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

    WHITE KNIGHT DISP. STERILE BACK GOWN

    K Number: K800927 · Decision May 20, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    294
    Applicant Total
    56
    Review Days
    29

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    Basic Information

    Device Name
    WHITE KNIGHT DISP. STERILE BACK GOWN
    K Number
    K800927
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    G.D. Searle and Co.
    Date Received
    April 21, 1980
    Decision Date
    May 20, 1980
    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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