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510(k) Data Aggregation

    K Number
    K032417
    Device Name
    HEPARIN LOCK FLUSH SYRINGE
    Manufacturer
    AM2 PAT INC.
    Date Cleared
    2003-12-23

    (140 days)

    Product Code
    FOZ, NGT
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    AM2 PAT INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Heparin Lock Flush Syringe, 10 and 100 units/mL, is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices.
    Device Description
    The proposed device is a sterile, single use, standard piston type syringe that is available in various fill volumes and syringe sizes containing either 10 or 100 USP u/ml Heparin Lock Flush Solution for anits Injection. The syringe uses a sterile, polypropylene luer lock fitting or blunt tip cannula. The piston syrings consists of a polypropylene barrel with a lucr lock adapter assembled with a polypropylene plunger and a polyisoprene seal. The dispensing end of the syringe is covered with a tip cap closure.
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