BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    Cufitec Surgical Mask

    K Number: K182766 · Decision Jan 3, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    97

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    Basic Information

    Device Name
    Cufitec Surgical Mask
    K Number
    K182766
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nbc Meshtec, Inc.
    Date Received
    September 28, 2018
    Decision Date
    January 3, 2019
    Product Code
    OUK
    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
    OUK Surgical Mask With Antimicrobial/Antiviral Agent

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