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510(k) Data Aggregation

    K Number
    K060172
    Device Name
    REMA SHAVER BLADES
    Manufacturer
    REMA MEDIZINTECHNIK GMBH.
    Date Cleared
    2006-05-31

    (128 days)

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

    REMA MEDIZINTECHNIK GMBH.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The REMA Shaver Blades are intended to provide shaving, cutting and abrading of bone and tissue during arthroscopic surgical procedures conducted by qualified surgeons.
    Device Description
    The REMA Shaver Blades consists of an outer tube with a hub and a rotating inner tube with a connector. The inner and outer tube consists of stainless steel. The hub and connector can consist of stainless steel or Polyphenylsulfone (PPSU). The components are designed and intended to be operated exclusively as a unit.
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