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510(k) Data Aggregation

    K Number
    K052642
    Device Name
    SUTURING WASHER
    Manufacturer
    FIRST CALL, INC.
    Date Cleared
    2006-01-17

    (113 days)

    Product Code
    MAB
    Regulation Number
    870.3450
    Why did this record match?
    Applicant Name (Manufacturer) :

    FIRST CALL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This single use device is for radiological identification of the aortic anastomosis in coronary artery bypass surgery
    Device Description
    This 4.5mm outer diameter suturing washer is manufactured from either stainless steel (ASTM F-138) or titanium (ASTM F-136). It is permanently implanted and must be sterilized prior to use.
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