BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Phasix Mesh

    K Number: K142818 · Decision Mar 31, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    12
    Applicant Total
    9
    Review Days
    183

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    Basic Information

    Device Name
    Phasix Mesh
    K Number
    K142818
    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
    C. R. Bard
    Date Received
    September 29, 2014
    Decision Date
    March 31, 2015
    Product Code
    OOD
    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
    OOD Surgical Film

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