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510(k) Data Aggregation

    K Number
    K051256
    Device Name
    SILVERSEAL ORTHOTIC COMPONENT WITH X-STATIC
    Manufacturer
    NOBLE FIBER TECHNOLOGIES, INC.
    Date Cleared
    2005-07-21

    (66 days)

    Product Code
    ISH
    Regulation Number
    890.3420
    Why did this record match?
    Product Code :

    ISH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SILVERSEAL® Orthotic Components with X-Static® are used as components on various orthotic devices intended for medical purposes that can be worn as a cervical collar or brace. The component comprises a knitted stockinette which is made of 90% cotton or polyester, and 10% X-Static®, which is 1.5% silver oxide. The component provides the skin with an antimicrobial barrier.
    Device Description
    SILVERSEAL® Orthotic Components with X-Static® are made of flexible, non-adherent fabric consisting of a knitted or made or in fabric which is 90% cotton or polyester, and 10% of a continuous nylon fiber substrate with a metallic silver surface containing approximately 1.5% silver oxide.
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