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

    Paneffort AAMI Level 3 Isolation Gown

    K Number: K212717 · Decision Nov 30, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    67
    Applicant Total
    2
    Review Days
    460

    Basic Information

    Device Name
    Paneffort AAMI Level 3 Isolation Gown
    K Number
    K212717
    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
    Paneffort, LLC
    Date Received
    August 27, 2021
    Decision Date
    November 30, 2022
    Product Code
    FYC
    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
    FYC Gown, Isolation, Surgical

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    Other Clearances by Paneffort, LLC

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