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

    FLEXON AND STAINLESS STEEL SUTURES

    K Number: K930992 · Decision Dec 17, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    31
    Applicant Total
    7
    Review Days
    295

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    Basic Information

    Device Name
    FLEXON AND STAINLESS STEEL SUTURES
    K Number
    K930992
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4495
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    American Cyanamid Co.
    Date Received
    February 25, 1993
    Decision Date
    December 17, 1993
    Product Code
    GAQ
    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
    GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile

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