BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Surgical face mask (Model: Flat Ear Loop/CN102)

    K Number: K203534 · Decision Jul 21, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    606
    Applicant Total
    2
    Review Days
    231

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    Basic Information

    Device Name
    Surgical face mask (Model: Flat Ear Loop/CN102)
    K Number
    K203534
    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
    Crown Name Disposable Hygiene Products Fty., Ltd.
    Date Received
    December 2, 2020
    Decision Date
    July 21, 2021
    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 Crown Name Disposable Hygiene Products Fty., Ltd.

    K Number Device Name
    K212422 Disposable Surgical Isolation Gown