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

    NIOMED BARRIER GOWNS

    K Number: K954747 · Decision Mar 6, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    67
    Applicant Total
    6
    Review Days
    142

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    Basic Information

    Device Name
    NIOMED BARRIER GOWNS
    K Number
    K954747
    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
    Amerasia Corp.
    Date Received
    October 16, 1995
    Decision Date
    March 6, 1996
    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 Amerasia Corp.

    K Number Device Name
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    K954454 NIOMED SURGICAL HOOD
    K954455 NIOMED BOUFFANT CAPS
    K952897 NIOMED SHOE COVERS
    K952937 NIOMED NON-SKID SHOE COVERS