BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    Parietene DS Composite Mesh

    K Number: K163212 · Decision Jun 29, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    332
    Applicant Total
    10
    Review Days
    225

    Basic Information

    Device Name
    Parietene DS Composite Mesh
    K Number
    K163212
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sofradim Production
    Date Received
    November 16, 2016
    Decision Date
    June 29, 2017
    Product Code
    FTL
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FTL Mesh, Surgical, Polymeric

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    Other Clearances by Sofradim Production

    K Number Device Name
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    K223218 Parietene Macroporous Mesh
    K220586 Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh
    K192443 Dextile Anatomical Mesh
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