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

    MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95

    K Number: K020474 · Decision Jul 23, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    224
    Registration Numbers
    224
    Same Product Code
    34
    Applicant Total
    4
    Review Days
    161

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    Basic Information

    Device Name
    MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95
    K Number
    K020474
    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
    Makrite Industries, Inc.
    Date Received
    February 12, 2002
    Decision Date
    July 23, 2002
    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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    Other Clearances by Makrite Industries, Inc.

    K Number Device Name
    K252650 Disposable Medical Face Mask
    K240258 Disposable Medical Face Mask (M643BE)
    K220550 Disposable Surgical Face Mask (M663BE, M663BT)