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

    STERILE STAINLESS STEEL MONOFIL NONABSORB SURG SUT

    K Number: K913185 · Decision Dec 4, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    31
    Applicant Total
    10
    Review Days
    139

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    Basic Information

    Device Name
    STERILE STAINLESS STEEL MONOFIL NONABSORB SURG SUT
    K Number
    K913185
    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
    Internacional Farmaceutica, S.A. DE C.V.
    Date Received
    July 18, 1991
    Decision Date
    December 4, 1991
    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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    K041048 POLYDIOXANONE SYNTHETIC ABSORBABLE SURGICAL SUTURE
    K040282 ATRAMAT AND SORB-FAST POLYGLYCOLIC ACID
    K911354 STERILE PLAIN GUT/CHROMIC GUT ABSORB SURG SUTURES
    K911189 STERILE POLYPROPYLENE MONFIL NONABSORB SURG SUTURE
    K905287 IFSA STERILE SILK BRAIDED NONABSOR SURG SUTURES
    K905286 IFSA STERILE NLYLON MONOFIL NONABSOR SURG SUTURES
    K905285 IFSA STERILE BRAIDED POLY NONABSOR SURG SUTURES