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

    SILK SUTURE

    K Number: K982853 · Decision Apr 30, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    120
    Registration Numbers
    120
    Same Product Code
    40
    Applicant Total
    45
    Review Days
    260

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    Basic Information

    Device Name
    SILK SUTURE
    K Number
    K982853
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5030
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Davis & Geck, Inc.
    Date Received
    August 13, 1998
    Decision Date
    April 30, 1999
    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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