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

    PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP

    K Number: K961931 · Decision Jul 29, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    29
    Applicant Total
    5
    Review Days
    73

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    Basic Information

    Device Name
    PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP
    K Number
    K961931
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4830
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    R. K. Medical L. L. C.
    Date Received
    May 17, 1996
    Decision Date
    July 29, 1996
    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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    Other Clearances by R. K. Medical L. L. C.

    K Number Device Name
    K961925 POLYESTER NONABSORBABLE SURGICAL SUTURES USP
    K961389 POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES
    K960328 SILK NONABSORBABLE SURGICAL SUTURES USP
    K960327 NYLON NOABSORBABLE SURGICAL SUTURES USP