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

    FLARE DIS. CONDUCTIVE&NON. SHOE COVERS

    K Number: K800809 · Decision May 20, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    282
    Registration Numbers
    282
    Same Product Code
    35
    Applicant Total
    2
    Review Days
    40

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    Basic Information

    Device Name
    FLARE DIS. CONDUCTIVE&NON. SHOE COVERS
    K Number
    K800809
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Flare Products, Inc.
    Date Received
    April 10, 1980
    Decision Date
    May 20, 1980
    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

    Similar 510(k) Clearances

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    NIOMED SHOE COVERS

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    Other Clearances by Flare Products, Inc.

    K Number Device Name
    K800810 FLARE DIS. NONWOVEN HEAD COVERS