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

    YIXIN SAFETY SYRINGE

    K Number: K042102 · Decision Mar 8, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    161
    Applicant Total
    2
    Review Days
    216

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    Basic Information

    Device Name
    YIXIN SAFETY SYRINGE
    K Number
    K042102
    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
    August 4, 2004
    Decision Date
    March 8, 2005
    Product Code
    MEG
    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
    MEG Syringe, Antistick

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    Other Clearances by Jiangxi Sanxin (Eversincere) Medical Devices Group

    K Number Device Name
    K050999 YI XIN STERILE SYRINGE FOR SINGLE USE