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

    JMS SYRINGE

    K Number: K132321 · Decision Feb 20, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    553
    Registration Numbers
    553
    Same Product Code
    738
    Applicant Total
    6
    Review Days
    210

    Basic Information

    Device Name
    JMS SYRINGE
    K Number
    K132321
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    JMS NORTH AMERICA CORPORATION
    Date Received
    July 25, 2013
    Decision Date
    February 20, 2014
    Product Code
    FMF
    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
    FMF Syringe, Piston

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