BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SHANGHAI GANGHAI MODEL GIKO 1400

    K Number: K063334 · Decision Dec 8, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    224
    Registration Numbers
    224
    Same Product Code
    34
    Applicant Total
    1
    Review Days
    32

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    Basic Information

    Device Name
    SHANGHAI GANGHAI MODEL GIKO 1400
    K Number
    K063334
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shanghai Gangkai Purifying Products Co., Ltd.
    Date Received
    November 6, 2006
    Decision Date
    December 8, 2006
    Product Code
    MSH
    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
    MSH Respirator, Surgical

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