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

    NIOMED BOUFFANT CAPS

    K Number: K954455 · Decision Jan 23, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    291
    Registration Numbers
    291
    Same Product Code
    31
    Applicant Total
    6
    Review Days
    120

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    Basic Information

    Device Name
    NIOMED BOUFFANT CAPS
    K Number
    K954455
    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
    Amerasia Corp.
    Date Received
    September 25, 1995
    Decision Date
    January 23, 1996
    Product Code
    FYF
    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
    FYF Cap, Surgical

    Similar 510(k) Clearances

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    Other Clearances by Amerasia Corp.

    K Number Device Name
    K955833 NIOMED SURGICAL CAPS
    K954747 NIOMED BARRIER GOWNS
    K954454 NIOMED SURGICAL HOOD
    K952897 NIOMED SHOE COVERS
    K952937 NIOMED NON-SKID SHOE COVERS