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

    PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S

    K Number: K041855 · Decision Nov 10, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    224
    Registration Numbers
    224
    Same Product Code
    34
    Applicant Total
    1
    Review Days
    124

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    Basic Information

    Device Name
    PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S
    K Number
    K041855
    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
    Aearo Co.
    Date Received
    July 9, 2004
    Decision Date
    November 10, 2004
    Product Code
    MSH
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    Y

    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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