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510(k) Data Aggregation

    K Number
    K973587
    Device Name
    EXMOOR TYMPANOCENTESIS KIT (TK/1)
    Manufacturer
    EXMOOR PLASTICS LTD.
    Date Cleared
    1998-01-23

    (123 days)

    Product Code
    JZF
    Regulation Number
    874.4420
    Why did this record match?
    Product Code :

    JZF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to collect middle ear fluid within the viscosity range of sae 30-50 for laboratory analysis. Requirement for aspiration and analysis of middle ear fluid from behind an intact tympanic membrane (ear drum)
    Device Description
    This single use device is designed to collect specimens of middle ear fluid from behind an intact tympanic membrane and comprises the following: polythene disposal bag, glove (examination), 'Disposafe' (for sharps), fenestrated surgical ear drape, mop, label, vial assembly, suction tube (hand-piece), myringotome (aspirating), specimen bag (laboratory), aural speculum, 2.5mm. It has been sterilized by gamma irradiation and is ready for use.
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