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

    NIOMED SHOE COVERS

    K Number: K952897 · Decision Oct 23, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    282
    Registration Numbers
    282
    Same Product Code
    35
    Applicant Total
    6
    Review Days
    122

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    Basic Information

    Device Name
    NIOMED SHOE COVERS
    K Number
    K952897
    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
    June 23, 1995
    Decision Date
    October 23, 1995
    Product Code
    FXP
    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
    FXP Cover, Shoe, Operating-Room

    Similar 510(k) Clearances

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

    PRIMED SHOE COVERS, PRIMED HEAD COVERS

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

    FAR-EAST SHOE COVERS

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

    CONVERTORS IMPERVIOUS SHOE COVERS

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

    SHOE COVER, NON-STERILE

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

    FLUID BARRIER BOOT KNEE & ANKLE-HIGH

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

    NIOMED NON-SKID SHOE COVERS

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

    Other Clearances by Amerasia Corp.

    K Number Device Name
    K955833 NIOMED SURGICAL CAPS
    K954747 NIOMED BARRIER GOWNS
    K954454 NIOMED SURGICAL HOOD
    K954455 NIOMED BOUFFANT CAPS
    K952937 NIOMED NON-SKID SHOE COVERS