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    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    DynaMesh-POSTERIOR

    K Number: K182087 · Decision Oct 31, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    139
    Registration Numbers
    139
    Same Product Code
    335
    Applicant Total
    2
    Review Days
    90

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    Basic Information

    Device Name
    DynaMesh-POSTERIOR
    K Number
    K182087
    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
    Feg Textiltechnik Forschungs- Und Entwicklungsgesellschaft
    Date Received
    August 2, 2018
    Decision Date
    October 31, 2018
    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 Feg Textiltechnik Forschungs- Und Entwicklungsgesellschaft

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