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

    TECNOL PERSONAL SHOE COVER

    K Number: K861528 · Decision May 12, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    282
    Registration Numbers
    282
    Same Product Code
    35
    Applicant Total
    2
    Review Days
    18

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    Basic Information

    Device Name
    TECNOL PERSONAL SHOE COVER
    K Number
    K861528
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Technol, Inc.
    Date Received
    April 24, 1986
    Decision Date
    May 12, 1986
    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 Technol, Inc.

    K Number Device Name
    K884132 TECNOL BUCKS TRACTION W/HEEL PROTECTOR