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    K Number
    K021481
    Device Name
    BRESAGEN CATHETER, MODEL CS-3000
    Manufacturer
    BRESAGEN, INC.
    Date Cleared
    2002-08-06

    (90 days)

    Product Code
    HCA
    Regulation Number
    882.4100
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRESAGEN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For injection of material into, or removal of material from, the mendou over I or any intracranial procedures. This device is not intended for implant. This device is ETO sterilized and intended for one time use only.
    Device Description
    Bresagen Catheter, Model CS-3000
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