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

    Surgical Face Masks, Model: EFMDS-L50Pn BLU

    K Number: K230380 · Decision Aug 3, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    606
    Applicant Total
    1
    Review Days
    171

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    Basic Information

    Device Name
    Surgical Face Masks, Model: EFMDS-L50Pn BLU
    K Number
    K230380
    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
    Iris USA
    Date Received
    February 13, 2023
    Decision Date
    August 3, 2023
    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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