BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    TMD SAFETY SYRINGE (FA14 SERIES 10ML/FA15 SERIES 20ML)

    K Number: K023458 · Decision Nov 7, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    161
    Applicant Total
    4
    Review Days
    23

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    Basic Information

    Device Name
    TMD SAFETY SYRINGE (FA14 SERIES 10ML/FA15 SERIES 20ML)
    K Number
    K023458
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Taiject Medical Device Co., Ltd.
    Date Received
    October 15, 2002
    Decision Date
    November 7, 2002
    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 Taiject Medical Device Co., Ltd.

    K Number Device Name
    K042426 TMD 0.5ML SAFETY SYRINGE (FA18 SERIES 0.5ML/FA58 SERIES U-100 INSULIN/FA78 SERIES TUBERCULIN)
    K031062 TMD 1ML SAFETY SYRINGE (FA11 SERIES 1ML/FA51 SERIES U-100 INSULIN/FA71 SERIES TUBERCULIN)
    K022278 TMD SAFETY SYRINGE (FA12 SERIES 3ML/FA13 SERIES 5ML)