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510(k) Data Aggregation

    K Number
    K973248
    Device Name
    IMTEC BONE COLLECTOR SYSTEM
    Manufacturer
    Date Cleared
    1997-11-19

    (82 days)

    Product Code
    Regulation Number
    872.6640
    Why did this record match?
    Product Code :

    EHZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IMTEC Bone Collector System is designed to facilitate the collection of autogenous bone particles for use in augmentation procedures. This is accomplished by introducing into the surgical suction line a housing and filter apparatus. Autogenous bone particles which would otherwise be loss into the suction system are trapped in this filter. This material may be easily retrieved for usage.
    Device Description
    The IMTEC Bone Collector System is designed to facilitate the collection of autogeneous bone for use in augmentation procedures. Adapted from an oral suction device it contains a filter cartridge which traps bone particles resulting from drilling into bone. The filter can be removed and the bone particles asceptically collected. The filters are available either sterile/single use or autoclavable. The autoclavable filter cartridge is not recommended for reuse in bone collection augmentation procedures.
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