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

    SILK NONABSORBABLE SURGICAL SUTURES USP

    K Number: K960328 · Decision Mar 4, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    120
    Registration Numbers
    120
    Same Product Code
    40
    Applicant Total
    5
    Review Days
    40

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    Basic Information

    Device Name
    SILK NONABSORBABLE SURGICAL SUTURES USP
    K Number
    K960328
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5030
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    R. K. Medical L. L. C.
    Date Received
    January 24, 1996
    Decision Date
    March 4, 1996
    Product Code
    GAP
    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
    GAP Suture, Nonabsorbable, Silk

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    Other Clearances by R. K. Medical L. L. C.

    K Number Device Name
    K961931 PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP
    K961925 POLYESTER NONABSORBABLE SURGICAL SUTURES USP
    K961389 POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES
    K960327 NYLON NOABSORBABLE SURGICAL SUTURES USP