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

    COVER, SHOE OPERATING ROOM

    K Number: K865023 · Decision Jan 12, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    282
    Registration Numbers
    282
    Same Product Code
    35
    Applicant Total
    21
    Review Days
    20

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    Basic Information

    Device Name
    COVER, SHOE OPERATING ROOM
    K Number
    K865023
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Ulti-Med Intl., Inc.
    Date Received
    December 23, 1986
    Decision Date
    January 12, 1987
    Product Code
    FXP
    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
    FXP Cover, Shoe, Operating-Room

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