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510(k) Data Aggregation

    K Number
    K001594
    Device Name
    3.5 MM LAPAROSCOPE (LG100, LG103)
    Manufacturer
    SURGICAL IMAGE LABORATORIES, INC.
    Date Cleared
    2000-06-12

    (20 days)

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

    SURGICAL IMAGE LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K955845
    Device Name
    LL 100, 103, 104 DIAGNOSTIC LAPAROSCOPE RIGID ROD LENS
    Manufacturer
    SURGICAL IMAGE LABORATORIES, INC.
    Date Cleared
    1996-07-05

    (196 days)

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

    SURGICAL IMAGE LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    The Surgical Image Laboratories Laparoscope is equivalent in materials, intended use, safety and effectiveness to the Dyonics 8000 Laparoscope. The outer tube is fabricated from 304 stainless steel. The block and light adapter are made from plated brass and the I.D. ring from anodized aluminum. The distal end tip is fabricated from optical glass which may be coated with an anti-reflective coating. The optic tube which fits within the outer tube is fabricated from stainless steel. The distal fiber which transmits light from the light source through the fiber cone, around the optic tube, and on to the surgical area is fabricated from optical fibers and sealed at the distal end with adhesive. The eye shield or camera connection adapter is made from acetal plastic or an FDA accepted equivalent. All surfaces are smooth and polished or bead blasted. The end of the instrument that is inserted into the human body through an incision is blunt or rounded with no sharp edges.
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