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

    POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES

    K Number: K961389 · Decision Jun 18, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    84
    Applicant Total
    5
    Review Days
    69

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    Basic Information

    Device Name
    POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES
    K Number
    K961389
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5010
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    R. K. Medical L. L. C.
    Date Received
    April 10, 1996
    Decision Date
    June 18, 1996
    Product Code
    GAW
    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
    GAW Suture, Nonabsorbable, Synthetic, Polypropylene

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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
    K960328 SILK NONABSORBABLE SURGICAL SUTURES USP
    K960327 NYLON NOABSORBABLE SURGICAL SUTURES USP