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

    CAREO SAFETY SYRINGE FOR U-100 INSULIN

    K Number: K061055 · Decision Jul 10, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    161
    Applicant Total
    5
    Review Days
    84

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    Basic Information

    Device Name
    CAREO SAFETY SYRINGE FOR U-100 INSULIN
    K Number
    K061055
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Life-Shield Products, Inc.
    Date Received
    April 17, 2006
    Decision Date
    July 10, 2006
    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 Life-Shield Products, Inc.

    K Number Device Name
    K072037 CAREO SAFETY SYRINGE FOR U-100 INSULIN 0.5CC/ML
    K060208 CAREO SAFETY SYRINGE 1CC/ML, MODELS CA0106-C,CA0196-C,CA0186-C,CA0107-C,CA0197-C,CA0187-C,CA0104-C,CA0194-C,CA0184-C,
    K052397 CAREO SAFETY SYRINGE (3CC/ML, 5CC/ML, 10CC/ML)
    K030976 CAREO RETRACTABLE SAFETY SYRINGE