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

    Aero Chrome* Breathable Performance Surgical Gown

    K Number: K153255 · Decision Apr 13, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    294
    Applicant Total
    7
    Review Days
    155

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    Basic Information

    Device Name
    Aero Chrome* Breathable Performance Surgical Gown
    K Number
    K153255
    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
    Halyard Health, Inc.
    Date Received
    November 10, 2015
    Decision Date
    April 13, 2016
    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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    K Number Device Name
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