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

    MAXBRAID POLYESTER PLUS AND POLYETHYLENE PLUS SUTURE

    K Number: K033718 · Decision Feb 12, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    242
    Registration Numbers
    242
    Same Product Code
    173
    Applicant Total
    17
    Review Days
    78

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    Basic Information

    Device Name
    MAXBRAID POLYESTER PLUS AND POLYETHYLENE PLUS SUTURE
    K Number
    K033718
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5000
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Arthrotek, Inc.
    Date Received
    November 26, 2003
    Decision Date
    February 12, 2004
    Product Code
    GAT
    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
    GAT Suture, Nonabsorbable, Synthetic, Polyethylene

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