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510(k) Data Aggregation

    K Number
    K092533
    Device Name
    FORCE FIBER BLUE ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES
    Manufacturer
    BEERE PRECISION MEDICAL INSTRUMENTS, KMEDIC, TELEF
    Date Cleared
    2009-09-15

    (27 days)

    Product Code
    GAT
    Regulation Number
    878.5000
    Why did this record match?
    Applicant Name (Manufacturer) :

    BEERE PRECISION MEDICAL INSTRUMENTS, KMEDIC, TELEF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Force Fiber® Blue Ultra High Molecular Weight Polyethylene Non-Absorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including use in cardiovascular surgeries and the use of allograft tissue for orthopaedic surgeries.
    Device Description
    The Force Fiber® Polyethylene is non-absorbable, sterile, surgical suture composed of ultra high molecular weight polyethylene (UHMWPE). It is available as 100% blue (UHMWPE), sizes 0, 1 and 2 meeting USP requirements except for oversized dis neter.
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