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

    STERILE PLAIN GUT/CHROMIC GUT ABSORB SURG SUTURES

    K Number: K911354 · Decision Oct 25, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    29
    Applicant Total
    10
    Review Days
    213

    Basic Information

    Device Name
    STERILE PLAIN GUT/CHROMIC GUT ABSORB SURG SUTURES
    K Number
    K911354
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4830
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    INTERNACIONAL FARMACEUTICA, S.A. DE C.V.
    Date Received
    March 26, 1991
    Decision Date
    October 25, 1991
    Product Code
    GAL
    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
    GAL Suture, Absorbable, Natural

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