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

    DISPOSABLE SHOE COVER

    K Number: K913628 · Decision Oct 4, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    282
    Registration Numbers
    282
    Same Product Code
    35
    Applicant Total
    2
    Review Days
    50

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    Basic Information

    Device Name
    DISPOSABLE SHOE COVER
    K Number
    K913628
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Gem Nonwovews, Inc.
    Date Received
    August 15, 1991
    Decision Date
    October 4, 1991
    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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    Other Clearances by Gem Nonwovews, Inc.

    K Number Device Name
    K913700 DISPOSABLE BOUFFANT CAP