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

    PREHEPARINZED SYRINGE

    K Number: K803302 · Decision Apr 8, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    2
    Review Days
    99

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    Basic Information

    Device Name
    PREHEPARINZED SYRINGE
    K Number
    K803302
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    The University of Chicago
    Date Received
    December 30, 1980
    Decision Date
    April 8, 1981
    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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    Other Clearances by The University of Chicago

    K Number Device Name
    K803182 SYRINGE FOR BLOOD SAMPLING