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

    Dukal Corporation AAMI Level 4 Open-Back Protective Gown

    K Number: K212464 · Decision Mar 30, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    8
    Applicant Total
    5
    Review Days
    236

    Basic Information

    Device Name
    Dukal Corporation AAMI Level 4 Open-Back Protective Gown
    K Number
    K212464
    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
    Dukal Corporation
    Date Received
    August 6, 2021
    Decision Date
    March 30, 2022
    Product Code
    QPC
    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
    QPC Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection

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