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

    MOLDEX HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS

    K Number: K062663 · Decision Oct 11, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    34
    Applicant Total
    2
    Review Days
    34

    Basic Information

    Device Name
    MOLDEX HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS
    K Number
    K062663
    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
    MOLDEX/METRIC, INC.
    Date Received
    September 7, 2006
    Decision Date
    October 11, 2006
    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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    Other Clearances by MOLDEX/METRIC, INC.

    K Number Device Name
    K102173 MOLDEX-METRIC HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1712