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    K Number
    K082750
    Device Name
    ENTACT SEPTAL STAPLER, MODEL 610-00100
    Manufacturer
    ENTRIGUE SURGICAL, INC.
    Date Cleared
    2009-01-06

    (109 days)

    Product Code
    OLL
    Regulation Number
    878.4750
    Why did this record match?
    Product Code :

    OLL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ENTact™ Septal Stapler delivers implantable septal staples which are intended to connect internal tissues to aid healing and for approximation of soft tissues during nasal septal surgery.
    Device Description
    The ENTact™ Septal Stapler consists of resorbable fixation devices, which are delivered via an manual surgical stapler delivery system. The ENTact™ implantable septal staples, composed of an absorbable copolymer, may be used during nasal surgery to approximate the mucoperichondrial flaps of the nasal septum and at the completion of surgery. The staples are provided preloaded in a single-use, disposable stapler.
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