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

    BLOOD COLLECTION NEEDLE, MODEL 20G 21G 22G

    K Number: K073127 · Decision Dec 20, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    440
    Registration Numbers
    440
    Same Product Code
    687
    Applicant Total
    7
    Review Days
    44

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    Basic Information

    Device Name
    BLOOD COLLECTION NEEDLE, MODEL 20G 21G 22G
    K Number
    K073127
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shandong Weigao Group Medical Polymer Co., Ltd.
    Date Received
    November 6, 2007
    Decision Date
    December 20, 2007
    Product Code
    FMI
    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
    FMI Needle, Hypodermic, Single Lumen

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    Other Clearances by Shandong Weigao Group Medical Polymer Co., Ltd.

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    K102741 ENTERAL FEEDING BAG AND SETS
    K102328 BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA
    K081241 WEIGAO EMPTY CARTRIDGE SYRINGE
    K072739 JIERUI SYRINGES AND NEEDLES