BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ISOLATION GOWNS

    K Number: K922442 · Decision Oct 12, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    67
    Applicant Total
    2
    Review Days
    508

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    Basic Information

    Device Name
    ISOLATION GOWNS
    K Number
    K922442
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pfb Inter-Apparel Corp.
    Date Received
    May 22, 1992
    Decision Date
    October 12, 1993
    Product Code
    FYC
    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
    FYC Gown, Isolation, Surgical

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    Other Clearances by Pfb Inter-Apparel Corp.

    K Number Device Name
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