BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    YI XIN STERILE SYRINGE FOR SINGLE USE

    K Number: K050999 · Decision Sep 2, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    2
    Review Days
    135

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    Basic Information

    Device Name
    YI XIN STERILE SYRINGE FOR SINGLE USE
    K Number
    K050999
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Jiangxi Sanxin (Eversincere) Medical Devices Group
    Date Received
    April 20, 2005
    Decision Date
    September 2, 2005
    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 Jiangxi Sanxin (Eversincere) Medical Devices Group

    K Number Device Name
    K042102 YIXIN SAFETY SYRINGE