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

    BAIXIN DISPOSABLE SYRINGE, MULTIPLE SIZES

    K Number: K083686 · Decision Jul 2, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    2
    Review Days
    202

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    Basic Information

    Device Name
    BAIXIN DISPOSABLE SYRINGE, MULTIPLE SIZES
    K Number
    K083686
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Anhui Kangda Medical Products Co., Ltd.
    Date Received
    December 12, 2008
    Decision Date
    July 2, 2009
    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 Anhui Kangda Medical Products Co., Ltd.

    K Number Device Name
    K083687 BAIXIN INTRAVASCULAR ADMINISTRATION SET