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510(k) Data Aggregation

    K Number
    K111979
    Device Name
    RADIOACTIVE SEED LOCALIZATION NEEDLE
    Date Cleared
    2011-10-18

    (98 days)

    Product Code
    Regulation Number
    892.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOCOMPATIBLES INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BrachySciences Radioactive Seed Localization Needle with AnchorSeed is intended for the localization of suspicious tissues (non-palpable lesions) for excision in the use of radioactive seeds.
    Device Description
    BrachySciences Radioactive Seed Localization Needle with AnchorSeed.
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