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

    Bifurcated Needle

    K Number: K222385 · Decision Dec 6, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    24
    Applicant Total
    12
    Review Days
    120

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    Basic Information

    Device Name
    Bifurcated Needle
    K Number
    K222385
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Anhui Tiankang Medical Technology Co., Ltd.
    Date Received
    August 8, 2022
    Decision Date
    December 6, 2022
    Product Code
    SCL
    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
    SCL Allergen And Vaccine Delivery Needles

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