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

    Cardinal HealthTM Poly-Coated Open-Back Protective Gown

    K Number: K182830 · Decision Apr 26, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    9
    Applicant Total
    26
    Review Days
    203

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    Basic Information

    Device Name
    Cardinal HealthTM Poly-Coated Open-Back Protective Gown
    K Number
    K182830
    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
    Cardinal Health200, LLC
    Date Received
    October 5, 2018
    Decision Date
    April 26, 2019
    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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