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

    COATED NOVAFIL, POLYBUTESTER, MESH

    K Number: K896946 · Decision May 7, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    162
    Applicant Total
    7
    Review Days
    145

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    Basic Information

    Device Name
    COATED NOVAFIL, POLYBUTESTER, MESH
    K Number
    K896946
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    American Cyanamid Co.
    Date Received
    December 13, 1989
    Decision Date
    May 7, 1990
    Product Code
    FTM
    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
    FTM Mesh, Surgical

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