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    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture,

    K Number: K160705 · Decision Nov 23, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    84
    Registration Numbers
    84
    Same Product Code
    63
    Applicant Total
    2
    Review Days
    254

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    Basic Information

    Device Name
    Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture,
    K Number
    K160705
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4840
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Y. Jacobs Medical, Inc.
    Date Received
    March 14, 2016
    Decision Date
    November 23, 2016
    Product Code
    NEW
    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
    NEW Suture, Surgical, Absorbable, Polydioxanone

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    Other Clearances by Y. Jacobs Medical, Inc.

    K Number Device Name
    K143413 J+PRAS YOUNG'S Thread