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

    JIERUI SYRINGES AND NEEDLES

    K Number: K072739 · Decision Mar 21, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    161
    Applicant Total
    7
    Review Days
    176

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    Basic Information

    Device Name
    JIERUI SYRINGES AND NEEDLES
    K Number
    K072739
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shandong Weigao Group Medical Polymer Co., Ltd.
    Date Received
    September 27, 2007
    Decision Date
    March 21, 2008
    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 Shandong Weigao Group Medical Polymer Co., Ltd.

    K Number Device Name
    K212207 Sterile Hypodermic Syringe for Single Use
    K212920 Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use
    K102741 ENTERAL FEEDING BAG AND SETS
    K102328 BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA
    K081241 WEIGAO EMPTY CARTRIDGE SYRINGE
    K073127 BLOOD COLLECTION NEEDLE, MODEL 20G 21G 22G