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

    DemeMASK

    K Number: K201479 · Decision Jul 24, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    606
    Applicant Total
    5
    Review Days
    50

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    Basic Information

    Device Name
    DemeMASK
    K Number
    K201479
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Demetech Corporation
    Date Received
    June 4, 2020
    Decision Date
    July 24, 2020
    Product Code
    FXX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FXX Mask, Surgical

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    Other Clearances by Demetech Corporation

    K Number Device Name
    K191361 DemeDIOX Barbed Absorbable Surgical Suture
    K190777 DemeTECH DemeFORCE Nonabsorbable Surgical Suture
    K181578 DemeTECH PTFE Nonabsorbable Surgical Suture
    K181582 DemeTECH DemeDIOX absorbable surgical suture