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

    NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE

    K Number: K002755 · Decision Dec 4, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    7
    Applicant Total
    27
    Review Days
    90

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    Basic Information

    Device Name
    NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE
    K Number
    K002755
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    T. Korossurgical Instruments Corp.
    Date Received
    September 5, 2000
    Decision Date
    December 4, 2000
    Product Code
    LRN
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LRN Wire, Surgical

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