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510(k) Data Aggregation

    K Number
    K090078
    Device Name
    KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT
    Manufacturer
    IOP, INC.
    Date Cleared
    2009-05-08

    (116 days)

    Product Code
    NXM
    Regulation Number
    886.3130
    Why did this record match?
    Product Code :

    NXM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KaraSys Bioengineered Lamellar Patch Graft is intended for implantation to reinforce sclera and aid the physical reconstruction of the ocular surface. KaraSys is labeled for single use.
    Device Description
    The KeraSys Bioengineered Lamellar Patch Graft is constructed from four layers of laminated porcine small intestinal submucosa (SIS). The dchydrated device is supplied sterile sealed in a double peel pouch system. Unit size is 1x1.5cm
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    K Number
    K053622
    Device Name
    SURGISIS OCULAR GRAFT
    Manufacturer
    IOP, INC.
    Date Cleared
    2006-03-15

    (77 days)

    Product Code
    NXM
    Regulation Number
    886.3130
    Why did this record match?
    Product Code :

    NXM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SURGISIS Ocular Graft is intended for implantation to reinforce and support the reconstruction of the soft tissue of the eyelid. The SURGISIS Ocular Graft is intended for implantation to reinforce and aid reconstruction of the eyelid and is labeled for single use.
    Device Description
    The SURGISIS Ocular Graft is derived from porcine small intestinal submucosa (SIS). The material is prepared into sheets of various sizes and thicknesses appropriate for the reconstruction and repair of soft tissues. The device is supplied sterile in a dry lyophilized state sealed in a double peel pouch system
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