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    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    BIOTOP HOOKSAFE U-100 INSULIN SYRINGE, MODELS 0.5CC/ML AND 1CC/ML

    K Number: K062318 · Decision Jan 3, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    161
    Applicant Total
    4
    Review Days
    147

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    Basic Information

    Device Name
    BIOTOP HOOKSAFE U-100 INSULIN SYRINGE, MODELS 0.5CC/ML AND 1CC/ML
    K Number
    K062318
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biotop Technology Co., Ltd.
    Date Received
    August 9, 2006
    Decision Date
    January 3, 2007
    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 Biotop Technology Co., Ltd.

    K Number Device Name
    K043038 BIOTOP HOOKSAFE LUER-LOCK SAFETY SYRINGE, MODELS 3CC/ML, 5CC/ML AND 10CC/ML
    K041970 BIOTOP HOOKSAFE SAFETY SYRINGE, MODELS 0.5CC/ML, 1CC/ML, 3CC/ML, 5CC/ML AND 10CC/ML
    K032747 BIOTOP DJT-A SAFETY SYRINGE