BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE

    K Number: K152803 · Decision Jul 12, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    2
    Review Days
    288

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    Basic Information

    Device Name
    SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE
    K Number
    K152803
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sung Shim Medicare Co., Ltd.
    Date Received
    September 28, 2015
    Decision Date
    July 12, 2016
    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 Sung Shim Medicare Co., Ltd.

    K Number Device Name
    K152334 Sungshim Insulin Pen Needle