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510(k) Data Aggregation

    K Number
    K170134
    Device Name
    Reperen Surgical Mesh
    Manufacturer
    Date Cleared
    2017-08-09

    (204 days)

    Product Code
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    IconLab Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Reperen® Surgical Mesh is indicated for use in the reconstruction of hernias, soft tissue deficiencies and temporary bridging of fascial defects. It is not intended to be used for the reconstruction of cardiovascular defects.
    Device Description
    The Reperen® Surgical Mesh is made from a biocompatible, hydrophobic acrylic polymer. The implant has two distinct layers: 1st layer is a smooth transparent film of spatially cross-linked acrylic polymer with polyamide mesh embedded inside. The 2nd layer is a mesh of spatially cross-linked acrylic polymer, interconnected forming the rough surface. The thickness of the reinforcing layer (in the total thickness of the Reperen® Surgical Mesh) is 0.1 + 0.05 mm. The roughness of the parietal layer for Reperen® Surgical Mesh (all sizes) is about 100 um. The Reperen® Surgical Mesh is available in six different sizes as described in the table below. | | Designation | Shape | Size in mm | Thickness in mm, | Weight in gm | |----|---------------------|-------|------------|------------------|--------------| | | | | $\pm 3$ mm | $\pm 0.15$ mm | $\pm 20%$ | | 1. | Reperen®-15-150-100 | | 150 x 100 | 0.4 | 5.4 | | 2. | Reperen®-15-200-150 | oval | 200 x 150 | 0.4 | 10.8 | | 3. | Reperen®-15-250-150 | | 250 x 150 | 0.4 | 13.5 | | 4. | Reperen®-15-250-200 | | 250 x 200 | 0.4 | 18.0 | | 5. | Reperen®-15-300-200 | | 300 x 200 | 0.4 | 21.6 | | 6. | Reperen®-15-370-280 | | 370 x 280 | 0.4 | 37.2 |
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