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

    DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P.

    K Number: K900198 · Decision Jul 5, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    6
    Applicant Total
    7
    Review Days
    170

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    Basic Information

    Device Name
    DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P.
    K Number
    K900198
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4830
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    American Cyanamid Co.
    Date Received
    January 16, 1990
    Decision Date
    July 5, 1990
    Product Code
    GAN
    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
    GAN Suture, Absorbable, Synthetic

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