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

    NIOMED SURGICAL CAPS

    K Number: K955833 · Decision Mar 15, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    291
    Registration Numbers
    291
    Same Product Code
    31
    Applicant Total
    6
    Review Days
    80

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    Basic Information

    Device Name
    NIOMED SURGICAL CAPS
    K Number
    K955833
    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
    December 26, 1995
    Decision Date
    March 15, 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

    Other 510(k) clearances with the same product code (FYF), ordered by most recent decision date.

    SHOE COVER

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    FDA Class 1 ·General, Plastic Surgery

    SURGICAL CAP

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    NIOMED SURGICAL HOOD

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    FDA Class 1 ·General, Plastic Surgery

    NIOMED BOUFFANT CAPS

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    FDA Class 1 ·General, Plastic Surgery

    SURGEON'S CAP

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    BOUFFANT CAP

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    FDA Class 1 ·General, Plastic Surgery
    View all

    Other Clearances by Amerasia Corp.

    K Number Device Name
    K954747 NIOMED BARRIER GOWNS
    K954454 NIOMED SURGICAL HOOD
    K954455 NIOMED BOUFFANT CAPS
    K952897 NIOMED SHOE COVERS
    K952937 NIOMED NON-SKID SHOE COVERS