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

    SURGICAL ISOLATION GOWN

    K Number: K171535 · Decision Feb 15, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    67
    Applicant Total
    2
    Review Days
    266

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    Basic Information

    Device Name
    SURGICAL ISOLATION GOWN
    K Number
    K171535
    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
    Jingzhou Haixin Green Cross Medical Products Co., Ltd.
    Date Received
    May 25, 2017
    Decision Date
    February 15, 2018
    Product Code
    FYC
    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
    FYC Gown, Isolation, Surgical

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    Other Clearances by Jingzhou Haixin Green Cross Medical Products Co., Ltd.

    K Number Device Name
    K222266 Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)