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510(k) Data Aggregation

    K Number
    K092538
    Device Name
    REFINE SUPPORT SYSTEM, MODEL 100.0100
    Manufacturer
    ALURE MEDICAL INC.
    Date Cleared
    2010-03-05

    (198 days)

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

    ALURE MEDICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Refine™ Support System is indicated for reinforcement of soft tissue in plastic or reconstructive procedures.
    Device Description
    The Refine™ Support System consists of a non-absorbable implant and a delivery system. The implant is comprised of a section of mesh with suture tails containing suture barbs for tissue securement. The device and the delivery system are delivered sterile and are for single use only.
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    K Number
    K083102
    Device Name
    REFINE LIFT SYSTEM
    Manufacturer
    ALURE MEDICAL INC.
    Date Cleared
    2009-05-11

    (203 days)

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

    ALURE MEDICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Refine™ Support System is indicated for reinforcement of soft tissue in plastic or reconstructive procedures.
    Device Description
    The Refine™ Support System consists of a non-absorbable implant and a delivery system. The implant consists of a mesh and suture anchor. The device and the delivery system are delivered sterile and are for single use only.
    Ask a Question

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