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

    BARRIER* EXTRA PROTECTION PLUS SURGICAL GOWN

    K Number: K932731 · Decision Apr 11, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    6
    Applicant Total
    53
    Review Days
    308

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    Basic Information

    Device Name
    BARRIER* EXTRA PROTECTION PLUS SURGICAL GOWN
    K Number
    K932731
    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
    Johnson & Johnson Medical, Inc.
    Date Received
    June 7, 1993
    Decision Date
    April 11, 1994
    Product Code
    FYE
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FYE Dress, Surgical

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