Mctra PS Procedure Kit are One needle point suture passer, one grasper, one knot pusher/ positioning device, suture matcrial, and two suture guides.
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