BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MODIFIED AOR-SULLIVAN PROTECTIVE OVERGLOVE

    K Number: K902016 · Decision May 16, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    801
    Registration Numbers
    801
    Same Product Code
    55
    Applicant Total
    2
    Review Days
    16

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    Basic Information

    Device Name
    MODIFIED AOR-SULLIVAN PROTECTIVE OVERGLOVE
    K Number
    K902016
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Aor-Sullivan
    Date Received
    April 30, 1990
    Decision Date
    May 16, 1990
    Product Code
    LYU
    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
    LYU Accessory, Surgical Apparel

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    Other Clearances by Aor-Sullivan

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    K893118 AOR-SULLIVAN PROTECTIVE OVERGLOVE