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510(k) Data Aggregation

    K Number
    K002753
    Device Name
    SPARTAN A-10
    Manufacturer
    SPARTAN ULTRASONICS, INC.
    Date Cleared
    2000-12-04

    (90 days)

    Product Code
    ELC
    Regulation Number
    872.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPARTAN ULTRASONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K991888
    Device Name
    MINIJECT
    Manufacturer
    SPARTAN ULTRASONICS, INC.
    Date Cleared
    1999-08-25

    (84 days)

    Product Code
    EJI
    Regulation Number
    872.6770
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPARTAN ULTRASONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is intended to be used to administer intraligamental injections of anaesthetic product, through a two-ended needle.
    Device Description
    The Miniiect Syringe is a cartridge syringe with a metal syringe barrel to which the metal or plastic hub of the injection needle is threaded. The barrel accommodates a 1.8cc anesthetic cartridge. The syringe has a plunger on one end, which engages the rubber piston of the anesthetic cartridge. These characteristics are the same or similar for the "Intralig", by Miltex, (K823536) and Ligmaject, (K802483).
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