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

    AERO CHROME* Breathable Performance Surgical Gowns

    K Number: K200522 · Decision Mar 16, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    294
    Applicant Total
    24
    Review Days
    14

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    Basic Information

    Device Name
    AERO CHROME* Breathable Performance Surgical Gowns
    K Number
    K200522
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    O&M Halyard, Inc.
    Date Received
    March 2, 2020
    Decision Date
    March 16, 2020
    Product Code
    FYA
    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
    FYA Gown, Surgical

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