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    FDA 510(k), K142900, Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating Mesh

    FDA 510(k), K142900, Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating Mesh

    $170.23 USD
    $170.23 USD
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    510(K) Number: K142900
    Device Name: Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating Mesh
    Manufacturer: Eric Jague
    Device Classification Name: Mesh, Surgical, Polymeric
    Regulation Number: FTL
    Classification Product Code: KXA
    Date Received: 10/06/2014
    Decision Date: 10/28/2014
    Decision: Substantially Equivalent (SESE)
    Regulation Medical Specialty: General & Plastic Surgery

    Total pages: 144  
    Fully redacted pages: 89  
    Content pages: 55  

    PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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