BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028

    K Number: K072067 · Decision Jan 8, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    224
    Registration Numbers
    224
    Same Product Code
    34
    Applicant Total
    1
    Review Days
    165

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    Basic Information

    Device Name
    N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028
    K Number
    K072067
    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
    Shuenn Bao Shing Corporation
    Date Received
    July 27, 2007
    Decision Date
    January 8, 2008
    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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