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510(k) Data Aggregation

    K Number
    K023328
    Device Name
    REINFORCED ABSORBABLE SYNTHETIC SURGICAL MESH
    Date Cleared
    2002-12-12

    (69 days)

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

    CENTER FOR BIOMATERIALS AND ADVANCED TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Reinforced Absorbable Synthetic Surgical Mesh is indicated for use in the surgical repair of damaged or ruptured soft tissue where reinforcing or bridging materials are needed. This device is intended for one-time use.
    Device Description
    The reinforced absorbable synthetic surgical mesh is a foam encased mesh. The foam component is a biocompatible elastomeric polymer that is bioabsorbable. This elastomer exhibits a high percent elongation, while possessing good tensile strength and good recovery characteristics. It has been found to be non-antigenic, non-pyrogenic, and elicits a slight, but typical, tissue reaction during absorption. Therapeutically, the foam component provides wound support as well as increases the opportunity for bridging to occur due to its porosity. The mesh component is a woven polydioxanone mesh that is used to provide wound support during the healing process. It has been found to be non-antigenic, non-pyrogenic, and also elicits a slight, but typical, tissue reaction during absorption. Therapeutically, the mesh component retains strength for a period of time long enough to permit sufficient healing, preventing wound dehiscence.
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