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

    iMask Disposable Surgical Face Mask

    K Number: K201182 · Decision Feb 19, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    606
    Applicant Total
    8
    Review Days
    294

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    Basic Information

    Device Name
    iMask Disposable Surgical Face Mask
    K Number
    K201182
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pac-Dent, Inc.
    Date Received
    May 1, 2020
    Decision Date
    February 19, 2021
    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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