BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    FLUSH SYRINGE FILLED WITH 0.9% SODIUM CHLORIDE

    K Number: K090882 · Decision Apr 23, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    39
    Applicant Total
    45
    Review Days
    388

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    Basic Information

    Device Name
    FLUSH SYRINGE FILLED WITH 0.9% SODIUM CHLORIDE
    K Number
    K090882
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hospira, Inc.
    Date Received
    March 31, 2009
    Decision Date
    April 23, 2010
    Product Code
    NGT
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NGT Saline, Vascular Access Flush

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