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510(k) Data Aggregation

    K Number
    K132883
    Device Name
    HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS)
    Manufacturer
    HEMODIA S.A.S.
    Date Cleared
    2013-11-01

    (49 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEMODIA S.A.S.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device intended to be used in conjunction with the FMS/Depuy/Mitek arthroscopic pump systems and delivers irrigation fluid both to and from the pump and to and from the operative site during arthroscopic procedures.
    Device Description
    HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS) are tube sets that deliver irrigation fluid both to and from the pump and to and from the operative site during arthroscopic procedures.
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