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510(k) Data Aggregation

    K Number
    K143757
    Device Name
    ANUTRA Feedback Aspiration Syringe
    Manufacturer
    ANUTRA MEDICAL, INC.
    Date Cleared
    2015-01-08

    (8 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANUTRA MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ANUTRA Feedback Aspiration Syringe is intended for use by healtheare professionals for general purpose fluid aspiration/injection.
    Device Description
    The ANUTRA Feedback Aspiration Syringe is a piston syringe (control syringe) consisting of a plastic barrel which contains a printed graduated scale (5mL nominal volume) and 6% male Luer Lock connection, a plunger, and a plastic plunger rod. The internal surface of the ANUTRA Feedback Aspiration Syringe barrel is lubricated with polydimethylsiloxane (silicone). The plunger rod design contains a finger ring to allow for ease of use, and tab features with interface with the barrel to provide audible and tactile feedback to the user. The ANUTRA Feedback Aspiration Syringe is single-use only, non-pyrogenic, and sterilized by gamma irradiation.
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