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

    Disposable Surgical Face Mask (M663BE, M663BT)

    K Number: K220550 · Decision Jun 14, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    606
    Applicant Total
    4
    Review Days
    109

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    Basic Information

    Device Name
    Disposable Surgical Face Mask (M663BE, M663BT)
    K Number
    K220550
    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 25, 2022
    Decision Date
    June 14, 2022
    Product Code
    FXX
    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
    FXX Mask, 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)
    K020474 MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95