BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇲 Comoros

    DISPOSABLE SURGICAL GOWNS

    K Number: K120192 · Decision Oct 16, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    287
    Applicant Total
    2
    Review Days
    267

    Basic Information

    Device Name
    DISPOSABLE SURGICAL GOWNS
    K Number
    K120192
    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
    WEIHAI HONGYU NONWOVEN FABRIC PRODUCTS CO., LTD
    Date Received
    January 23, 2012
    Decision Date
    October 16, 2012
    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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