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

    DemeTECH PTFE Nonabsorbable Surgical Suture

    K Number: K181578 · Decision Oct 11, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    16
    Applicant Total
    5
    Review Days
    118

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    Basic Information

    Device Name
    DemeTECH PTFE Nonabsorbable Surgical Suture
    K Number
    K181578
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5035
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Demetech Corporation
    Date Received
    June 15, 2018
    Decision Date
    October 11, 2018
    Product Code
    NBY
    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
    NBY Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

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    Other Clearances by Demetech Corporation

    K Number Device Name
    K201479 DemeMASK
    K191361 DemeDIOX Barbed Absorbable Surgical Suture
    K190777 DemeTECH DemeFORCE Nonabsorbable Surgical Suture
    K181582 DemeTECH DemeDIOX absorbable surgical suture