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

    Master-Frank N95 Particulate Respirator

    K Number: K172963 · Decision Apr 4, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    224
    Registration Numbers
    224
    Same Product Code
    34
    Applicant Total
    1
    Review Days
    190

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    Basic Information

    Device Name
    Master-Frank N95 Particulate Respirator
    K Number
    K172963
    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
    Master & Frank Enterprise Co., Ltd.
    Date Received
    September 26, 2017
    Decision Date
    April 4, 2018
    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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