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

    DISPOSABLE MEDICAL GOWNS

    K Number: K891820 · Decision Jul 24, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    126

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    Basic Information

    Device Name
    DISPOSABLE MEDICAL GOWNS
    K Number
    K891820
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Bioshield, Inc.
    Date Received
    March 20, 1989
    Decision Date
    July 24, 1989
    Product Code
    FYB
    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
    FYB Gown, Patient

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