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

    ComfortGuard Surgical Gown, i600, Film Reinforced

    K Number: K163191 · Decision Feb 27, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    294
    Applicant Total
    3
    Review Days
    105

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    Basic Information

    Device Name
    ComfortGuard Surgical Gown, i600, Film Reinforced
    K Number
    K163191
    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
    Gri Medical & Electrical Technology Co., Ltd.
    Date Received
    November 14, 2016
    Decision Date
    February 27, 2017
    Product Code
    FYA
    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
    FYA Gown, Surgical

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    Other Clearances by Gri Medical & Electrical Technology Co., Ltd.

    K Number Device Name
    K172445 RoyalGuard Surgical Gown, i600, Breathable
    K162442 ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500