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510(k) Data Aggregation

    K Number
    K970987
    Device Name
    ELECTROSURGICAL ELECTRODE
    Manufacturer
    FUSION MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1997-05-05

    (48 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    FUSION MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for use by practitioners in a manner identical to similar electrosurgical electrodes of this type presently in commercial distribution. It is intended to provide electrocautery over a large surface.
    Device Description
    The Fusion Ball Tip Electrode is a reusable electrode for use in monopolar electrosurgical accessories.
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    K Number
    K964857
    Device Name
    RAPISEAL PATCH
    Manufacturer
    FUSION MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1997-02-18

    (76 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    FUSION MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RapiSeal Patch is intended to provide a temporary matrix during the natural tissue repair process, resulting in the additional benefit of hemostatic tamponade.
    Device Description
    The Patch is a bioresorbable film containing gelatin. Each Patch is supplied sterile and non-pyrogenic in a single-use package.
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    K Number
    K961440
    Device Name
    SURGICAL PATCH, SURGICAL MEMBRANE, SURGICAL MESH
    Manufacturer
    FUSION MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1996-05-31

    (46 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    FUSION MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Patch reinforces the soft tissue of the lung thereby sealing or reducing air leaks that occur during pulmonary surgery. • Reinforce soft tissue of the lung • Seal or reduce air leaks in thoracic surgery
    Device Description
    The Patch is a bioresorbable film containing gelatin. Each Patch is supplied sterile and non-pyrogenic in a single-use package. Thin film
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