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510(k) Data Aggregation

    K Number
    K980049
    Device Name
    BONETRAP
    Manufacturer
    BLADHS PLAST AB
    Date Cleared
    1998-08-11

    (217 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    BLADHS PLAST AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The boneTRAP is designed for use in various oral surgical procedures (implant surgery, periodontal surgery, etc.) where the oral surgeon desires to collect a patient's own bone particles and other tissue fragments for later use in bone or tissue transplantation.
    Device Description
    boneTRAP is a sterile, disposable plastic trap for collecting bone particles.
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