BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇷 Türkiye

    Myflon Surgical Mask Level 3

    K Number: K212111 · Decision Jan 23, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    329
    Registration Numbers
    329
    Same Product Code
    598
    Applicant Total
    2
    Review Days
    201

    Basic Information

    Device Name
    Myflon Surgical Mask Level 3
    K Number
    K212111
    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
    Feliks Plastik Laminasyon Ve Ambalaj Malzemeleri Sanayi
    Date Received
    July 6, 2021
    Decision Date
    January 23, 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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