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510(k) Data Aggregation

    K Number
    K082460
    Device Name
    CENEFOM PVA SURGICAL SPEAR
    Manufacturer
    LONGTEK SCIENTIFIC CO., LTD.
    Date Cleared
    2008-12-15

    (111 days)

    Product Code
    HOZ
    Regulation Number
    886.4790
    Why did this record match?
    Applicant Name (Manufacturer) :

    LONGTEK SCIENTIFIC CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cenefom PVA Surgical Spear is indicated for short-term transient use in ophthalmic surgical procedures for absorbing excess fluids from the operative field.
    Device Description
    Not Found
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